<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02219308</url>
  </required_header>
  <id_info>
    <org_study_id>141025</org_study_id>
    <nct_id>NCT02219308</nct_id>
  </id_info>
  <brief_title>Pain Control for Intrauterine Device Placement Using Paracervical Block</brief_title>
  <official_title>Pain Control for Intrauterine Device Placement: A Randomized Controlled Trial of Paracervical Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intrauterine device (IUD) placement can be painful for patients during and after the&#xD;
      procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly&#xD;
      effective long acting reversible contraception. Currently there are no proven effective&#xD;
      methods for reduction of pain during and after placement of modern IUDs. Paracervical block&#xD;
      pain may decrease this placement pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Modern IUDs are highly effective long acting reversible forms of contraception. The Mirena&#xD;
      IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing&#xD;
      pregnancy. Fear of IUD placement can be a barrier to obtaining this highly effective form of&#xD;
      birth control. The current standard of care for pain management during and after IUD&#xD;
      placement is no medication, as randomized control trials published to date have limited data&#xD;
      regarding use of medications to decrease pain. There has been one trial to suggest that the&#xD;
      use of naproxen with 1% lidocaine paracervical block (PCB) compared to PCB alone may decrease&#xD;
      pain after IUD placement in primarily nulliparous patients. However, this study was with the&#xD;
      much wider and no longer available Dalkon Shield IUD. In addition, this study did not show&#xD;
      any significant decrease in pain scores during IUD placement. Studies to evaluate&#xD;
      effectiveness of ibuprofen and misoprostol have shown no significant decrease in pain scores&#xD;
      during and after IUD insertion, although the majority of participants in these studies were&#xD;
      multiparous. There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion&#xD;
      may have some decrease in pain, although this study was poorly designed.&#xD;
&#xD;
      Although there is no standard of care in regards to pain medication administration prior to&#xD;
      IUD placement, providers often suggest paracervical prior IUD insertion among nulliparous&#xD;
      women. Therefore the primary aim of this study is to determine whether a paracervical block&#xD;
      (PCB) decreases pain associated with intrauterine device (IUD) placement compared to no&#xD;
      paracervical block. We hypothesize that administration of a PCB of 20 mL 1% buffered&#xD;
      lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual&#xD;
      analog scale at various time points during IUD placement when compared to no paracervical&#xD;
      block.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain With Intrauterine Device (IUD) Placement</measure>
    <time_frame>Moment of IUD insertion</time_frame>
    <description>Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median Pain Scores for All Time Points</measure>
    <time_frame>Anticipation of procedure through 5 minutes after IUD placement</time_frame>
    <description>Distance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Pain Due to Intrauterine Contraceptive Device</condition>
  <arm_group>
    <arm_group_label>Paracervical Block (PCB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.&#xD;
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Paracervical Block (Sham PCB)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.&#xD;
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Paracervical Block (PCB)</intervention_name>
    <description>Drug: 1% Lidocaine Hydrochloride&#xD;
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.&#xD;
IUD placement then proceeds</description>
    <arm_group_label>Paracervical Block (PCB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No Paracervical Block (Sham PCB)</intervention_name>
    <description>Drug: 1% Lidocaine Hydrochloride&#xD;
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.&#xD;
IUD placement then proceeds</description>
    <arm_group_label>No Paracervical Block (Sham PCB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nulliparous women&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  Present for intrauterine device placement for contraception or menorrhagia (in the&#xD;
             case of Mirena IUD insertion).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea,&#xD;
             irritable bowel syndrome, interstitial cystitis)&#xD;
&#xD;
          -  If the patient has taken any pain medications within 6 hours of enrollment, including&#xD;
             aspirin or other NSAIDs&#xD;
&#xD;
          -  Misoprostol administration within 24 hours of enrollment&#xD;
&#xD;
          -  History of prior IUD insertion&#xD;
&#xD;
          -  Known contraindications to IUD&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheila Mody, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Planned Parenthood Mission Bay Parker Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.</citation>
    <PMID>19588429</PMID>
  </reference>
  <reference>
    <citation>Cetin A, Cetin M. Effect of deep injections of local anesthetics and basal dilatation of cervix in management of pain during legal abortions. A randomized, controlled study. Contraception. 1997 Aug;56(2):85-7. doi: 10.1016/s0010-7824(97)00096-6.</citation>
    <PMID>9315416</PMID>
  </reference>
  <reference>
    <citation>Edelman AB, Schaefer E, Olson A, Van Houten L, Bednarek P, Leclair C, Jensen JT. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011 Sep;84(3):234-9. doi: 10.1016/j.contraception.2011.01.016. Epub 2011 Mar 3.</citation>
    <PMID>21843686</PMID>
  </reference>
  <reference>
    <citation>Hubacher D, Reyes V, Lillo S, Zepeda A, Chen PL, Croxatto H. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol. 2006 Nov;195(5):1272-7. doi: 10.1016/j.ajog.2006.08.022.</citation>
    <PMID>17074548</PMID>
  </reference>
  <reference>
    <citation>Maguire et al. &quot;Intracervical lidocaine gel for IUD insertion: a randomized control trial.&quot; Contraception. January 2012.</citation>
  </reference>
  <reference>
