<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/NCT03241602</url>
  </required_header>
  <id_info>
    <org_study_id>N-61-2017</org_study_id>
    <nct_id>NCT03241602</nct_id>
  </id_info>
  <brief_title>Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain</brief_title>
  <official_title>Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain in Patient Undergoing Diagnostic Gynacological Laproscopy. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The advancement of laparoscopy and minimal access surgery has greatly influenced the&#xD;
      evolution of anaesthetic techniques. However, postoperative pain intensity may be&#xD;
      significant, with up to 40% of patients unsatisfied by routine analgesia and up to 80%may&#xD;
      require rescue opioids during their hospital stay. Diagnostic gynaecological laparoscopy has&#xD;
      no origin of pain other than the abdominal gas insufflations itself only. Pain relief after&#xD;
      diagnostic laparoscopy, being a day case, is an issue of great practical importance.The aim&#xD;
      of this study is to compare the efficacy of combining both pulmonary recruitment and&#xD;
      intraperitoneal lidocaine versus pulmonary recruitment alone to control post - laparoscopy&#xD;
      shoulder pain regarding severity and frequency&#xD;
&#xD;
      Study Design :&#xD;
&#xD;
      Interventional Prospective Randomized Double-blind Controlled Trial&#xD;
&#xD;
      Methodology This study is a randomized double blinded control trial. It will be conducted at&#xD;
      Kasr-al ainy hospital, faculty of medicine, Cairo university. Approval of ethical committee&#xD;
      and written informed consent will be obtained. 88 female patients, aged 18-45 years , ASA 1&#xD;
      or 2 , scheduled for diagnostic gynaecologic laparoscopy will be included. Females who are&#xD;
      (ASA) ≥ 3, alcoholic, drug abusers, allergic to amide LAs, with pre-existing chronic pain&#xD;
      disorders, or receiving opioids or tranquilizers for &gt; 1 week preoperatively are excluded.&#xD;
      Also if the operation included any interventional procedure or was converted to an open&#xD;
      procedure, or had postoperative complications that could increase postoperative pain, it will&#xD;
      be excluded. Consenting patients will be randomly allocated to either of three study groups :&#xD;
      GPL : Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine.&#xD;
      GPS: Patients will receive pulmonary recruitment maneuver and intraperitoneal saline. GC :&#xD;
      Patients will receive passive exsufflation through the port site. The patient will attend at&#xD;
      the pre anaesthetic room 1 hour before the procedure. A 20 Gauge cannula will be inserted&#xD;
      peripherally and the patient will be premedicated with intravenous Midazolam 0.02 mg kg-1,&#xD;
      Ranitidine 50 mg, 10 mg Metoclopramide.&#xD;
&#xD;
      In the operative room, standard monitoring will be applied to the patient. Anaesthesia will&#xD;
      be induced with propofol 2 mg kg-1, Fentanyl 1 mcg kg-1 , Atracurium 0.5 mg kg-1 and the&#xD;
      trachea will be intubated after mask ventilation for 3 minutes. Anaesthesia will be&#xD;
      maintained with IPPV , isoflurane in 100% oxygen and muscular relaxation with atracurium&#xD;
      0.1mg kg-1every 15 minutes. Depth of anaesthesia was adjusted according to clinical signs.&#xD;
      Laparoscopy is done using CO2 as distension medium. The patient will be placed in a&#xD;
      Trendelenburg position in order to provide optimum conditions for laparoscopic view. In&#xD;
      groups GPL and GPS , the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5&#xD;
      mg/kg) or the same volume of normal saline, for intraperitoneal administration. This ensures&#xD;
      the surgeon and the anaesthesiologist are blind to the patient's group. The solution to be&#xD;
      instilled will be splashed under the right diaphragmatic area by the surgeon and complete the&#xD;
      procedure. At the end of the procedure, the patient will be placed back from trendelenburg&#xD;
      position. In groups GPL and GPS , a pulmonary recruitment maneuver will be done and consist&#xD;
      of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The&#xD;
      anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds. In&#xD;
      group GC CO2 will be removed by passive exsufflation through the port site and gentle&#xD;
      abdominal pressure will be applied to evacuate the residual gas. Residual neuromuscular block&#xD;
      is antagonized with atropine 1.2 mg and neostigmine 2.5 mg and extubation will be done&#xD;
      according to extubation criteria. In the recovery room, patient will be asked about&#xD;
      post-operative pain and it'll be controlled using Meperidine 1 mg kg-1 and given by a nurse&#xD;
      who is unaware of the nature of the intraoperative analgesia. Then, the patient is discharged&#xD;
