<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/NCT02257346</url>
  </required_header>
  <id_info>
    <org_study_id>Lidocaine-RCT</org_study_id>
    <nct_id>NCT02257346</nct_id>
  </id_info>
  <brief_title>Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery</brief_title>
  <official_title>The Effect of Perioperative Systemic Lidocaine on Quality of Recovery After Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      When given intravenously, the local anesthetic lidocaine has been shown to decrease the&#xD;
      amount of pain medication patients require when recovering from several types of surgeries.&#xD;
      Cesarean delivery is a very common surgery in the United States, effecting more than 1&#xD;
      million women each year. The investigators hypothesize that lidocaine, given during and&#xD;
      immediately after a patient undergoes a cesarean section, will help improve a mother's&#xD;
      overall recovery experience, as well as positively influence bonding with her new baby.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain after Cesarean delivery is a common occurrence on the labor and delivery unit. The&#xD;
      increased use of neuraxial anesthesia has allowed the administration of neuraxial opioids to&#xD;
      help with postoperative pain control. Many patients, however, still require IV and oral&#xD;
      opioids in the post anesthesia recovery unit (PACU), and on the postpartum nursing floor.&#xD;
      Post Cesarean delivery pain not only has the usual adverse effects common to all&#xD;
      postoperative pain (i.e. increased risk for deep vein thrombosis, pulmonary embolism,&#xD;
      coronary ischemia, pneumonia, poor wound healing, and psychological dysfunction) but also has&#xD;
      the potential to adversely affect mother-baby bonding, time spent in skin-to-skin contact and&#xD;
      success of initiating effective breastfeeding.&#xD;
&#xD;
      Systemic administration of lidocaine has been shown to decrease opioid consumption, improve&#xD;
      recovery of bowel function and promote a better recovery after inpatient procedures.&#xD;
      Lidocaine has been shown to have analgesic, antihyperalgesic and anti-inflammatory&#xD;
      properties. It also has an excellent safety profile when given by a low-dose infusion.&#xD;
&#xD;
      Assessing a patient's quality of recovery has become an important outcome in several studies.&#xD;
      The patient's capacity to return to her normal activities and effectively care for her&#xD;
      newborn is one of the most important signs of a successful surgical procedure, and it has&#xD;
      significant economic, sociological and psychological implications.&#xD;
&#xD;
      Quality of recovery -40(QoR-40) is a validated 40-item instrument to assess the quality of&#xD;
      post-operative recovery (10). Myles et al. have concluded that the QoR-40 would be a useful&#xD;
      outcome measure to assess the impact on changes in health care delivery, but anesthesia&#xD;
      studies underutilize this instrument.&#xD;
&#xD;
      This study will evaluate the effect of perioperative systemic lidocaine in the postoperative&#xD;
      quality of recovery of patients undergoing Cesarean delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI terminated study with no subjects enrolled.&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2014</start_date>
  <completion_date type="Actual">February 15, 2015</completion_date>
  <primary_completion_date type="Actual">February 15, 2015</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Recovery 40 on the day after surgery</measure>
    <time_frame>1 day</time_frame>
    <description>The quality of recovery 40 (QoR-40) is a validated questionnaire used to assess several variables that effect a patient's post-operative experience.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>1 day</time_frame>
    <description>Total opioid consumption for the first 24 hours after delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin-to-skin time</measure>
    <time_frame>1 day</time_frame>
    <description>Percentage of time a patient spends in skin to skin contact with their newborn in the first 24 hours.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous lidocaine 1.5 mg/Kg bolus dose and 2mg/Kg/hr infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous normal saline infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Lidocaine infusion will be administered immediately after delivery of the fetus and continue through 1 hour into recovery period.</description>
    <arm_group_label>Lidocaine</arm_group_label>
    <other_name>Xylocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Normal Saline will be administered as a placebo immediately after delivery of the fetus and continue through 1 hour into recovery period</description>
    <arm_group_label>Normal Saline</arm_group_label>
    <other_name>0.9% Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists Class II&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Scheduled Cesarean delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Chronic opioid use&#xD;
&#xD;
          -  Greater than 2 prior cesarean deliveries&#xD;
&#xD;
          -  Prior myomectomy&#xD;
&#xD;
          -  Prior classical cesarean incision&#xD;
&#xD;
          -  BMI greater than 40&#xD;
&#xD;
          -  History of cardiac disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason R Farrer, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NorthwesternUniversity</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bramson L, Lee JW, Moore E, Montgomery S, Neish C, Bahjri K, Melcher CL. Effect of early skin-to-skin mother--infant contact during the first 3 hours following birth on exclusive breastfeeding during the maternity hospital stay. J Hum Lact. 2010 May;26(2):130-7. doi: 10.1177/0890334409355779. Epub 2010 Jan 28.</citation>
    <PMID>20110561</PMID>
  </reference>
  <reference>
    <citation>Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.</citation>
    <PMID>15041597</PMID>
  </reference>
  <reference>
    <citation>Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.</citation>
    <PMID>9459225</PMID>
  </reference>
  <reference>
    <citation>Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.</citation>
    <PMID>17197840</PMID>
  </reference>
  <reference>
    <citation>Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.</citation>
    <PMID>18844267</PMID>
  </reference>
  <reference>
    <citation>Gill TM, Feinstein AR. A critical appraisal of the quality of quality-of-life measurements. JAMA. 1994 Aug 24-31;272(8):619-26.</citation>
    <PMID>7726894</PMID>
  </reference>
  <reference>
    <citation>Guyatt GH, Cook DJ. Health status, quality of life, and the individual. JAMA. 1994 Aug 24-31;272(8):630-1. No abstract available.</citation>
    <PMID>8057520</PMID>
  </reference>
  <reference>
    <citation>Watcha MF, Issioui T, Klein KW, White PF. Costs and effectiveness of rofecoxib, celecoxib, and acetaminophen for preventing pain after ambulatory otolaryngologic surgery. Anesth Analg. 2003 Apr;96(4):987-994. doi: 10.1213/01.ANE.0000053255.93270.31.</citation>
    <PMID>12651647</PMID>
  </reference>
  <reference>
    <citation>Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.</citation>
    <PMID>9895071</PMID>
  </reference>
  <reference>
    <citation>Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.</citation>
    <PMID>10740540</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>June 7, 2022</last_update_submitted>
  <last_update_submitted_qc>June 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Jason Farrer</investigator_full_name>
    <investigator_title>Clinical Instructor</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Lidocaine</keyword>
  <keyword>Quality</keyword>
  <keyword>Recovery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02257346
org study id: Lidocaine-RCT
nct id: NCT02257346
lead sponsor: 
has dmc: No
When given intravenously, the local anesthetic lidocaine has been shown to decrease the
      amount of pain medication patients require when recovering from several types of surgeries.
      Cesarean delivery is a very common surgery in the United States, effecting more than 1
      million women each year. The investigators hypothesize that lidocaine, given during and
      immediately after a patient undergoes a cesarean section, will help improve a mother's
      overall recovery experience, as well as positively influence bonding with her new baby.
Pain after Cesarean delivery is a common occurrence on the labor and delivery unit. The
      increased use of neuraxial anesthesia has allowed the administration of neuraxial opioids to
      help with postoperative pain control. Many patients, however, still require IV and oral
      opioids in the post anesthesia recovery unit (PACU), and on the postpartum nursing floor.
      Post Cesarean delivery pain not only has the usual adverse effects common to all
      postoperative pain (i.e. increased risk for deep vein thrombosis, pulmonary embolism,
      coronary ischemia, pneumonia, poor wound healing, and psychological dysfunction) but also has
      the potential to adversely affect mother-baby bonding, time spent in skin-to-skin contact and
      success of initiating effective breastfeeding.

