Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03241602
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Sherin Refaat, Cairo University

Tracking Information
First Submitted Date  ICMJE August 3, 2017
First Posted Date  ICMJE August 7, 2017
Last Update Posted Date January 25, 2018
Actual Study Start Date  ICMJE August 15, 2017
Actual Primary Completion Date October 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
Postoperative pain measuring 6 hours postoperative [ Time Frame: 6 hours post-oprative ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03241602 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
  • Post-operative Pain measuring Visual analogue scale 8 and 10 hour [ Time Frame: 8 , 10 Hours Post-operative ]
    questionnaire will done for the patient at 8, 10 hour using VAS
  • Post-operative Nausea and Vomitting [ Time Frame: 2 hours ]
    questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain
Official Title  ICMJE Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain in Patient Undergoing Diagnostic Gynacological Laproscopy. A Randomized Controlled Trial
Brief Summary

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 .

Detailed Description

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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Decrease Post Laproscopy Shoulder and Abdominal Pain
Intervention  ICMJE
  • Drug: Intraperitoneal lidocaine
    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.
  • Procedure: Pulmonary Recruitment
    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
  • Combination Product: Combined intraperitoneal lidocaine and pulmonary recruitment maneuver
    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
Study Arms  ICMJE
  • Active Comparator: group of Pulmonary recruitment & Intraperitoneal libocai
    Intervention: Combination Product: Combined intraperitoneal lidocaine and pulmonary recruitment maneuver
  • Active Comparator: Group of Intraperitoneal lidocaine
    Intervention: Drug: Intraperitoneal lidocaine
  • Active Comparator: Group of pulmonary recruitment
    Intervention: Procedure: Pulmonary Recruitment
  • No Intervention: group receive passive exsufflation through port
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2017)
88
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 30, 2017
Actual Primary Completion Date October 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female patients, aged 18-45 years scheduled for diagnostic Gynaecologic laparoscopy.
  2. American Society of Anesthesiology physical status 1 or 2.

Exclusion Criteria:

  1. American Society of Anesthesiology (ASA) physical status ≥ 3
  2. Allergy or hypersensitivity to amide type local anaesthetics;
  3. Pre-existing chronic pain disorders;
  4. Receiving opioids or tranquilizers for > 1 week preoperatively;
  5. History of alcohol or drug abuse.
  6. If the operation included any interventional procedure or was converted to an open procedure, or had postoperative complications that could increase postoperative pain
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility 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
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03241602
Other Study ID Numbers  ICMJE N-61-2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sherin Refaat, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP