<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/NCT02264795</url>
  </required_header>
  <id_info>
    <org_study_id>14-04</org_study_id>
    <nct_id>NCT02264795</nct_id>
  </id_info>
  <brief_title>Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia?</brief_title>
  <official_title>Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia? A Randomized, Double-blind, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The instillation of local anesthetic into the peritoneum has been found to be safe and&#xD;
      effective in reducing postoperative pain and morphine consumption after abdominal surgery. A&#xD;
      review of studies reporting serum levels of local anesthetic after intraperitoneal delivery&#xD;
      found no cases of clinical toxicity in any of the trials. The studies in this meta-analysis&#xD;
      did not include post-cesarean delivery pain and there is a lack of data to support the use of&#xD;
      intraperitoneal local anesthetic after cesarean section.&#xD;
&#xD;
      The purpose of this study is to assess the efficacy of intraperitoneal lidocaine on&#xD;
      postoperative pain scores after cesarean delivery. This study will compare a 20ml solution of&#xD;
      lidocaine (400mg) with epinephrine 5mcg/ml versus normal saline (placebo) instilled into the&#xD;
      peritoneum at the end of surgery in women undergoing cesarean delivery. The investigators&#xD;
      hypothesize that intraperitoneal lidocaine will result in lower pain scores, reduce opioid&#xD;
      consumption and opioid related side effects, and higher maternal satisfaction after cesarean&#xD;
      delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain after cesarean delivery can have a significant negative impact on the&#xD;
      mother's ability to care for her newborn and lead to complications such as thromboembolism,&#xD;
      chronic pain, and depression. Postoperative analgesia for cesarean delivery has undergone&#xD;
      remarkable improvement and is currently based on a multimodal approach to improve pain&#xD;
      control and reduce the systemic complications of opiates. Despite this some patients still&#xD;
      experience moderate to severe pain after cesarean delivery, and further strategies to improve&#xD;
      analgesia and postoperative recovery are warranted.&#xD;
&#xD;
      The use of intraperitoneal local anesthetics to reduce postoperative pain has been studied in&#xD;
      a variety of surgical settings, such as hysterectomy, laparoscopic cholecystectomy and minor&#xD;
      laparoscopic gynecological procedures. These studies have compared different local&#xD;
      anesthetics and the timing of local anesthetic delivery in relation to surgery, for example&#xD;
      pre-procedure, at the end of surgery or via continuous catheter infusion. Intraperitoneal&#xD;
      lidocaine at the end of surgery was associated with lower postoperative pain scores after&#xD;
      total abdominal hysterectomy (200mg lidocaine) and laparoscopic cholecystectomy (400mg&#xD;
      lidocaine). There is a large growing body of evidence to support the use of intraperitoneal&#xD;
      local anesthetic to reduce postoperative pain. However, there is a lack of data to support&#xD;
      its use in postcesarean delivery pain. The investigators found one study reporting a&#xD;
      decreased incidence of postoperative pain following intraperitoneal lidocaine instillation at&#xD;
      the end of cesarean delivery, in which the parietal peritoneum had been sutured.&#xD;
&#xD;
      The purpose of this study is to evaluate the efficacy of intraperitoneal lidocaine 400mg&#xD;
      instillation at the end of cesarean delivery on maternal pain scores and satisfaction, in the&#xD;
      context of a multimodal analgesic regimen inclusive of intrathecal opioids and systemic&#xD;
      NSAIDs, acetaminophen and opioids. The investigators hypothesize that intraperitoneal&#xD;
      lidocaine will decrease VAS pain scores, reduce opioid consumption and opioid related side&#xD;
      effects, and increase maternal satisfaction after cesarean delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Score (VAS) 24hr movement</measure>
    <time_frame>24 hours</time_frame>
    <description>VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours postcesarean delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety score before surgery (VAS)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Maternal anxiety score before surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score (VAS) 2hr rest</measure>
    <time_frame>2 hours</time_frame>
    <description>VAS score (VAS 0-100 mm) for maternal pain at rest at 2 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score (VAS) 2hr movement</measure>
    <time_frame>2 hours</time_frame>
    <description>VAS score (VAS 0-100 mm) for maternal pain on movement at 2 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score (VAS) 24hr rest</measure>
    <time_frame>24 hours</time_frame>
    <description>VAS score (VAS 0-100 mm) for maternal pain at rest at 24 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score (VAS) 48hr rest</measure>
    <time_frame>48 hours</time_frame>