      to the ward according to the standard criteria. In the ward, patient will be asked to fulfill&#xD;
      a questionnaire at 6, 8 and 10 hours postoperative using the visual analogue score (VAS) of&#xD;
      pain severity. Patients were questioned as to presence of Side effects (nausea, vomiting).&#xD;
&#xD;
      Possible Risk : Pneumothorax , Local anaesthetic toxicity : CNS depression (lightheadedness&#xD;
      and dizziness, difficulty focusing, tinnitus, confusion, and circumoral numbness) ,&#xD;
      excitation ( tremors tonic-clonic convulsions) , respiratory depression and cardiac&#xD;
      dysrhythmias .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The advancement of laparoscopy and minimal access surgery has greatly influenced the&#xD;
      evolution of anaesthetic techniques. However, postoperative pain intensity may be&#xD;
      significant, with up to 40% of patients unsatisfied by routine analgesia and up to 80%may&#xD;
      require rescue opioids during their hospital stay. Diagnostic gynaecological laparoscopy has&#xD;
      no origin of pain other than the abdominal gas insufflations itself only. Pain relief after&#xD;
      diagnostic laparoscopy, being a day case, is an issue of great practical importance. Pain&#xD;
      after Laparoscopy is considered to arise from 3 main sources: the incision sites (50% to&#xD;
      70%), the pneumoperitoneum (20% to 30%) in association with both local (peritoneal and&#xD;
      diaphragmatic stretching, ischemia, acidosis) and systemic (hypercarbia causing sympathetic&#xD;
      nervous system excitation resulting in amplification of the local tissue inflammatory&#xD;
      response) changes, and the procedure site (10% to 20%) as postcholecystectomy wound within&#xD;
      the liver. Pain can also be referred from the subdiaphragmatic region as shoulder pain.&#xD;
      Shoulder pain is often mild in intensity and can remain for 24 hours. Incisional pain is&#xD;
      usually mild to moderate in intensity, and maximal immediately postoperatively, subsiding&#xD;
      with time. Local anaesthetic (LA) to be filtered preincisional can not entirely eliminate&#xD;
      postoperative pain, especially shoulder pain, In contrast, Intraperitoneal local anaesthetic&#xD;
      instillation is a known method of providing post-laparoscopy pain relief. Lidocaine is safe&#xD;
      and effective in pain relief, improving respiratory functions and early return of bowel&#xD;
      motility. The local anaesthetic blocks visceral nociception from the peritoneum locally as&#xD;
      well as a having a systemic effect after absorption through the peritoneal surface . The&#xD;
      systemic analgesic effect of LA is induced through an anti-inflammatory effect by peripheral&#xD;
      suppression of acute chemically induced pain, inhibition of nerve conduction, as well as&#xD;
      having a central antihyperalgesic effect. The pulmonary recruitment manoeuvre (RM) can&#xD;
      mechanically remove residual carbon dioxide (CO2) after laparoscopic surgery, reduce phrenic&#xD;
      nerve irritation, and consequently reduce post-laparoscopic shoulder and upper abdominal&#xD;
      pain. The combined effect of these two methods ,using various local anaesthetics , on pain&#xD;
      following laparoscopic procedures has not been reported. This study will investigate the&#xD;
      efficacy of combining local anaesthetic infiltration of Lidocaine with pulmonary recruitment&#xD;
      manoeuvre on postoperative pain following diagnostic Gynaecologic laparoscopy. For blinding,&#xD;
      Pulmonary recruitment maneuver will be combined with intraperitoneal instillation of saline.&#xD;
      However, intraperitoneal saline is a known simple maneuver to decrease shoulder pain. A&#xD;
      possible explanation is that saline displaces residual pockets of gas from within the&#xD;
      peritoneal cavity and thereby prevents loss of suction support between the liver and&#xD;
      diaphragm. In this study we hypothesized that combining simple maneuver like pulmonary&#xD;
      recruitment with intraperitoneal instillation of local anaesthetic would be more effective&#xD;
      than pulmonary recruitment alone.&#xD;
&#xD;
      The aim of this study is to compare the efficacy of combining both pulmonary recruitment and&#xD;
      intraperitoneal lidocaine versus pulmonary recruitment alone to control post - laparoscopy&#xD;
      shoulder pain regarding severity and frequency&#xD;
&#xD;
      Study Design :&#xD;
&#xD;
      Interventional Prospective Randomized Double-blind Controlled Trial&#xD;
&#xD;
      Study Methods&#xD;
&#xD;
      Methodology This study is a randomized double blinded control trial. It will be conducted at&#xD;
      Kasr-al ainy hospital, faculty of medicine, Cairo university. Approval of ethical committee&#xD;
