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

NCT07248384 | Completed Phase 1

• 1 other identifier: 1097-2024-LNH-ERC
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

Ketamine; Lidocaine; Postoperative Pain; Pain; Laparoscopic Cholecystectomy; Analgesia; Visual Analogue Scale (VAS); Anesthesia; Pain Management

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)

Ketamine Group

ACTIVE COMPARATOR

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

Lidocaine Group

ACTIVE COMPARATOR

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

Interventions

IV ketamine 0.5 mg/kg DRUG

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.

Ketamine 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: Yes
• 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)

Liaquat National Hospital, Anesthesiology Department

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mustafa Hussain Imam, Mbbs

  Liaquat National Hospital

  PRINCIPAL INVESTIGATOR

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: July 15, 2023
• Primary Completion: August 20, 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)