    <description>VAS score (VAS 0-100 mm) for maternal pain at rest at 48 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score (VAS) 48hr movement</measure>
    <time_frame>48 hours</time_frame>
    <description>VAS score (VAS 0-100 mm) for maternal pain on movement at 48 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction 2hr</measure>
    <time_frame>2 hours</time_frame>
    <description>Patient satisfaction at 2 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction 24hr</measure>
    <time_frame>24 hours</time_frame>
    <description>Patient satisfaction at 24 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction 48hr</measure>
    <time_frame>48 hours</time_frame>
    <description>Patient satisfaction at 48 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opiate consumption PACU</measure>
    <time_frame>2 hours</time_frame>
    <description>Opiate consumption on discharge from PACU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opiate consumption 24hrs</measure>
    <time_frame>24 hours</time_frame>
    <description>Opiate consumption within 24 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opiate consumption 48hrs</measure>
    <time_frame>48 hours</time_frame>
    <description>Opiate consumption within 48 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side Effect scores</measure>
    <time_frame>48 hours</time_frame>
    <description>Nausea, vomiting and pruritis scores on discharge from PACU, at 24 hours and 48 hours postcesarean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel function</measure>
    <time_frame>48 hours</time_frame>
    <description>Return of bowel function as assessed by passing flatus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to request for first opiate</measure>
    <time_frame>48 hours</time_frame>
    <description>Hours to request for first opiate (if any) postcesarean</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intraperitoneal instillation of normal saline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intraperitoneal instillation lidocaine 2% (400mg) with epinephrine 5mcg/ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Lidocaine 2% with epinephrine 5mcg/ml</description>
    <arm_group_label>Lidocaine</arm_group_label>
    <other_name>Lidocaine HCl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.9% Sodium Chloride Solution</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I or II patients&#xD;
&#xD;
          -  18-50 years of age&#xD;
&#xD;
          -  Term pregnancy&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Spinal anesthetic&#xD;
&#xD;
          -  Pfannenstiel incision&#xD;
&#xD;
          -  Patients who have given pre-operative informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse or are unable to give consent&#xD;
&#xD;
          -  ASA &gt;2&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Chronic pain&#xD;
&#xD;
          -  BMI &gt;40&#xD;
&#xD;
          -  Contraindication to acetaminophen or non-steroidal anti-inflammatory drugs&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naveed Siddiqui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>May 2, 2016</last_update_submitted>
  <last_update_submitted_qc>May 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cesarean section</keyword>
  <keyword>Lidocaine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02264795
org study id: 14-04
nct id: NCT02264795
lead sponsor: 
has dmc: No
The instillation of local anesthetic into the peritoneum has been found to be safe and
      effective in reducing postoperative pain and morphine consumption after abdominal surgery. A
      review of studies reporting serum levels of local anesthetic after intraperitoneal delivery
      found no cases of clinical toxicity in any of the trials. The studies in this meta-analysis
      did not include post-cesarean delivery pain and there is a lack of data to support the use of
      intraperitoneal local anesthetic after cesarean section.

      The purpose of this study is to assess the efficacy of intraperitoneal lidocaine on
      postoperative pain scores after cesarean delivery. This study will compare a 20ml solution of
      lidocaine (400mg) with epinephrine 5mcg/ml versus normal saline (placebo) instilled into the
      peritoneum at the end of surgery in women undergoing cesarean delivery. The investigators
      hypothesize that intraperitoneal lidocaine will result in lower pain scores, reduce opioid
      consumption and opioid related side effects, and higher maternal satisfaction after cesarean
      delivery.
Postoperative pain after cesarean delivery can have a significant negative impact on the
      mother's ability to care for her newborn and lead to complications such as thromboembolism,
      chronic pain, and depression. Postoperative analgesia for cesarean delivery has undergone
      remarkable improvement and is currently based on a multimodal approach to improve pain
      control and reduce the systemic complications of opiates. Despite this some patients still
      experience moderate to severe pain after cesarean delivery, and further strategies to improve
      analgesia and postoperative recovery are warranted.