      and written informed consent will be obtained. 88 female patients, aged 18-45 years , ASA I&#xD;
      or II , scheduled for diagnostic gynaecologic laparoscopy will be included. Females who are&#xD;
      (ASA) ≥ 3, alcoholic, drug abusers, allergic to amide LAs, with pre-existing chronic pain&#xD;
      disorders, or receiving opioids or tranquilizers for &gt; 1 week preoperatively are excluded.&#xD;
      Also if the operation included any interventional procedure or was converted to an open&#xD;
      procedure, or had postoperative complications that could increase postoperative pain, it will&#xD;
      be excluded. Consenting patients will be randomly allocated to either of three study groups :&#xD;
      GPL : Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine.&#xD;
      GPS: Patients will receive pulmonary recruitment maneuver and intraperitoneal saline. GC :&#xD;
      Patients will receive passive exsufflation through the port site. The patient will attend at&#xD;
      the pre anaesthetic room 1 hour before the procedure. A 20 Gauge cannula will be inserted&#xD;
      peripherally and the patient will be premedicated with intravenous Midazolam 0.02 mg kg-1,&#xD;
      Ranitidine 50 mg, 10 mg Metoclopramide.&#xD;
&#xD;
      In the operative room, standard monitoring (electrocardiography, pulse oximetry and&#xD;
      non-invasive blood pressure measurement) will be applied to the patient.&#xD;
&#xD;
      Anaesthesia will be induced with propofol 2 mg/ kg, Fentanyl 1 mcg/ kg , Atracurium 0.5 mg&#xD;
      kg-1 and the trachea will be intubated after mask ventilation for 3 minutes. Anaesthesia will&#xD;
      be maintained with IPPV , isoflurane in 100% oxygen and muscular relaxation with atracurium&#xD;
      0.1mg kg-1every 15 minutes. Depth of anaesthesia was adjusted according to clinical signs.&#xD;
      Laparoscopy is done using CO2 as distension medium. Veress needle is introduced at first&#xD;
      through lower border of umbilicus and water test is done to ensure intraperitoneal placement.&#xD;
      Then, reaching proper distension pressure is ensured by disappearance of dullness over lower&#xD;
      border of the liver. The pressure will be about 15 mmHg. The patient will be placed in a&#xD;
      Trendelenburg position in order to provide optimum conditions for laparoscopic view. A 10 mm&#xD;
      laparoscopic trocar is introduced with 45 degree towards pelvis and zero camera is introduced&#xD;
      through the cannula trocar. Second puncture can be done through right or left iliac fossae.&#xD;
      In groups GPL and GPS , the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5&#xD;
      mg/kg) or the same volume of normal saline, for intraperitoneal administration. This ensures&#xD;
      the surgeon and the anaesthesiologist are blind to the patient's group. The solution to be&#xD;
      instilled will be splashed under the right diaphragmatic area by the surgeon and complete the&#xD;
      procedure. At the end of the procedure, the patient will be placed back from trendelenburg&#xD;
      position. In groups GPL and GPS , a pulmonary recruitment maneuver will be done and consist&#xD;
      of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The&#xD;
      anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds. In&#xD;
      group GC CO2 will be removed by passive exsufflation through the port site and gentle&#xD;
      abdominal pressure will be applied to evacuate the residual gas. Residual neuromuscular block&#xD;
      is antagonized with atropine 1.2 mg and neostigmine 2.5 mg and extubation will be done&#xD;
      according to extubation criteria. In the recovery room, patient will be asked about&#xD;
      post-operative pain and it'll be controlled using Meperidine 1 mg/ kg and given by a nurse&#xD;
      who is unaware of the nature of the intraoperative analgesia. Then, the patient is discharged&#xD;
      to the ward according to the standard criteria. In the ward, patient will be asked to fulfill&#xD;
      a questionnaire at 6, 8 and 10 hours postoperative using the visual analogue score (VAS) of&#xD;
      pain severity. The patients were asked to complete a 10-cm linear analogue scale for shoulder&#xD;
      pain, which ranged from 0 for no pain at all to 10 for the worst pain imaginable. Patients&#xD;
      were questioned as to presence of Side effects (nausea, vomiting).&#xD;
&#xD;
      Possible Risk Pneumothorax , Local anaesthetic toxicity : CNS depression (lightheadedness and&#xD;
      dizziness, difficulty focusing, tinnitus, confusion, and circumoral numbness) , excitation (&#xD;
      tremors tonic-clonic convulsions) , respiratory depression and cardiac dysrhythmias .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 28, 2017</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain measuring 6 hours postoperative</measure>
    <time_frame>6 hours post-oprative</time_frame>
