Postoperative Analgesia in Laparoscopic Gynecological Surgeries

Magnesium Sulfate Versus Sodium Bicarbonate as Adjuvants to Lidocaine 1% by Intraperitoneal Instillation for Postoperative Analgesics in Laparoscopic Gynecological Surgeries

The aim of this study is to compare intraperitoneal instillation of magnesium sulfate versus sodium bicarbonate as an adjuvant to lidocaine 1% , on reducing postoperative pain in laparoscopic gynecological surgeries.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Group M (lidocaine with Magnesium sulfate); Drug: Group B (lidocaine with Sodium bicarbonate); Drug: Group C (lidocaine with saline)

Detailed Description

Patients undergoing laparoscopic surgery experience postoperative pain especially in the abdomen, lower back, and shoulders, Relieving postoperative pain, especially with certain types of analgesic agents, may reduce postoperative morbidity and mortality. It is also important to prevent adverse events such as myocardial infarction, cardiac arrhythmia, ileus, and poor wound healing and pulmonary complications. There is evidence that the main source of pain after laparoscopic surgeries is the peritoneum . Due to CO2 insufflation constitutes the commonest means of creating the pneumoperitoneum. Co2pneumoperitoneum is known to cause systemic acidosis. Which is responsible for damaging of the mesothelial lining of the peritoneum and consequent peritoneal irritation . Moreover, the phrenic nerve could be damaged by the acidic environment The use of local anesthetics has been advocated as a method for reducing postoperative pain local anesthetic intraperitoneal administration has shown good effects on reducing postoperative pain in laparoscopic cholecystectomy and gynecological surgeries . intraperitoneal sodium bicarbonate instillation may neutralize effect of the acid milieu on peritoneal cavity and the phrenic nerve damage which consecutively will lead to a reduction of postoperative pain. Magnesium sulfate, a non-competitive NMDA antagonist, has been proven in animal and human being models to have antinociceptive properties. The antinociceptive effect of magnesium sulfate relieves chronic pain and it can also decrease the duration and intensity of postoperative pain.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mahmoud Hamza Abd elrady, M.B.B.Ch; Phone Number: 01020643396; Email: mh401022@gmail.com
• Study Contact Backup: Name: Noha Hassan Abdelghany, M.D.; Phone Number: 01069009221; Email: noha@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age 18:60years
• patients undergoing laparoscopic gynecological surgeries,
• ASA 1&2

Exclusion Criteria:

• patient dissatisfaction for participating in the study
• opioid use within 24 hr before the study
• allergy to the drugs used in the study and alcohol use
• chronic pain syndrome.
• neurological disease.

• steroid treatment

  • conversion of laparoscopic surgery to open surgery
  • use a drain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group M (Magnesium sulfate); a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine with magnesium sulfate 50 mg/kg (maximum 2g) will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.	Drug: Group M (lidocaine with Magnesium sulfate); a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine with magnesium sulfate 50 mg/kg (maximum 2g) will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.
Experimental: Group B (Sodium bicarbonate); a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine with 50 ml 4.2% sodium bicarbonate will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.	Drug: Group B (lidocaine with Sodium bicarbonate); a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine with 50 ml 4.2% sodium bicarbonate will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.
Active Comparator: Group C; a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.	Drug: Group C (lidocaine with saline); a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first rescue analgesia	The first request for analgesia will be recorded by the nurse, and in case of pain in VAS more than 3, 1 gm of paracetamol will be administrated as a rescue analgesic if failed fentanyl 100mic will be added	24 hour postoperative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Essam Ezzat Abdel Hakeem, M.D., Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Laparoscopic gynecological surgeries
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Lidocaine; Magnesium Sulfate
• Other Study ID Numbers: Post laparoscopy analgesia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No