<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/NCT01720433</url>
  </required_header>
  <id_info>
    <org_study_id>lap pain trial NGH</org_study_id>
    <nct_id>NCT01720433</nct_id>
  </id_info>
  <brief_title>Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial</brief_title>
  <official_title>Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northampton General Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northampton General Hospital NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as&#xD;
      causes of post-operative morbidity. This prospective, double-blind, randomized controlled&#xD;
      trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by&#xD;
      implementing a simple intra-operative technique.&#xD;
&#xD;
      Patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or&#xD;
      laparoscopic inguinal hernia repair will be recruited to the trial. Patients will be&#xD;
      randomized to either the current standard (control group) or to receive an intervention to&#xD;
      remove residual CO2. In the intervention group the pneumo-peritoneum will be removed, at the&#xD;
      end of the operation, by placing the patient in the Trendelenburg position and utilising a&#xD;
      pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of&#xD;
      60 cm H2O. In the control group residual pneumo-peritoneum will be evacuated at the end of&#xD;
      the procedure by passive decompression via the open operative ports.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial recruited 76 randomly assigned patients, 37 in the intervention group and 39 in&#xD;
      the control group. The overall post-surgery pain scores, as analysed by two-way ANOVA, were&#xD;
      significantly lower in the intervention group (P=0.0019). On Bonferroni post-tests both 12&#xD;
      hour (P&lt;0.01) and 24-hour (P&lt;0.01) pain scores were significantly lower in the intervention&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain scores at varying time points pot operatively</measure>
    <time_frame>48 hours</time_frame>
    <description>Pain scores were assessed by the use of a validated visual analogue score (whereby '0' was equivalent to 'no pain' and '10' equivalent to the worst 'conceivable pain.')</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Post-operative Pain</condition>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the intervention group, in addition to the above, the patient was placed in the Trendelenburg position (30°) and a pulmonary recruitment maneuver utilized, consisting of two manual inflations to a maximum pressure of 60 cm H2O. This was performed by the Anaesthetist, who held each positive pressure inflation for five seconds, with the valves on the operative ports fully open.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control group residual carbon dioxide pneumo-peritoneum was evacuated at the end of the procedure by passively allowing the abdomen to decompress by opening the operative ports.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intervention</intervention_name>
    <description>The patient was placed in the Trendelenburg position (30°) and two manual lung inflations to a maximum pressure of 60 cm H2O for five seconds, with the valves on the operative ports fully open.</description>
    <arm_group_label>intervention</arm_group_label>
    <other_name>pulmonary recruitment maneouvre</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients were recruited from a single Consultant's surgical clinic at the same&#xD;
             District General Hospital between August 2010 and February 2012. This study was&#xD;
             approved by the local ethics committee (National Research Ethics Service REC ref:&#xD;
             09/H0405/65) and informed consent was obtained from all patients after they had the&#xD;
             opportunity to study information leaflets that were also given to them. The trial was&#xD;
             designed as a prospectively randomized and double blind trial with a 1:1&#xD;
             (control:intervention) allocation.&#xD;
&#xD;
        The inclusion criteria was all adults with an American Society of Anesthesiologists (ASA)&#xD;
        physical status grade 1 or 2, who were undergoing elective laparoscopic cholecystectomy for&#xD;
        gallbladder disease or laparoscopic inguinal hernia repair performed as a transabdominal&#xD;
        preperitoneal procedure (TAP). All procedures and data collection occurred at a District&#xD;
        General Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The pre-operative exclusion criteria included patients younger than 18 years, those who&#xD;
        refused to give consent, those that had an inability to understand the research&#xD;
        questionnaire and pregnancy. Patients who were found to require additional procedures, for&#xD;
        example a conversion to open surgery, were excluded from the study prior to randomization.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Achal Khanna, MRCSEd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northampton General Hospital Northampton England</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northampton General Hopsital</name>
      <address>
        <city>Northampton</city>
        <state>Northamptonshire</state>
        <zip>NN15BD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>October 31, 2012</last_update_submitted>
  <last_update_submitted_qc>October 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northampton General Hospital NHS Trust</investigator_affiliation>
    <investigator_full_name>Achal Khanna</investigator_full_name>
    <investigator_title>Mr Achal Khanna Specialist Registrar - Surgery</investigator_title>
  </responsible_party>
  <keyword>laparoscopic pain prospective blinded trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_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/NCT01720433
org study id: lap pain trial NGH
nct id: NCT01720433
lead sponsor: 
has dmc: No
Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as
      causes of post-operative morbidity. This prospective, double-blind, randomized controlled
      trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by
      implementing a simple intra-operative technique.

      Patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or
      laparoscopic inguinal hernia repair will be recruited to the trial. Patients will be
      randomized to either the current standard (control group) or to receive an intervention to
      remove residual CO2. In the intervention group the pneumo-peritoneum will be removed, at the
      end of the operation, by placing the patient in the Trendelenburg position and utilising a
      pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of
      60 cm H2O. In the control group residual pneumo-peritoneum will be evacuated at the end of
      the procedure by passive decompression via the open operative ports.
This trial recruited 76 randomly assigned patients, 37 in the intervention group and 39 in
      the control group. The overall post-surgery pain scores, as analysed by two-way ANOVA, were
      significantly lower in the intervention group (P=0.0019). On Bonferroni post-tests both 12
      hour (P<0.01) and 24-hour (P<0.01) pain scores were significantly lower in the intervention
      group.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: pain scores at varying time points pot operatively
time frame: 48 hours
description: Pain scores were assessed by the use of a validated visual analogue score (whereby '0' was equivalent to 'no pain' and '10' equivalent to the worst 'conceivable pain.')
arm group label: intervention
arm group type: Experimental
description: In the intervention group, in addition to the above, the patient was placed in the Trendelenburg position (30°) and a pulmonary recruitment maneuver utilized, consisting of two manual inflations to a maximum pressure of 60 cm H2O. This was performed by the Anaesthetist, who held each positive pressure inflation for five seconds, with the valves on the operative ports fully open.
arm group label: control arm
arm group type: No Intervention
description: In the control group residual carbon dioxide pneumo-peritoneum was evacuated at the end of the procedure by passively allowing the abdomen to decompress by opening the operative ports.
intervention type: Procedure
intervention name: intervention
description: The patient was placed in the Trendelenburg position (30°) and two manual lung inflations to a maximum pressure of 60 cm H2O for five seconds, with the valves on the operative ports fully open.
arm group label: intervention
other name: pulmonary recruitment maneouvre
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Achal Khanna, MRCSEd
role: Principal Investigator
affiliation: Northampton General Hospital Northampton England
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Northampton General Hospital NHS Trust
investigator full name: Achal Khanna
investigator title: Mr Achal Khanna Specialist Registrar - Surgery
mesh term: Pain, Postoperative