    <citation>Massey SE, Varady JC, Henzl MR. Pain relief with naproxen following insertion of an intrauterine device. J Reprod Med. 1974 Dec;13(6):226-31. No abstract available.</citation>
    <PMID>4612152</PMID>
  </reference>
  <reference>
    <citation>Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.</citation>
    <PMID>20939159</PMID>
  </reference>
  <reference>
    <citation>O'Connell K, Jones HE, Simon M, Saporta V, Paul M, Lichtenberg ES; National Abortion Federation Members. First-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2009 May;79(5):385-92. doi: 10.1016/j.contraception.2008.11.005. Epub 2008 Dec 11.</citation>
    <PMID>19341852</PMID>
  </reference>
  <reference>
    <citation>Phair N, Jensen JT, Nichols MD. Paracervical block and elective abortion: the effect on pain of waiting between injection and procedure. Am J Obstet Gynecol. 2002 Jun;186(6):1304-7. doi: 10.1067/mob.2002.123734.</citation>
    <PMID>12066113</PMID>
  </reference>
  <reference>
    <citation>Rabin JM, Spitzer M, Dwyer AT, Kaiser IH. Topical anesthesia for gynecologic procedures. Obstet Gynecol. 1989 Jun;73(6):1040-4. doi: 10.1097/00006250-198906000-00027.</citation>
    <PMID>2657523</PMID>
  </reference>
  <reference>
    <citation>Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD006712. doi: 10.1002/14651858.CD006712.pub2.</citation>
    <PMID>19370649</PMID>
  </reference>
  <reference>
    <citation>Roche NE, Li D, James D, Fechner A, Tilak V. The effect of perioperative ketorolac on pain control in pregnancy termination. Contraception. 2012 Mar;85(3):299-303. doi: 10.1016/j.contraception.2011.10.001. Epub 2011 Nov 30.</citation>
    <PMID>22133656</PMID>
  </reference>
  <reference>
    <citation>Wiebe ER, Rawling M. Pain control in abortion. Int J Gynaecol Obstet. 1995 Jul;50(1):41-6. doi: 10.1016/0020-7292(95)02416-a.</citation>
    <PMID>7556858</PMID>
  </reference>
  <reference>
    <citation>Wiebe ER. Comparison of the efficacy of different local anesthetics and techniques of local anesthesia in therapeutic abortions. Am J Obstet Gynecol. 1992 Jul;167(1):131-4. doi: 10.1016/s0002-9378(11)91645-7.</citation>
    <PMID>1442914</PMID>
  </reference>
  <reference>
    <citation>Zieman, Mimi et al. A Pocket Guide to Managing Contraception. The Bridging Gap Foundation. © 2010</citation>
  </reference>
  <reference>
    <citation>Zullo F, Pellicano M, Stigliano CM, Di Carlo C, Fabrizio A, Nappi C. Topical anesthesia for office hysteroscopy. A prospective, randomized study comparing two modalities. J Reprod Med. 1999 Oct;44(10):865-9.</citation>
    <PMID>10554747</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>June 6, 2019</results_first_submitted>
  <results_first_submitted_qc>October 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 1, 2019</results_first_posted>
  <last_update_submitted>October 10, 2019</last_update_submitted>
  <last_update_submitted_qc>October 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Sheila Mody</investigator_full_name>
    <investigator_title>Women's Reproductive Health Research (K12) Scholar</investigator_title>
  </responsible_party>
  <keyword>Contraception</keyword>
  <keyword>Pain</keyword>
  <keyword>Intrauterine Device</keyword>
  <keyword>Paracervical Block</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 11, 2011</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT02219308/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Inclusion: Nulliparous women, 18-45, requesting IUD, seen in our clinic from October 2014 through October 2017 Exclusion: pregnancy, diagnosed chronic pain issues, use of pain medication within 6 hours, misoprostol administration within 24 hours, history of prior IUD placement, known contraindications to IUD placement.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>No Paracervical Block (Sham PCB)</title>
          <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, then receives Sham paracervical block with capped needle.</description>
        </group>
        <group group_id="P2">
          <title>Paracervical Block (PCB)</title>
          <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, then receives paracervical block of 18 mL 1% buffered Lidocaine.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>No Paracervical Block (Sham PCB)</title>
          <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.&#xD;
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.&#xD;
No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride&#xD;
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.&#xD;
IUD placement then proceeds</description>
        </group>
        <group group_id="B2">
          <title>Paracervical Block (PCB)</title>
          <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.&#xD;
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.&#xD;
Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride&#xD;
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.&#xD;
IUD placement then proceeds</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="31"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="64"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.8" spread="3.4"/>
                    <measurement group_id="B2" value="26.1" spread="3.9"/>
                    <measurement group_id="B3" value="25.45" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain With Intrauterine Device (IUD) Placement</title>
        <description>Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.</description>
        <time_frame>Moment of IUD insertion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Paracervical Block (Sham PCB)</title>
            <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.&#xD;
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.&#xD;
No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride&#xD;
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.&#xD;
IUD placement then proceeds</description>
          </group>
          <group group_id="O2">
            <title>Paracervical Block (PCB)</title>
            <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.&#xD;
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.&#xD;
Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride&#xD;
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.&#xD;
IUD placement then proceeds</description>
          </group>
        </group_list>
        <measure>
          <title>Pain With Intrauterine Device (IUD) Placement</title>
