<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/NCT04475809</url>
  </required_header>
  <id_info>
    <org_study_id>6251-1207-2020</org_study_id>
    <nct_id>NCT04475809</nct_id>
  </id_info>
  <brief_title>Different Maneuvers for Reducing Post-laparoscopic Pain</brief_title>
  <official_title>Different Maneuvers for Reducing Post-laparoscopic Shoulder and Abdominal Pain: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Laparoscopic surgeries are becoming more attractive because of early recovery. However,&#xD;
           post-laparoscopic shoulder and upper abdominal pain may cause more discomfort to the&#xD;
           patient than the pain at the incision site&#xD;
&#xD;
        -  Many strategies have been attempted, such as the use of nonsteroidal anti-inflammatory&#xD;
           drugs; however, the effect is limited, and there are no reliable methods available yet.&#xD;
&#xD;
        -  Recently, some techniques are introduced that can potentially alleviate various types of&#xD;
           pain through different mechanisms in patients after laparoscopic surgery such as&#xD;
           low-pressure pneumoperitoneum, intraperitoneal normal saline infusion, and pulmonary&#xD;
           recruitment maneuvers.&#xD;
&#xD;
        -  the investigators conduct this randomized controlled trial to evaluate the effectiveness&#xD;
           of different strategies on reducing the intensity of post-laparoscopic shoulder and&#xD;
           abdominal pain in patients undergoing laparoscopic gynecologic surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic surgery is becoming more popular due to smaller incision, faster recovery, less&#xD;
      postoperative pain, and earlier returns to normal activity . However post-laparoscopic&#xD;
      shoulder and upper abdominal pain may upset the patient more than the pain at the incision&#xD;
      site. The incidence of shoulder pain after laparoscopic gynecological surgery varies from 35%&#xD;
      to 80% and could be so severe at 24 hours after laparoscopic hysterectomy as well.&#xD;
&#xD;
      The mechanism of post laparoscopic shoulder and abdominal pain attributes to the insufflated&#xD;
      co2 in the abdominal cavity and become entrapped between the liver and the right diaphragm&#xD;
      causing irritation of the phrenic nerve, diaphragm and referred pain in the C4 dermatome. On&#xD;
      the other hand, the prolonged exposure to residual CO2 dissolution leads to intra-abdominal&#xD;
      acidosis and consequent peritoneal irritation and abdominal pain.&#xD;
&#xD;
      As long as the retention of CO2 is the key factor in the laparoscopy-induced shoulder and&#xD;
      abdominal pain, many strategies have been evolved to alleviate different types of pain in&#xD;
      patients undergoing laparoscopic surgeries such as usage of low-pressure pneumoperitoneum&#xD;
      (8-10 mmHg) that result in reducing the intensity of postoperative pain in comparison to&#xD;
      standard high-pressure pneumoperitoneum (12-15 mmHg). Although this low pressure may impair&#xD;
      visualization and jeopardize the surgeon's comfort during surgery, this method is proven to&#xD;
      be safe and feasible.&#xD;
&#xD;
      One of the maneuvers that have been proposed is an intraperitoneal normal saline infusion&#xD;
      (IPS) that increases intraperitoneal pressure to enhance the removal of residual CO2, as well&#xD;
      as offers a physiologic buffer system to wash out excess CO2.&#xD;
&#xD;
      Pulmonary recruitment maneuvers (PRM) has also a potential beneficial effect on alleviating&#xD;
      post-laparoscopic pain by mechanically increasing intraperitoneal pressure to accelerate the&#xD;
      elimination of residual CO2.&#xD;
&#xD;
      Because these variable techniques are mediated through different mechanisms, the&#xD;
      investigators hypothesize that combination of two different maneuvers may be ideal and more&#xD;
      effective in reducing post-laparoscopic shoulder and abdominal pain than any single or&#xD;
      standard maneuver in patients undergoing laparoscopic gynecologic surgeries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</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>
    <intervention_model_description>The patients will be divided randomly by a computer-generated randomization table into two equal groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Double (Participant, Outcomes Assessor) double-blinded ( patient and outcome assessors)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>changes in assessment of shoulder, abdominal and incisional pain</measure>
    <time_frame>at 1, 2, 4, 6, 12, 24, 48,72,96 hours postoperatively</time_frame>
    <description>will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of first request of analgesia</measure>
    <time_frame>within 24 hour postoperative</time_frame>
    <description>time elapsed from patient arrival to post anesthesia care unit to time of first patient call for analgesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total rescue analgesic requirement</measure>
    <time_frame>during the first postoperative 96 hours</time_frame>
    <description>if VAS ≥3 or on patient request, rescue analgesia will be given</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Gynecologic Disease</condition>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>high intra-abdominal pressure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group L</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>low intra-abdominal pressure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group LR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>low intra-abdominal pressure with pulmonary recruitment maneuver group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group LS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>low intra-abdominal pressure with intraperitoneal saline infusion group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>group C</intervention_name>