      Systemic administration of lidocaine has been shown to decrease opioid consumption, improve
      recovery of bowel function and promote a better recovery after inpatient procedures.
      Lidocaine has been shown to have analgesic, antihyperalgesic and anti-inflammatory
      properties. It also has an excellent safety profile when given by a low-dose infusion.

      Assessing a patient's quality of recovery has become an important outcome in several studies.
      The patient's capacity to return to her normal activities and effectively care for her
      newborn is one of the most important signs of a successful surgical procedure, and it has
      significant economic, sociological and psychological implications.

      Quality of recovery -40(QoR-40) is a validated 40-item instrument to assess the quality of
      post-operative recovery (10). Myles et al. have concluded that the QoR-40 would be a useful
      outcome measure to assess the impact on changes in health care delivery, but anesthesia
      studies underutilize this instrument.

      This study will evaluate the effect of perioperative systemic lidocaine in the postoperative
      quality of recovery of patients undergoing Cesarean delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Quality of Recovery 40 on the day after surgery
time frame: 1 day
description: The quality of recovery 40 (QoR-40) is a validated questionnaire used to assess several variables that effect a patient's post-operative experience.
measure: Opioid consumption
time frame: 1 day
description: Total opioid consumption for the first 24 hours after delivery
measure: Skin-to-skin time
time frame: 1 day
description: Percentage of time a patient spends in skin to skin contact with their newborn in the first 24 hours.
arm group label: Lidocaine
arm group type: Active Comparator
description: Intravenous lidocaine 1.5 mg/Kg bolus dose and 2mg/Kg/hr infusion
arm group label: Normal Saline
arm group type: Placebo Comparator
description: Intravenous normal saline infusion
intervention type: Drug
intervention name: Lidocaine
description: Lidocaine infusion will be administered immediately after delivery of the fetus and continue through 1 hour into recovery period.
arm group label: Lidocaine
other name: Xylocaine
intervention type: Drug
intervention name: Normal Saline
description: Normal Saline will be administered as a placebo immediately after delivery of the fetus and continue through 1 hour into recovery period
arm group label: Normal Saline
other name: 0.9% Saline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason R Farrer, M.D.
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
citation: Bramson L, Lee JW, Moore E, Montgomery S, Neish C, Bahjri K, Melcher CL. Effect of early skin-to-skin mother--infant contact during the first 3 hours following birth on exclusive breastfeeding during the maternity hospital stay. J Hum Lact. 2010 May;26(2):130-7. doi: 10.1177/0890334409355779. Epub 2010 Jan 28.
PMID: 20110561
citation: Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.
PMID: 15041597
citation: Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
PMID: 9459225
citation: Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
PMID: 17197840
citation: Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.
PMID: 18844267
citation: Gill TM, Feinstein AR. A critical appraisal of the quality of quality-of-life measurements. JAMA. 1994 Aug 24-31;272(8):619-26.
PMID: 7726894
citation: Guyatt GH, Cook DJ. Health status, quality of life, and the individual. JAMA. 1994 Aug 24-31;272(8):630-1. No abstract available.
PMID: 8057520
citation: Watcha MF, Issioui T, Klein KW, White PF. Costs and effectiveness of rofecoxib, celecoxib, and acetaminophen for preventing pain after ambulatory otolaryngologic surgery. Anesth Analg. 2003 Apr;96(4):987-994. doi: 10.1213/01.ANE.0000053255.93270.31.
PMID: 12651647
citation: Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.
PMID: 9895071
citation: Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PMID: 10740540
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Jason Farrer
investigator title: Clinical Instructor
mesh term: Lidocaine
sharing ipd: No