      The use of intraperitoneal local anesthetics to reduce postoperative pain has been studied in
      a variety of surgical settings, such as hysterectomy, laparoscopic cholecystectomy and minor
      laparoscopic gynecological procedures. These studies have compared different local
      anesthetics and the timing of local anesthetic delivery in relation to surgery, for example
      pre-procedure, at the end of surgery or via continuous catheter infusion. Intraperitoneal
      lidocaine at the end of surgery was associated with lower postoperative pain scores after
      total abdominal hysterectomy (200mg lidocaine) and laparoscopic cholecystectomy (400mg
      lidocaine). There is a large growing body of evidence to support the use of intraperitoneal
      local anesthetic to reduce postoperative pain. However, there is a lack of data to support
      its use in postcesarean delivery pain. The investigators found one study reporting a
      decreased incidence of postoperative pain following intraperitoneal lidocaine instillation at
      the end of cesarean delivery, in which the parietal peritoneum had been sutured.

      The purpose of this study is to evaluate the efficacy of intraperitoneal lidocaine 400mg
      instillation at the end of cesarean delivery on maternal pain scores and satisfaction, in the
      context of a multimodal analgesic regimen inclusive of intrathecal opioids and systemic
      NSAIDs, acetaminophen and opioids. The investigators hypothesize that intraperitoneal
      lidocaine will decrease VAS pain scores, reduce opioid consumption and opioid related side
      effects, and increase maternal satisfaction after cesarean delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain Score (VAS) 24hr movement
time frame: 24 hours
description: VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours postcesarean delivery
measure: Anxiety score before surgery (VAS)
time frame: 5 minutes
description: Maternal anxiety score before surgery
measure: Pain score (VAS) 2hr rest
time frame: 2 hours
description: VAS score (VAS 0-100 mm) for maternal pain at rest at 2 hours postcesarean
measure: Pain score (VAS) 2hr movement
time frame: 2 hours
description: VAS score (VAS 0-100 mm) for maternal pain on movement at 2 hours postcesarean
measure: Pain Score (VAS) 24hr rest
time frame: 24 hours
description: VAS score (VAS 0-100 mm) for maternal pain at rest at 24 hours postcesarean
measure: Pain Score (VAS) 48hr rest
time frame: 48 hours
description: VAS score (VAS 0-100 mm) for maternal pain at rest at 48 hours postcesarean
measure: Pain Score (VAS) 48hr movement
time frame: 48 hours
description: VAS score (VAS 0-100 mm) for maternal pain on movement at 48 hours postcesarean
measure: Patient satisfaction 2hr
time frame: 2 hours
description: Patient satisfaction at 2 hours postcesarean
measure: Patient satisfaction 24hr
time frame: 24 hours
description: Patient satisfaction at 24 hours postcesarean
measure: Patient satisfaction 48hr
time frame: 48 hours
description: Patient satisfaction at 48 hours postcesarean
measure: Opiate consumption PACU
time frame: 2 hours
description: Opiate consumption on discharge from PACU
measure: Opiate consumption 24hrs
time frame: 24 hours
description: Opiate consumption within 24 hours postcesarean
measure: Opiate consumption 48hrs
time frame: 48 hours
description: Opiate consumption within 48 hours postcesarean
measure: Side Effect scores
time frame: 48 hours
description: Nausea, vomiting and pruritis scores on discharge from PACU, at 24 hours and 48 hours postcesarean
measure: Bowel function
time frame: 48 hours
description: Return of bowel function as assessed by passing flatus
measure: Time to request for first opiate
time frame: 48 hours
description: Hours to request for first opiate (if any) postcesarean
arm group label: Placebo
arm group type: Placebo Comparator
description: Intraperitoneal instillation of normal saline.
arm group label: Lidocaine
arm group type: Active Comparator
description: Intraperitoneal instillation lidocaine 2% (400mg) with epinephrine 5mcg/ml.
intervention type: Drug
intervention name: Lidocaine
description: Lidocaine 2% with epinephrine 5mcg/ml
arm group label: Lidocaine
other name: Lidocaine HCl
intervention type: Drug
intervention name: Placebo
description: 0.9% Sodium Chloride Solution
arm group label: Placebo
other name: Normal saline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naveed Siddiqui, MD
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Lidocaine