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

L

Liaquat National Hospital & Medical College

Status and phase

Completed
Phase 1

Conditions

Laparoscopic Cholecystectomy Surgery
Postoperative Pain Management

Treatments

Drug: IV 2mg of Magnesium Sulphate
Drug: IV Lidocain 60 mg/kg

Study type

Interventional

Funder types

Other

Identifiers

NCT07248332
1095-2024-LNH-ERC

Details and patient eligibility

About

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.

Full description

Optimal management of postoperative pain is crucial for enhancing recovery, minimizing stress responses, and promoting better outcomes after laparoscopic cholecystectomy. This prospective interventional study was carried out in the Department of Anesthesiology at Liaquat National Hospital and Medical College to compare the analgesic effects of intravenous lidocaine and magnesium sulphate in patients undergoing elective laparoscopic cholecystectomy.

A total of 168 patients classified as ASA I-II with uncomplicated symptomatic gallstones were enrolled after obtaining ethical approval and written informed consent. Participants were randomly assigned into two equal groups of 84 patients each (Group L: Lidocaine, Group M: Magnesium Sulphate) using a sealed-envelope technique. The study employed a double-blind, placebo-controlled design to ensure unbiased evaluation. Patients with ASA III-V, chronic pain disorders, psychiatric conditions, pregnancy or breastfeeding, major hepatic, renal, or cardiovascular disease, or recent use of opioids or NSAIDs were excluded from the study.

All patients underwent standard preoperative assessment, including overnight fasting and anesthetic evaluation. General anesthesia was induced with propofol and atracurium and maintained with isoflurane. Intraoperative monitoring included heart rate, blood pressure, ECG, oxygen saturation, and end-tidal CO₂. Residual neuromuscular blockade was reversed with neostigmine at the end of surgery. Postoperative care included intravenous diclofenac sodium every 8 hours for baseline analgesia and ondansetron for prevention of nausea and vomiting.

Postoperative pain intensity was recorded at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients experiencing significant pain were administered intravenous Kinz 5 mg as rescue analgesia, and the timing was documented by nursing staff.

This study provided important information on the comparative efficacy of lidocaine and magnesium sulphate for postoperative pain management, highlighting their potential role in multimodal analgesic strategies to improve patient comfort and recovery following laparoscopic cholecystectomy.

Enrollment

168 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

168 participants in 2 patient groups

Magnesium Sulphate Group
Active Comparator group
Description:
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.
Treatment:
Drug: IV 2mg of Magnesium Sulphate
Lidocaine Group
Active Comparator group
Description:
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.
Treatment:
Drug: IV Lidocain 60 mg/kg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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