    <description>post-operative pain measured using Visual Analogue Scale ,The patients were asked to complete a 10-cm linear analogue scale for shoulder pain, which ranged from 0 for no pain at all to 10 for the worst pain imaginable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain measuring Visual analogue scale 8 and 10 hour</measure>
    <time_frame>8 , 10 Hours Post-operative</time_frame>
    <description>questionnaire will done for the patient at 8, 10 hour using VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Nausea and Vomitting</measure>
    <time_frame>2 hours</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Decrease Post Laproscopy Shoulder and Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>group of Pulmonary recruitment &amp; Intraperitoneal libocai</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group of Intraperitoneal lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group of pulmonary recruitment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group receive passive exsufflation through port</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intraperitoneal lidocaine</intervention_name>
    <description>the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5 mg/kg) or the same volume of normal saline, for intraperitoneal administration. The solution to be instillated will be splashed under the right diaphragmatic area by the surgeon and complete the procedure.</description>
    <arm_group_label>Group of Intraperitoneal lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary Recruitment</intervention_name>
    <description>pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The anestheiologist hold the fifth positive pressure inflation for approximately 5 seconds</description>
    <arm_group_label>Group of pulmonary recruitment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Combined intraperitoneal lidocaine and pulmonary recruitment maneuver</intervention_name>
    <description>the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5 mg/kg) or the same volume of normal saline, for intraperitoneal administration. The solution to be instillated will be splashed under the right diaphragmatic area by the surgeon and complete the procedure before the recovery of the patient pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The anestheiologist hold the fifth positive pressure inflation for approximately 5 seconds</description>
    <arm_group_label>group of Pulmonary recruitment &amp; Intraperitoneal libocai</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female patients, aged 18-45 years scheduled for diagnostic Gynaecologic laparoscopy.&#xD;
&#xD;
          2. American Society of Anesthesiology physical status 1 or 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. American Society of Anesthesiology (ASA) physical status ≥ 3&#xD;
&#xD;
          2. Allergy or hypersensitivity to amide type local anaesthetics;&#xD;
&#xD;
          3. Pre-existing chronic pain disorders;&#xD;
&#xD;
          4. Receiving opioids or tranquilizers for &gt; 1 week preoperatively;&#xD;
&#xD;
          5. History of alcohol or drug abuse.&#xD;
&#xD;
          6. If the operation included any interventional procedure or was converted to an open&#xD;
             procedure, or had postoperative complications that could increase postoperative pain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>as the selected surgery is diagnostic laparoscopy done only for female as this type of surgery there will be no source of pain other than abdominal distension</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of medicine CAIRO UNIVERISTY</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sherin Refaat</investigator_full_name>
    <investigator_title>lecturer of Anesthiology at faculty of medicine Cairo univeristy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Pain</mesh_term>
  </condition_browse>
  <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/NCT03241602
org study id: N-61-2017
nct id: NCT03241602
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The advancement of laparoscopy and minimal access surgery has greatly influenced the
      evolution of anaesthetic techniques. However, postoperative pain intensity may be
      significant, with up to 40% of patients unsatisfied by routine analgesia and up to 80%may
      require rescue opioids during their hospital stay. Diagnostic gynaecological laparoscopy has
      no origin of pain other than the abdominal gas insufflations itself only. Pain relief after
      diagnostic laparoscopy, being a day case, is an issue of great practical importance.The aim
      of this study is to compare the efficacy of combining both pulmonary recruitment and
      intraperitoneal lidocaine versus pulmonary recruitment alone to control post - laparoscopy
      shoulder pain regarding severity and frequency

