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

The Efface of Ketamine vs. Lidocaine in the Management of Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

This prospective interventional study conducted at Liaquat National Hospital and Medical College compared the analgesic efficacy of ketamine and lidocaine in managing postoperative pain after laparoscopic cholecystectomy. Total of 76 ASA I-II patients were randomly assigned into two equal groups (Group K: Ketamine, Group L: Lidocaine) using a sealed-envelope method in a double-blind, placebo-controlled design. Standard anesthesia with propofol, isoflurane, and atracurium was administered, and all patients received postoperative diclofenac sodium and ondansetron. Pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours postoperatively. The study aimed to compare the pain-relieving effects of ketamine and lidocaine, contributing to improved strategies for postoperative pain management following laparoscopic cholecystectomy.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: IV ketamine 0.5 mg/kg; Drug: IV Lidocain 60 mg/kg

Detailed Description

Effective postoperative pain management is essential for promoting patient recovery, reducing stress response, and improving overall outcomes following laparoscopic cholecystectomy. This prospective interventional study was conducted at Department of Anesthesiology at Liaquat National Hospital and Medical College to compare the analgesic efficacy of intravenous ketamine and lidocaine in managing postoperative pain among patients undergoing elective laparoscopic cholecystectomy.

A total of 76 ASA grade I and II patients with uncomplicated symptomatic gallstone disease were enrolled after obtaining written informed consent and ethical approval. Using a sealed-envelope randomization method, patients were divided into two equal groups: Group K (n=38) received ketamine, and Group L (n=38) received lidocaine. The study followed a double-blinded, placebo-controlled design to ensure unbiased assessment. Patients with ASA grade III-V, chronic pain, psychiatric illness, pregnancy or lactation, major hepatic, renal, or cardiovascular dysfunction, or a recent history of opioid or NSAID use were excluded.

All participants underwent standard preoperative preparation, including overnight fasting and pre-anesthetic evaluation. General anesthesia was induced with propofol and atracurium and maintained with isoflurane. Standard intraoperative monitoring of pulse rate, blood pressure, ECG, SpO₂, and end-tidal CO₂ was performed. Following surgery, residual neuromuscular blockade was reversed with neostigmine. All patients received intravenous diclofenac sodium every 8 hours for baseline analgesia and ondansetron to prevent postoperative nausea and vomiting.

Pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours postoperatively. Patients who reported pain received intravenous Kinz 5 mg as rescue analgesia, with timing recorded by nursing staff.

This study provided valuable insight into the comparative analgesic effects of ketamine and lidocaine for postoperative pain control following laparoscopic cholecystectomy, emphasizing their potential role in multimodal analgesia protocols to enhance patient comfort and recovery.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Liaquat National Hospital, Anesthesiology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketamine Group; The ketamine dose was calculated as 0.5 mg/kg of body weight, diluted with normal saline to a total volume of 10 mL, and administered intravenously as a stat dose during anesthesia reversal, following the completion of surgery.	Drug: IV ketamine 0.5 mg/kg; Patients in the Ketamine group received intravenous ketamine at a dose of 0.5 mg/kg body weight, diluted with normal saline to a total volume of 10 mL. The prepared solution was administered as a single (stat) intravenous injection at the time of anesthesia reversal, immediately after completion of laparoscopic cholecystectomy. The drug was administered under aseptic precautions by an anesthetist who was blinded to group allocation. All patients received standard postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline analgesia and ondansetron 4 mg IV for nausea prevention. Postoperative pain intensity was recorded at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients reporting significant pain were administered intravenous Kinz 5 mg as rescue analgesia, and the timing of administration was documented.
Active Comparator: Lidocaine Group; A total of 3 mL of 2% lidocaine was 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 completion of surgery.	Drug: IV Lidocain 60 mg/kg; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Liaquat National Hospital & Medical College
• Investigators: Principal Investigator: Mustafa Hussain Imam, MBBS, Liaquat National Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Actual): August 20, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Pain; Pain; Ketamine; Anesthesia; Lidocaine; Laparoscopic Cholecystectomy; Pain Management; Analgesia; Visual Analogue Scale (VAS)
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pain, Postoperative; Agnosia; Organic Chemicals; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Ketamine
• Other Study ID Numbers: 1097-2024-LNH-ERC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No