Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain

NCT03241602 | Completed Phase 4 DMC

• 1 other identifier: N-61-2017
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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 .

Conditions

Decrease Post Laproscopy Shoulder and Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain measuring 6 hours postoperative

  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

  6 hours post-oprative

Secondary Outcomes (2)

• Post-operative Pain measuring Visual analogue scale 8 and 10 hour

  8 , 10 Hours Post-operative

• Post-operative Nausea and Vomitting

  2 hours

Study Arms (4)

group of Pulmonary recruitment & Intraperitoneal libocai

ACTIVE COMPARATOR

Combination Product: Combined intraperitoneal lidocaine and pulmonary recruitment maneuver

Group of Intraperitoneal lidocaine

ACTIVE COMPARATOR

Drug: Intraperitoneal lidocaine

Group of pulmonary recruitment

ACTIVE COMPARATOR

Procedure: Pulmonary Recruitment

group receive passive exsufflation through port

NO INTERVENTION

Interventions

Intraperitoneal lidocaine DRUG

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.

Group of Intraperitoneal lidocaine

Pulmonary Recruitment PROCEDURE

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

Group of pulmonary recruitment

Combined intraperitoneal lidocaine and pulmonary recruitment maneuver COMBINATION_PRODUCT

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

group of Pulmonary recruitment & Intraperitoneal libocai

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• American Society of Anesthesiology (ASA) physical status ≥ 3
• Allergy or hypersensitivity to amide type local anaesthetics;
• Pre-existing chronic pain disorders;
• Receiving opioids or tranquilizers for \> 1 week preoperatively;
• History of alcohol or drug abuse.
• If the operation included any interventional procedure or was converted to an open procedure, or had postoperative complications that could increase postoperative pain

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine CAIRO UNIVERISTY

Cairo, Egypt

Location

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anesthiology at faculty of medicine Cairo univeristy

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 7, 2017
• Study Start: August 15, 2017
• Primary Completion: October 28, 2017
• Study Completion: October 30, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

EG (1)