      Study Design :

      Interventional Prospective Randomized Double-blind Controlled Trial

      Methodology This study is a randomized double blinded control trial. It will be conducted at
      Kasr-al ainy hospital, faculty of medicine, Cairo university. Approval of ethical committee
      and written informed consent will be obtained. 88 female patients, aged 18-45 years , ASA 1
      or 2 , scheduled for diagnostic gynaecologic laparoscopy will be included. Females who are
      (ASA) ≥ 3, alcoholic, drug abusers, allergic to amide LAs, with pre-existing chronic pain
      disorders, or receiving opioids or tranquilizers for > 1 week preoperatively are excluded.
      Also if the operation included any interventional procedure or was converted to an open
      procedure, or had postoperative complications that could increase postoperative pain, it will
      be excluded. Consenting patients will be randomly allocated to either of three study groups :
      GPL : Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine.
      GPS: Patients will receive pulmonary recruitment maneuver and intraperitoneal saline. GC :
      Patients will receive passive exsufflation through the port site. The patient will attend at
      the pre anaesthetic room 1 hour before the procedure. A 20 Gauge cannula will be inserted
      peripherally and the patient will be premedicated with intravenous Midazolam 0.02 mg kg-1,
      Ranitidine 50 mg, 10 mg Metoclopramide.

      In the operative room, standard monitoring will be applied to the patient. Anaesthesia will
      be induced with propofol 2 mg kg-1, Fentanyl 1 mcg kg-1 , Atracurium 0.5 mg kg-1 and the
      trachea will be intubated after mask ventilation for 3 minutes. Anaesthesia will be
      maintained with IPPV , isoflurane in 100% oxygen and muscular relaxation with atracurium
      0.1mg kg-1every 15 minutes. Depth of anaesthesia was adjusted according to clinical signs.
      Laparoscopy is done using CO2 as distension medium. The patient will be placed in a
      Trendelenburg position in order to provide optimum conditions for laparoscopic view. In
      groups GPL and GPS , the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5
      mg/kg) or the same volume of normal saline, for intraperitoneal administration. This ensures
      the surgeon and the anaesthesiologist are blind to the patient's group. The solution to be
      instilled will be splashed under the right diaphragmatic area by the surgeon and complete the
      procedure. At the end of the procedure, the patient will be placed back from trendelenburg
      position. In groups GPL and GPS , a pulmonary recruitment maneuver will be done and consist
      of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The
      anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds. In
      group GC CO2 will be removed by passive exsufflation through the port site and gentle
      abdominal pressure will be applied to evacuate the residual gas. Residual neuromuscular block
      is antagonized with atropine 1.2 mg and neostigmine 2.5 mg and extubation will be done
      according to extubation criteria. In the recovery room, patient will be asked about
      post-operative pain and it'll be controlled using Meperidine 1 mg kg-1 and given by a nurse
      who is unaware of the nature of the intraoperative analgesia. Then, the patient is discharged
      to the ward according to the standard criteria. In the ward, patient will be asked to fulfill
      a questionnaire at 6, 8 and 10 hours postoperative using the visual analogue score (VAS) of
      pain severity. Patients were questioned as to presence of Side effects (nausea, vomiting).

