<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/NCT03261193</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16120234</org_study_id>
    <nct_id>NCT03261193</nct_id>
  </id_info>
  <brief_title>ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain</brief_title>
  <acronym>qlcsection</acronym>
  <official_title>QL Block for Post-cesarean Delivery Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nicholas Schott</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of standard post-operative cesarean surgery pain management with regional post-op&#xD;
      pain control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy&#xD;
      that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal&#xD;
      post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide&#xD;
      superior post-cesarean analgesia compared to the current standard of care, multi-modal&#xD;
      analgesia.&#xD;
&#xD;
      Thus, analgesia following cesarean section using QLB compared to the current standard of care&#xD;
      alone will be further investigated. Current practice for cesarean surgical intervention&#xD;
      consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled&#xD;
      post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for&#xD;
      breakthrough pain).&#xD;
&#xD;
      Investigators will measure side-effects associated with each strategy: Standard of care&#xD;
      methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in&#xD;
      conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The&#xD;
      experimental treatment arm will entail standard of care in addition to QLB. The sham&#xD;
      comparator will entail standard of care in addition to QLB with saline.&#xD;
&#xD;
      For each strategy, we will measure and model associated economic ramifications; such factors&#xD;
      will include drug costs, procedure costs, and costs associated with length of stay and&#xD;
      re-admissions.&#xD;
&#xD;
      The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block,&#xD;
      but differs slightly in regards to the anatomical region where local anesthetic is injected.&#xD;
      Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers&#xD;
      greater safety due to enhanced visualization. The TAP block has been studied extensively for&#xD;
      post-cesarean delivery pain, consistently showing that it is not superior to ITM for&#xD;
      post-operative analgesia; however, it may prove to be helpful in patients with breakthrough&#xD;
      pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general&#xD;
      anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to&#xD;
      TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased&#xD;
      risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically&#xD;
      using the QLB for postoperative pain after cesarean delivery. In this study, they compared a&#xD;
      true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB&#xD;
      provided improved pain control and decreased the need for post-operative opioids. Another&#xD;
      study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing&#xD;
      post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM&#xD;
      (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).&#xD;
&#xD;
      The gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach&#xD;
      including ITM for cesarean section warrants further investigation. Clinicians are constantly&#xD;
      searching for methods to provide patients with the most effective medical interventions that&#xD;
      provide maximal benefit and minimal harm. Post-operative pain control following cesarean&#xD;
      delivery is an area that is important to patients and to providers, and the introduction of&#xD;
      the QLB for this purpose has the potential to improve analgesic benefit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>Phase 3</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>VAS pain score with movement</measure>
    <time_frame>24 hours after surgical procedure (cesarean delivery)</time_frame>
    <description>Post-operative pain accompanied with patient movement will be measured using a 10 point pain scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breast feeding success/quality</measure>
    <time_frame>12, 24 and 36 hours post-operatively</time_frame>
    <description>Limited breastfeeding resulting from pain or opioid side effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS pain score at rest</measure>
    <time_frame>At baseline (PACU entry) and 1, 4, 24 and 48 hours after intervention</time_frame>
    <description>VAS pain score reported by the patient at rest post-operatively using a 10 point pain scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First request for pain medication</measure>
    <time_frame>From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours</time_frame>
    <description>Time to first request for as desired (PRN) oral or parenteral opioid medication will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation</measure>
    <time_frame>From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours</time_frame>
    <description>Presence or absence will be noted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritis</measure>
    <time_frame>From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours</time_frame>
    <description>Presence or absence will be noted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea</measure>
    <time_frame>From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours</time_frame>
    <description>Presence or absence will be noted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emesis</measure>