    <description>laparoscopy will be performed with 14-16 mmHg intra-abdominal pressure. At the end of the procedure routine method for CO2 removal, passive exsufflation, will be used by applying gentle abdominal pressure to evacuate the residual gas through the port site.</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group L</intervention_name>
    <description>laparoscopy will be performed with 8-10 mmHg intra-abdominal pressure and routine passive exsufflation will be applied for CO2 removal at the end of the procedure.</description>
    <arm_group_label>Group L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group LR</intervention_name>
    <description>the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure pulmonary recruitment maneuver (PRM) will be done; which consists of five manual pulmonary inflations at a maximum pressure of 40 cm H2O and the fifth will be held for 5 seconds. During this procedure, the surgeon is instructed to keep the port sleeve valve fully opened to allow the CO2 to escape the abdominal cavity.</description>
    <arm_group_label>Group LR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group LS</intervention_name>
    <description>the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure, intraperitoneal normal saline (IPS) will be infused for removal of the intra-abdominal CO2; in which we fill the upper part of the abdominal cavity evenly and bilaterally with isotonic normal saline (15-20 mL/kg body weight)</description>
    <arm_group_label>Group LS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient acceptance.&#xD;
&#xD;
          -  BMI ≤35 kg/m2.&#xD;
&#xD;
          -  ASA I and ASA II.&#xD;
&#xD;
          -  Scheduled for elective laparoscopic gynecologic surgeries for benign lesions under&#xD;
             general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pre-existing chronic pain disorders.&#xD;
&#xD;
          -  Patients on opioid or sedative use.&#xD;
&#xD;
          -  Psychological and mental disorders.&#xD;
&#xD;
          -  Severe hypertensive, cardiac, hepatic and renal patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of medicine, zagazig university</name>
      <address>
        <city>Zagazig</city>
        <state>Elsharqya</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Kaloo P, Armstrong S, Kaloo C, Jordan V. Interventions to reduce shoulder pain following gynaecological laparoscopic procedures. Cochrane Database Syst Rev. 2019 Jan 30;1(1):CD011101. doi: 10.1002/14651858.CD011101.pub2.</citation>
    <PMID>30699235</PMID>
  </reference>
  <reference>
    <citation>Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.</citation>
    <PMID>22184293</PMID>
  </reference>
  <reference>
    <citation>Yasir M, Mehta KS, Banday VH, Aiman A, Masood I, Iqbal B. Evaluation of post operative shoulder tip pain in low pressure versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy. Surgeon. 2012 Apr;10(2):71-4. doi: 10.1016/j.surge.2011.02.003. Epub 2011 Mar 21.</citation>
    <PMID>22385527</PMID>
  </reference>
  <reference>
    <citation>Pergialiotis V, Vlachos DE, Kontzoglou K, Perrea D, Vlachos GD. Pulmonary recruitment maneuver to reduce pain after laparoscopy: a meta-analysis of randomized controlled trials. Surg Endosc. 2015 Aug;29(8):2101-8. doi: 10.1007/s00464-014-3934-7. Epub 2014 Nov 1.</citation>
    <PMID>25361653</PMID>
  </reference>
  <reference>
    <citation>Davari-Tanha F, Samimi S, Khalaj Z, Bastanhagh E. Comparison of Intraperitoneal Normal Saline Infusion with Pulmonary Recruitment Maneuver in Reducing Shoulder and Upper Abdomen Pain Following Gynecologic Laparoscopic Procedures: A Randomized, Controlled, Triple-Blind Trial. Anesth Pain Med. 2019 Jun 2;9(3):e92444. doi: 10.5812/aapm.92444. eCollection 2019 Jun.</citation>
    <PMID>31497525</PMID>
  </reference>
  <reference>
    <citation>Sharami SH, Sharami MB, Abdollahzadeh M, Keyvan A. Randomised clinical trial of the influence of pulmonary recruitment manoeuvre on reducing shoulder pain after laparoscopy. J Obstet Gynaecol. 2010;30(5):505-10. doi: 10.3109/01443611003802313.</citation>
    <PMID>20604657</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 15, 2022</last_update_submitted>
  <last_update_submitted_qc>July 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Shereen Elsayed Abd Ellatif</investigator_full_name>
    <investigator_title>lecturer of anesthesia and surgical intensive care</investigator_title>
  </responsible_party>
  <keyword>Pulmonary recruitment maneuvers</keyword>
  <keyword>low-pressure pneumoperitoneum</keyword>
  <keyword>laparoscopic Shoulder and Abdominal Pain</keyword>
  <keyword>laparoscopic gynecologic surgery</keyword>
  <keyword>intraperitoneal saline infusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genital Diseases, Female</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>planned after the completion of the study and publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>planned after the completion of the study and publication</ipd_time_frame>
    <ipd_access_criteria>principal investigator</ipd_access_criteria>
  </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/NCT04475809
org study id: 6251-1207-2020
nct id: NCT04475809
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
-  Laparoscopic surgeries are becoming more attractive because of early recovery. However,
           post-laparoscopic shoulder and upper abdominal pain may cause more discomfort to the
           patient than the pain at the incision site