      Possible Risk : Pneumothorax , Local anaesthetic toxicity : CNS depression (lightheadedness
      and dizziness, difficulty focusing, tinnitus, confusion, and circumoral numbness) ,
      excitation ( tremors tonic-clonic convulsions) , respiratory depression and cardiac
      dysrhythmias .
The advancement of laparoscopy and minimal access surgery has greatly influenced the
      evolution of anaesthetic techniques. However, postoperative pain intensity may be
      significant, with up to 40% of patients unsatisfied by routine analgesia and up to 80%may
      require rescue opioids during their hospital stay. Diagnostic gynaecological laparoscopy has
      no origin of pain other than the abdominal gas insufflations itself only. Pain relief after
      diagnostic laparoscopy, being a day case, is an issue of great practical importance. Pain
      after Laparoscopy is considered to arise from 3 main sources: the incision sites (50% to
      70%), the pneumoperitoneum (20% to 30%) in association with both local (peritoneal and
      diaphragmatic stretching, ischemia, acidosis) and systemic (hypercarbia causing sympathetic
      nervous system excitation resulting in amplification of the local tissue inflammatory
      response) changes, and the procedure site (10% to 20%) as postcholecystectomy wound within
      the liver. Pain can also be referred from the subdiaphragmatic region as shoulder pain.
      Shoulder pain is often mild in intensity and can remain for 24 hours. Incisional pain is
      usually mild to moderate in intensity, and maximal immediately postoperatively, subsiding
      with time. Local anaesthetic (LA) to be filtered preincisional can not entirely eliminate
      postoperative pain, especially shoulder pain, In contrast, Intraperitoneal local anaesthetic
      instillation is a known method of providing post-laparoscopy pain relief. Lidocaine is safe
      and effective in pain relief, improving respiratory functions and early return of bowel
      motility. The local anaesthetic blocks visceral nociception from the peritoneum locally as
      well as a having a systemic effect after absorption through the peritoneal surface . The
      systemic analgesic effect of LA is induced through an anti-inflammatory effect by peripheral
      suppression of acute chemically induced pain, inhibition of nerve conduction, as well as
      having a central antihyperalgesic effect. The pulmonary recruitment manoeuvre (RM) can
      mechanically remove residual carbon dioxide (CO2) after laparoscopic surgery, reduce phrenic
      nerve irritation, and consequently reduce post-laparoscopic shoulder and upper abdominal
      pain. The combined effect of these two methods ,using various local anaesthetics , on pain
      following laparoscopic procedures has not been reported. This study will investigate the
      efficacy of combining local anaesthetic infiltration of Lidocaine with pulmonary recruitment
      manoeuvre on postoperative pain following diagnostic Gynaecologic laparoscopy. For blinding,
      Pulmonary recruitment maneuver will be combined with intraperitoneal instillation of saline.
      However, intraperitoneal saline is a known simple maneuver to decrease shoulder pain. A
      possible explanation is that saline displaces residual pockets of gas from within the
      peritoneal cavity and thereby prevents loss of suction support between the liver and
      diaphragm. In this study we hypothesized that combining simple maneuver like pulmonary
      recruitment with intraperitoneal instillation of local anaesthetic would be more effective
      than pulmonary recruitment alone.

      The aim of this study is to compare the efficacy of combining both pulmonary recruitment and
      intraperitoneal lidocaine versus pulmonary recruitment alone to control post - laparoscopy
      shoulder pain regarding severity and frequency

      Study Design :

      Interventional Prospective Randomized Double-blind Controlled Trial

      Study Methods

      Methodology This study is a randomized double blinded control trial. It will be conducted at
      Kasr-al ainy hospital, faculty of medicine, Cairo university. Approval of ethical committee
      and written informed consent will be obtained. 88 female patients, aged 18-45 years , ASA I
      or II , scheduled for diagnostic gynaecologic laparoscopy will be included. Females who are
      (ASA) ≥ 3, alcoholic, drug abusers, allergic to amide LAs, with pre-existing chronic pain
      disorders, or receiving opioids or tranquilizers for > 1 week preoperatively are excluded.
      Also if the operation included any interventional procedure or was converted to an open
      procedure, or had postoperative complications that could increase postoperative pain, it will
      be excluded. Consenting patients will be randomly allocated to either of three study groups :
      GPL : Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine.
      GPS: Patients will receive pulmonary recruitment maneuver and intraperitoneal saline. GC :
      Patients will receive passive exsufflation through the port site. The patient will attend at
      the pre anaesthetic room 1 hour before the procedure. A 20 Gauge cannula will be inserted
      peripherally and the patient will be premedicated with intravenous Midazolam 0.02 mg kg-1,
      Ranitidine 50 mg, 10 mg Metoclopramide.

      In the operative room, standard monitoring (electrocardiography, pulse oximetry and
      non-invasive blood pressure measurement) will be applied to the patient.