    <time_frame>From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours</time_frame>
    <description>Presence or absence will be noted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours</time_frame>
    <description>Will be measured in beats/minute (BPM) per standard of care and documented by study staff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthetic toxicity</measure>
    <time_frame>15 min, 30 min, 45 min, 1 hour, and 4 hours post-operatively</time_frame>
    <description>symptoms indicating this event such as perioral numbness, ringing in the ears or metallic taste in the mouth will be noted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours</time_frame>
    <description>Will be measured in mmHG per standard of care and documented by study staff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Rate</measure>
    <time_frame>From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours</time_frame>
    <description>Will be measured in rate/min per standard of care and documented by study staff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation</measure>
    <time_frame>From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours</time_frame>
    <description>Will be measured in % per standard of care and documented by study staff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-Item Short Form Survey (SF-36)</measure>
    <time_frame>48-hours post-operatively</time_frame>
    <description>Quality of life measures will be assessed using the SF-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) - Short Form</measure>
    <time_frame>6-weeks post operatively</time_frame>
    <description>Severity of pain and its impact on functioning using BPI Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Postnatal Depression Scale (EPDS)</measure>
    <time_frame>6-weeks post operatively</time_frame>
    <description>Possible symptoms of depression in the postnatal period will be assessed via EPDS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic Pain Visual Analogue scale</measure>
    <time_frame>6-weeks postoperatively</time_frame>
    <description>Pain score reported by the patient at rest using the VAS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid use</measure>
    <time_frame>From post-operative until 36 hours and at 6-weeks postoperatively or until the patient is discharged or withdrawn from study</time_frame>
    <description>Total opioid consumption post-operative</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>ITM + Sham QLB</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ITM + Bupivacaine QLB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ITM + Sham QLB</intervention_name>
    <description>Sham subcutaneous non-anesthetic infiltration with saline</description>
    <arm_group_label>ITM + Sham QLB</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ITM + Bupivacaine QLB</intervention_name>
    <description>QL plane block with local anesthesia</description>
    <arm_group_label>ITM + Bupivacaine QLB</arm_group_label>
    <other_name>Bupivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective cesarean planned under spinal anesthesia&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification score of 2 (or less)&#xD;
&#xD;
          -  Gestational age of at least 37 weeks&#xD;
&#xD;
          -  Intention to breastfeed infant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to neuraxial blockade (such as clinically relevant coagulopathy,&#xD;
             recent anticoagulant use, patient refusal, or localized skin infection overlying the&#xD;
             site of needle entry)&#xD;
&#xD;
          -  Anatomical abnormalities contraindicating spinal or QLB placement&#xD;
&#xD;
          -  Received/Conversion to general anesthesia&#xD;
&#xD;
          -  Received supplemental parenteral anesthesia (sedation) for any reason (e.g.&#xD;
             unanticipated prolonged surgical procedure)&#xD;
&#xD;
          -  History of chronic pain&#xD;
&#xD;
          -  History of chronic opioid use/abuse&#xD;
&#xD;
          -  History of Subutex, methadone, other maintenance therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnancy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Monroe</last_name>
    <role>Study Director</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicholas Schott</last_name>
    <phone>7168807034</phone>
    <email>schottnj@upmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stephanie Nam</last_name>
    <email>nams@upmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Magee Women's Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>June 2, 2022</last_update_submitted>
  <last_update_submitted_qc>June 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Nicholas Schott</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>quadratus lumborum block</keyword>
  <keyword>post-operative pain</keyword>
  <keyword>cesarean section pain</keyword>
  <keyword>analgesia</keyword>
  <keyword>nerve block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans to share</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>August 17, 2023</submitted>
    <returned>September 13, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03261193
org study id: PRO16120234
nct id: NCT03261193
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Comparison of standard post-operative cesarean surgery pain management with regional post-op
      pain control.
The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy
      that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal
      post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide
      superior post-cesarean analgesia compared to the current standard of care, multi-modal
      analgesia.