        -  Many strategies have been attempted, such as the use of nonsteroidal anti-inflammatory
           drugs; however, the effect is limited, and there are no reliable methods available yet.

        -  Recently, some techniques are introduced that can potentially alleviate various types of
           pain through different mechanisms in patients after laparoscopic surgery such as
           low-pressure pneumoperitoneum, intraperitoneal normal saline infusion, and pulmonary
           recruitment maneuvers.

        -  the investigators conduct this randomized controlled trial to evaluate the effectiveness
           of different strategies on reducing the intensity of post-laparoscopic shoulder and
           abdominal pain in patients undergoing laparoscopic gynecologic surgeries.
Laparoscopic surgery is becoming more popular due to smaller incision, faster recovery, less
      postoperative pain, and earlier returns to normal activity . However post-laparoscopic
      shoulder and upper abdominal pain may upset the patient more than the pain at the incision
      site. The incidence of shoulder pain after laparoscopic gynecological surgery varies from 35%
      to 80% and could be so severe at 24 hours after laparoscopic hysterectomy as well.

      The mechanism of post laparoscopic shoulder and abdominal pain attributes to the insufflated
      co2 in the abdominal cavity and become entrapped between the liver and the right diaphragm
      causing irritation of the phrenic nerve, diaphragm and referred pain in the C4 dermatome. On
      the other hand, the prolonged exposure to residual CO2 dissolution leads to intra-abdominal
      acidosis and consequent peritoneal irritation and abdominal pain.

      As long as the retention of CO2 is the key factor in the laparoscopy-induced shoulder and
      abdominal pain, many strategies have been evolved to alleviate different types of pain in
      patients undergoing laparoscopic surgeries such as usage of low-pressure pneumoperitoneum
      (8-10 mmHg) that result in reducing the intensity of postoperative pain in comparison to
      standard high-pressure pneumoperitoneum (12-15 mmHg). Although this low pressure may impair
      visualization and jeopardize the surgeon's comfort during surgery, this method is proven to
      be safe and feasible.

      One of the maneuvers that have been proposed is an intraperitoneal normal saline infusion
      (IPS) that increases intraperitoneal pressure to enhance the removal of residual CO2, as well
      as offers a physiologic buffer system to wash out excess CO2.

      Pulmonary recruitment maneuvers (PRM) has also a potential beneficial effect on alleviating
      post-laparoscopic pain by mechanically increasing intraperitoneal pressure to accelerate the
      elimination of residual CO2.