          <description>Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.</description>
          <units>mm</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54" lower_limit="33" upper_limit="75"/>
                    <measurement group_id="O2" value="33" lower_limit="10" upper_limit="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Pain Scores for All Time Points</title>
        <description>Distance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes.</description>
        <time_frame>Anticipation of procedure through 5 minutes after IUD placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Paracervical Block (Sham PCB)</title>
            <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.&#xD;
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.&#xD;
No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride&#xD;
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.&#xD;
IUD placement then proceeds</description>
          </group>
          <group group_id="O2">
            <title>Paracervical Block (PCB)</title>
            <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.&#xD;
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.&#xD;
Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride&#xD;
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.&#xD;
IUD placement then proceeds</description>
          </group>
        </group_list>
        <measure>
          <title>Median Pain Scores for All Time Points</title>
          <description>Distance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes.</description>
          <units>mm</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anticipated Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" lower_limit="30" upper_limit="70"/>
                    <measurement group_id="O2" value="58" lower_limit="48" upper_limit="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Speculum Insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="2" upper_limit="20"/>
                    <measurement group_id="O2" value="10" lower_limit="4" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Capped Needle or PCB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="2" upper_limit="20"/>
                    <measurement group_id="O2" value="30" lower_limit="17" upper_limit="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenaculum placement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="4" upper_limit="19"/>
                    <measurement group_id="O2" value="15" lower_limit="6" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uterine Sounding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" lower_limit="24" upper_limit="65"/>
                    <measurement group_id="O2" value="30" lower_limit="8" upper_limit="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IUD placement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54" lower_limit="33" upper_limit="75"/>
                    <measurement group_id="O2" value="33" lower_limit="10" upper_limit="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 mins after IUD placement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" lower_limit="15" upper_limit="50"/>
                    <measurement group_id="O2" value="12" lower_limit="6" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" lower_limit="21" upper_limit="65"/>
                    <measurement group_id="O2" value="30" lower_limit="16" upper_limit="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>IUD insertion procedure: from anticipation of procedure through 5 minutes after IUD placement. Total time approximately 20 minutes.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>No Paracervical Block (Sham PCB)</title>
          <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.&#xD;
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.&#xD;
No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride&#xD;
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.&#xD;
IUD placement then proceeds</description>
        </group>
        <group group_id="E2">
          <title>Paracervical Block (PCB)</title>
          <description>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.&#xD;
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.&#xD;
Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride&#xD;
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.&#xD;
IUD placement then proceeds</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Sheila Mody</name_or_title>
      <organization>University of California, San Diego</organization>
      <phone>858-249-1205</phone>
      <email>smody@ucsd.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02219308
org study id: 141025
nct id: NCT02219308
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intrauterine device (IUD) placement can be painful for patients during and after the
      procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly
      effective long acting reversible contraception. Currently there are no proven effective
      methods for reduction of pain during and after placement of modern IUDs. Paracervical block
      pain may decrease this placement pain.
Modern IUDs are highly effective long acting reversible forms of contraception. The Mirena
      IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing
      pregnancy. Fear of IUD placement can be a barrier to obtaining this highly effective form of
      birth control. The current standard of care for pain management during and after IUD
      placement is no medication, as randomized control trials published to date have limited data
      regarding use of medications to decrease pain. There has been one trial to suggest that the
      use of naproxen with 1% lidocaine paracervical block (PCB) compared to PCB alone may decrease
      pain after IUD placement in primarily nulliparous patients. However, this study was with the
      much wider and no longer available Dalkon Shield IUD. In addition, this study did not show
      any significant decrease in pain scores during IUD placement. Studies to evaluate
      effectiveness of ibuprofen and misoprostol have shown no significant decrease in pain scores
      during and after IUD insertion, although the majority of participants in these studies were
      multiparous. There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion
      may have some decrease in pain, although this study was poorly designed.