      Thus, analgesia following cesarean section using QLB compared to the current standard of care
      alone will be further investigated. Current practice for cesarean surgical intervention
      consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled
      post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for
      breakthrough pain).

      Investigators will measure side-effects associated with each strategy: Standard of care
      methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in
      conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The
      experimental treatment arm will entail standard of care in addition to QLB. The sham
      comparator will entail standard of care in addition to QLB with saline.

      For each strategy, we will measure and model associated economic ramifications; such factors
      will include drug costs, procedure costs, and costs associated with length of stay and
      re-admissions.

      The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block,
      but differs slightly in regards to the anatomical region where local anesthetic is injected.
      Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers
      greater safety due to enhanced visualization. The TAP block has been studied extensively for
      post-cesarean delivery pain, consistently showing that it is not superior to ITM for
      post-operative analgesia; however, it may prove to be helpful in patients with breakthrough
      pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general
      anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to
      TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased
      risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically
      using the QLB for postoperative pain after cesarean delivery. In this study, they compared a
      true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB
      provided improved pain control and decreased the need for post-operative opioids. Another
      study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing
      post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM
      (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).

      The gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach
      including ITM for cesarean section warrants further investigation. Clinicians are constantly
      searching for methods to provide patients with the most effective medical interventions that
      provide maximal benefit and minimal harm. Post-operative pain control following cesarean
      delivery is an area that is important to patients and to providers, and the introduction of
      the QLB for this purpose has the potential to improve analgesic benefit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: VAS pain score with movement
time frame: 24 hours after surgical procedure (cesarean delivery)
description: Post-operative pain accompanied with patient movement will be measured using a 10 point pain scale (VAS)
measure: Breast feeding success/quality
time frame: 12, 24 and 36 hours post-operatively
description: Limited breastfeeding resulting from pain or opioid side effects
measure: VAS pain score at rest
time frame: At baseline (PACU entry) and 1, 4, 24 and 48 hours after intervention
description: VAS pain score reported by the patient at rest post-operatively using a 10 point pain scale (VAS)
measure: First request for pain medication
time frame: From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours
description: Time to first request for as desired (PRN) oral or parenteral opioid medication will be assessed
measure: Sedation
time frame: From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours
description: Presence or absence will be noted
measure: Pruritis
time frame: From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours
description: Presence or absence will be noted
measure: Nausea
time frame: From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours
description: Presence or absence will be noted
measure: Emesis
time frame: From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours
description: Presence or absence will be noted
measure: Heart Rate
time frame: From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours
description: Will be measured in beats/minute (BPM) per standard of care and documented by study staff
measure: Anesthetic toxicity
time frame: 15 min, 30 min, 45 min, 1 hour, and 4 hours post-operatively
description: symptoms indicating this event such as perioral numbness, ringing in the ears or metallic taste in the mouth will be noted
measure: Blood pressure
time frame: From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours
description: Will be measured in mmHG per standard of care and documented by study staff
measure: Respiratory Rate
time frame: From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours
description: Will be measured in rate/min per standard of care and documented by study staff
measure: Oxygen Saturation
time frame: From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours
description: Will be measured in % per standard of care and documented by study staff
measure: 36-Item Short Form Survey (SF-36)
time frame: 48-hours post-operatively
description: Quality of life measures will be assessed using the SF-36
measure: Brief Pain Inventory (BPI) - Short Form
time frame: 6-weeks post operatively
description: Severity of pain and its impact on functioning using BPI Short Form
measure: Edinburgh Postnatal Depression Scale (EPDS)
time frame: 6-weeks post operatively
description: Possible symptoms of depression in the postnatal period will be assessed via EPDS
measure: Dynamic Pain Visual Analogue scale
time frame: 6-weeks postoperatively
description: Pain score reported by the patient at rest using the VAS scale
measure: Opioid use
time frame: From post-operative until 36 hours and at 6-weeks postoperatively or until the patient is discharged or withdrawn from study
description: Total opioid consumption post-operative
arm group label: ITM + Sham QLB
arm group type: Sham Comparator
description: Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
arm group label: ITM + Bupivacaine QLB
arm group type: Experimental
description: Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
intervention type: Drug
intervention name: ITM + Sham QLB
description: Sham subcutaneous non-anesthetic infiltration with saline
arm group label: ITM + Sham QLB
other name: Saline
intervention type: Drug
intervention name: ITM + Bupivacaine QLB
description: QL plane block with local anesthesia
arm group label: ITM + Bupivacaine QLB
other name: Bupivacaine
criteria: 
gender: Female
gender based: Yes
gender description: pregnancy
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Amy Monroe
role: Study Director
affiliation: University of Pittsburgh
last name: Nicholas Schott
phone: 7168807034
email: schottnj@upmc.edu
last name: Stephanie Nam
email: nams@upmc.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Nicholas Schott
investigator title: Anesthesiologist
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No
ipd description: No plans to share
submitted: August 17, 2023
returned: September 13, 2023