      Because these variable techniques are mediated through different mechanisms, the
      investigators hypothesize that combination of two different maneuvers may be ideal and more
      effective in reducing post-laparoscopic shoulder and abdominal pain than any single or
      standard maneuver in patients undergoing laparoscopic gynecologic surgeries.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The patients will be divided randomly by a computer-generated randomization table into two equal groups
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Double (Participant, Outcomes Assessor) double-blinded ( patient and outcome assessors)
measure: changes in assessment of shoulder, abdominal and incisional pain
time frame: at 1, 2, 4, 6, 12, 24, 48,72,96 hours postoperatively
description: will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
measure: Time of first request of analgesia
time frame: within 24 hour postoperative
description: time elapsed from patient arrival to post anesthesia care unit to time of first patient call for analgesia
measure: Total rescue analgesic requirement
time frame: during the first postoperative 96 hours
description: if VAS ≥3 or on patient request, rescue analgesia will be given
arm group label: Group C
arm group type: Placebo Comparator
description: high intra-abdominal pressure
arm group label: Group L
arm group type: Active Comparator
description: low intra-abdominal pressure
arm group label: Group LR
arm group type: Active Comparator
description: low intra-abdominal pressure with pulmonary recruitment maneuver group
arm group label: Group LS
arm group type: Active Comparator
description: low intra-abdominal pressure with intraperitoneal saline infusion group
intervention type: Procedure
intervention name: group C
description: laparoscopy will be performed with 14-16 mmHg intra-abdominal pressure. At the end of the procedure routine method for CO2 removal, passive exsufflation, will be used by applying gentle abdominal pressure to evacuate the residual gas through the port site.
arm group label: Group C
intervention type: Procedure
intervention name: Group L
description: laparoscopy will be performed with 8-10 mmHg intra-abdominal pressure and routine passive exsufflation will be applied for CO2 removal at the end of the procedure.
arm group label: Group L
intervention type: Procedure
intervention name: Group LR
description: the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure pulmonary recruitment maneuver (PRM) will be done; which consists of five manual pulmonary inflations at a maximum pressure of 40 cm H2O and the fifth will be held for 5 seconds. During this procedure, the surgeon is instructed to keep the port sleeve valve fully opened to allow the CO2 to escape the abdominal cavity.
arm group label: Group LR
intervention type: Procedure
intervention name: Group LS
description: the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure, intraperitoneal normal saline (IPS) will be infused for removal of the intra-abdominal CO2; in which we fill the upper part of the abdominal cavity evenly and bilaterally with isotonic normal saline (15-20 mL/kg body weight)
arm group label: Group LS
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Kaloo P, Armstrong S, Kaloo C, Jordan V. Interventions to reduce shoulder pain following gynaecological laparoscopic procedures. Cochrane Database Syst Rev. 2019 Jan 30;1(1):CD011101. doi: 10.1002/14651858.CD011101.pub2.
PMID: 30699235
citation: Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
PMID: 22184293
citation: Yasir M, Mehta KS, Banday VH, Aiman A, Masood I, Iqbal B. Evaluation of post operative shoulder tip pain in low pressure versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy. Surgeon. 2012 Apr;10(2):71-4. doi: 10.1016/j.surge.2011.02.003. Epub 2011 Mar 21.
PMID: 22385527
citation: Pergialiotis V, Vlachos DE, Kontzoglou K, Perrea D, Vlachos GD. Pulmonary recruitment maneuver to reduce pain after laparoscopy: a meta-analysis of randomized controlled trials. Surg Endosc. 2015 Aug;29(8):2101-8. doi: 10.1007/s00464-014-3934-7. Epub 2014 Nov 1.
PMID: 25361653
citation: Davari-Tanha F, Samimi S, Khalaj Z, Bastanhagh E. Comparison of Intraperitoneal Normal Saline Infusion with Pulmonary Recruitment Maneuver in Reducing Shoulder and Upper Abdomen Pain Following Gynecologic Laparoscopic Procedures: A Randomized, Controlled, Triple-Blind Trial. Anesth Pain Med. 2019 Jun 2;9(3):e92444. doi: 10.5812/aapm.92444. eCollection 2019 Jun.
PMID: 31497525
citation: Sharami SH, Sharami MB, Abdollahzadeh M, Keyvan A. Randomised clinical trial of the influence of pulmonary recruitment manoeuvre on reducing shoulder pain after laparoscopy. J Obstet Gynaecol. 2010;30(5):505-10. doi: 10.3109/01443611003802313.
PMID: 20604657
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Shereen Elsayed Abd Ellatif
investigator title: lecturer of anesthesia and surgical intensive care
mesh term: Genital Diseases, Female
sharing ipd: Yes
ipd description: planned after the completion of the study and publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: planned after the completion of the study and publication
ipd access criteria: principal investigator