      Although there is no standard of care in regards to pain medication administration prior to
      IUD placement, providers often suggest paracervical prior IUD insertion among nulliparous
      women. Therefore the primary aim of this study is to determine whether a paracervical block
      (PCB) decreases pain associated with intrauterine device (IUD) placement compared to no
      paracervical block. We hypothesize that administration of a PCB of 20 mL 1% buffered
      lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual
      analog scale at various time points during IUD placement when compared to no paracervical
      block.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain With Intrauterine Device (IUD) Placement
time frame: Moment of IUD insertion
description: Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.
measure: Median Pain Scores for All Time Points
time frame: Anticipation of procedure through 5 minutes after IUD placement
description: Distance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes.
arm group label: Paracervical Block (PCB)
arm group type: Experimental
description: Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.
arm group label: No Paracervical Block (Sham PCB)
arm group type: Sham Comparator
description: Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.
intervention type: Procedure
intervention name: Paracervical Block (PCB)
description: Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.
IUD placement then proceeds
arm group label: Paracervical Block (PCB)
intervention type: Procedure
intervention name: No Paracervical Block (Sham PCB)
description: Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.
IUD placement then proceeds
arm group label: No Paracervical Block (Sham PCB)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sheila Mody, MD MPH
role: Principal Investigator
affiliation: UCSD
facility: 
facility: 
country: United States
citation: Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.
PMID: 19588429
citation: Cetin A, Cetin M. Effect of deep injections of local anesthetics and basal dilatation of cervix in management of pain during legal abortions. A randomized, controlled study. Contraception. 1997 Aug;56(2):85-7. doi: 10.1016/s0010-7824(97)00096-6.
PMID: 9315416
citation: Edelman AB, Schaefer E, Olson A, Van Houten L, Bednarek P, Leclair C, Jensen JT. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011 Sep;84(3):234-9. doi: 10.1016/j.contraception.2011.01.016. Epub 2011 Mar 3.
PMID: 21843686
citation: Hubacher D, Reyes V, Lillo S, Zepeda A, Chen PL, Croxatto H. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol. 2006 Nov;195(5):1272-7. doi: 10.1016/j.ajog.2006.08.022.
PMID: 17074548
citation: Maguire et al. "Intracervical lidocaine gel for IUD insertion: a randomized control trial." Contraception. January 2012.
citation: Massey SE, Varady JC, Henzl MR. Pain relief with naproxen following insertion of an intrauterine device. J Reprod Med. 1974 Dec;13(6):226-31. No abstract available.
PMID: 4612152
citation: Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.
PMID: 20939159
citation: O'Connell K, Jones HE, Simon M, Saporta V, Paul M, Lichtenberg ES; National Abortion Federation Members. First-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2009 May;79(5):385-92. doi: 10.1016/j.contraception.2008.11.005. Epub 2008 Dec 11.
PMID: 19341852
citation: Phair N, Jensen JT, Nichols MD. Paracervical block and elective abortion: the effect on pain of waiting between injection and procedure. Am J Obstet Gynecol. 2002 Jun;186(6):1304-7. doi: 10.1067/mob.2002.123734.
PMID: 12066113
citation: Rabin JM, Spitzer M, Dwyer AT, Kaiser IH. Topical anesthesia for gynecologic procedures. Obstet Gynecol. 1989 Jun;73(6):1040-4. doi: 10.1097/00006250-198906000-00027.
PMID: 2657523
citation: Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD006712. doi: 10.1002/14651858.CD006712.pub2.
PMID: 19370649
citation: Roche NE, Li D, James D, Fechner A, Tilak V. The effect of perioperative ketorolac on pain control in pregnancy termination. Contraception. 2012 Mar;85(3):299-303. doi: 10.1016/j.contraception.2011.10.001. Epub 2011 Nov 30.
PMID: 22133656
citation: Wiebe ER, Rawling M. Pain control in abortion. Int J Gynaecol Obstet. 1995 Jul;50(1):41-6. doi: 10.1016/0020-7292(95)02416-a.
PMID: 7556858
citation: Wiebe ER. Comparison of the efficacy of different local anesthetics and techniques of local anesthesia in therapeutic abortions. Am J Obstet Gynecol. 1992 Jul;167(1):131-4. doi: 10.1016/s0002-9378(11)91645-7.
PMID: 1442914
citation: Zieman, Mimi et al. A Pocket Guide to Managing Contraception. The Bridging Gap Foundation. © 2010
citation: Zullo F, Pellicano M, Stigliano CM, Di Carlo C, Fabrizio A, Nappi C. Topical anesthesia for office hysteroscopy. A prospective, randomized study comparing two modalities. J Reprod Med. 1999 Oct;44(10):865-9.
PMID: 10554747
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Sheila Mody
investigator title: Women's Reproductive Health Research (K12) Scholar
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 