The Efface of Lidocaine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy

NCT07248332 | Completed Phase 1

• 1 other identifier: 1095-2024-LNH-ERC
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective interventional study was carried out at Liaquat National Hospital and Medical College to evaluate and compare the postoperative analgesic effects of intravenous lidocaine and magnesium sulphate in patients undergoing laparoscopic cholecystectomy. A total of 168 ASA I-II patients were enrolled and randomly allocated into two groups of 84 participants each (Group L: Lidocaine, Group M: Magnesium Sulphate) using a sealed-envelope randomization technique in a double-blind, placebo-controlled design. All patients received standardized general anesthesia with propofol, isoflurane, and atracurium, and routine postoperative care included intravenous diclofenac sodium and ondansetron. Postoperative pain was measured at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS) to assess and compare the efficacy and duration of analgesia between the two groups. The study aimed to provide insight into the relative analgesic performance of lidocaine and magnesium sulphate, supporting improved pain management strategies following laparoscopic cholecystectomy.

Conditions

Laparoscopic Cholecystectomy Surgery; Postoperative Pain Management

Keywords

Lidocaine; Magnesium Sulphate; Postoperative Pain; Laparoscopic Cholecystectomy; Visual Analogue Scale (VAS); analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score

  Postoperative pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours after surgery to evaluate and compare the effectiveness and duration of analgesia between the ketamine and lidocaine groups. These time intervals were selected to monitor both the early and late postoperative pain responses during the first 24 hours of recovery.

  Postoperative pain was assessed at the 1st, 6th, 12th, and 24th hours.

Study Arms (2)

Magnesium Sulphate Group

ACTIVE COMPARATOR

The magnesium sulfate dose was prepared as 2 mg, diluted with normal saline to a total volume of 10 mL, and administered intravenously as a single stat dose at the time of anesthesia reversal after completion of surgery.

Drug: IV 2mg of Magnesium Sulphate

Lidocaine Group

ACTIVE COMPARATOR

A total of 3 mL of 2% lidocaine was combined with 7 mL of normal saline to prepare a 10 mL solution, which was given intravenously as a single stat dose at the time of anesthesia reversal immediately after the surgery was completed.

Drug: IV Lidocain 60 mg/kg

Interventions

IV 2mg of Magnesium Sulphate DRUG

Patients in the magnesium sulfate group received 2 mg of the drug, which was diluted with normal saline to a total volume of 10 mL and administered intravenously as a single stat dose at the time of anesthesia reversal following completion of laparoscopic cholecystectomy. The injection was performed under aseptic conditions by an anesthetist who was blinded to group assignment. All participants received routine postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline pain control and intravenous ondansetron 4 mg to prevent nausea. Postoperative pain intensity was measured using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours. Patients experiencing significant pain were given intravenous Kinz 5 mg as rescue analgesia, and the timing of administration was recorded for documentation.

Magnesium Sulphate Group

IV Lidocain 60 mg/kg DRUG

Patients in the Lidocaine group received 3 mL of 2% lidocaine, diluted with 7 mL of normal saline to prepare a 10 mL solution, which was administered intravenously as a stat dose at the time of anesthesia reversal, immediately after surgery. The intervention was given using the same protocol and blinding method as the Ketamine group to maintain uniformity. Similar to Group K, all patients received standard postoperative medications, including IV diclofenac sodium and ondansetron. Pain assessment was performed using the VAS scale at 1, 6, 12, and 24 hours postoperatively. Patients requiring additional pain relief were given IV Kinz 5 mg as rescue analgesia, with the time of each administration noted.

Lidocaine Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years. ASA physical status I-II. Elective laparoscopic cholecystectomy planned under general anesthesia. Normal baseline renal, hepatic, and coagulation profile. Able to give informed consent and communicate pain scores. Negative pregnancy test for women of childbearing age

You may not qualify if:

• ASA III-V patients. Allergy or hypersensitivity to ketamine, lidocaine, or related drugs. History of psychiatric illness or substance abuse. Chronic use of opioids, benzodiazepines, or MAO inhibitors. Pregnant or breastfeeding women. Chronic pain disorders or use of analgesics within 7 days pre-op. Major hepatic, renal, or cardiovascular dysfunction. History of myopathy or seizure disorders. Patients with atrioventricular block or on calcium-channel blockers. Conversion to open cholecystectomy during surgery. Inability to understand or report pain postoperatively.

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

Study Sites (1)

Anesthesiology Department Liaquat National Hospital and Medical College

Karachi, Sindh, 78400, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Mustafa Hussain Imam, MBBS

  Liaquat National Hospital

  PRINCIPAL INVESTIGATOR

• Ali Asgher, Mbbs, FCPS

  Liaquat National Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mustafa Hussain Imam

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: January 18, 2024
• Primary Completion: September 15, 2025
• Study Completion: October 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)