      Anaesthesia will be induced with propofol 2 mg/ kg, Fentanyl 1 mcg/ kg , Atracurium 0.5 mg
      kg-1 and the trachea will be intubated after mask ventilation for 3 minutes. Anaesthesia will
      be maintained with IPPV , isoflurane in 100% oxygen and muscular relaxation with atracurium
      0.1mg kg-1every 15 minutes. Depth of anaesthesia was adjusted according to clinical signs.
      Laparoscopy is done using CO2 as distension medium. Veress needle is introduced at first
      through lower border of umbilicus and water test is done to ensure intraperitoneal placement.
      Then, reaching proper distension pressure is ensured by disappearance of dullness over lower
      border of the liver. The pressure will be about 15 mmHg. The patient will be placed in a
      Trendelenburg position in order to provide optimum conditions for laparoscopic view. A 10 mm
      laparoscopic trocar is introduced with 45 degree towards pelvis and zero camera is introduced
      through the cannula trocar. Second puncture can be done through right or left iliac fossae.
      In groups GPL and GPS , the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5
      mg/kg) or the same volume of normal saline, for intraperitoneal administration. This ensures
      the surgeon and the anaesthesiologist are blind to the patient's group. The solution to be
      instilled will be splashed under the right diaphragmatic area by the surgeon and complete the
      procedure. At the end of the procedure, the patient will be placed back from trendelenburg
      position. In groups GPL and GPS , a pulmonary recruitment maneuver will be done and consist
      of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The
      anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds. In
      group GC CO2 will be removed by passive exsufflation through the port site and gentle
      abdominal pressure will be applied to evacuate the residual gas. Residual neuromuscular block
      is antagonized with atropine 1.2 mg and neostigmine 2.5 mg and extubation will be done
      according to extubation criteria. In the recovery room, patient will be asked about
      post-operative pain and it'll be controlled using Meperidine 1 mg/ kg and given by a nurse
      who is unaware of the nature of the intraoperative analgesia. Then, the patient is discharged
      to the ward according to the standard criteria. In the ward, patient will be asked to fulfill
      a questionnaire at 6, 8 and 10 hours postoperative using the visual analogue score (VAS) of
      pain severity. The patients were asked to complete a 10-cm linear analogue scale for shoulder
      pain, which ranged from 0 for no pain at all to 10 for the worst pain imaginable. Patients
      were questioned as to presence of Side effects (nausea, vomiting).

      Possible Risk Pneumothorax , Local anaesthetic toxicity : CNS depression (lightheadedness and
      dizziness, difficulty focusing, tinnitus, confusion, and circumoral numbness) , excitation (
      tremors tonic-clonic convulsions) , respiratory depression and cardiac dysrhythmias .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Postoperative pain measuring 6 hours postoperative
time frame: 6 hours post-oprative
description: post-operative pain measured using Visual Analogue Scale ,The patients were asked to complete a 10-cm linear analogue scale for shoulder pain, which ranged from 0 for no pain at all to 10 for the worst pain imaginable
measure: Post-operative Pain measuring Visual analogue scale 8 and 10 hour
time frame: 8 , 10 Hours Post-operative
description: questionnaire will done for the patient at 8, 10 hour using VAS
measure: Post-operative Nausea and Vomitting
time frame: 2 hours
description: questionnaire
arm group label: group of Pulmonary recruitment & Intraperitoneal libocai
arm group type: Active Comparator
arm group label: Group of Intraperitoneal lidocaine
arm group type: Active Comparator
arm group label: Group of pulmonary recruitment
arm group type: Active Comparator
arm group label: group receive passive exsufflation through port
arm group type: No Intervention
intervention type: Drug
intervention name: Intraperitoneal lidocaine
description: the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5 mg/kg) or the same volume of normal saline, for intraperitoneal administration. The solution to be instillated will be splashed under the right diaphragmatic area by the surgeon and complete the procedure.
arm group label: Group of Intraperitoneal lidocaine
intervention type: Procedure
intervention name: Pulmonary Recruitment
description: pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The anestheiologist hold the fifth positive pressure inflation for approximately 5 seconds
arm group label: Group of pulmonary recruitment
intervention type: Combination Product
intervention name: Combined intraperitoneal lidocaine and pulmonary recruitment maneuver
description: the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5 mg/kg) or the same volume of normal saline, for intraperitoneal administration. The solution to be instillated will be splashed under the right diaphragmatic area by the surgeon and complete the procedure before the recovery of the patient pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The anestheiologist hold the fifth positive pressure inflation for approximately 5 seconds
arm group label: group of Pulmonary recruitment & Intraperitoneal libocai
criteria: 
gender: Female
gender based: Yes
gender description: as the selected surgery is diagnostic laparoscopy done only for female as this type of surgery there will be no source of pain other than abdominal distension
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sherin Refaat
investigator title: lecturer of Anesthiology at faculty of medicine Cairo univeristy
mesh term: Abdominal Pain
mesh term: Lidocaine