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

NCT07248384 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-11-25

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Liaquat National Hospital & Medical College

    lead OTHER

Principal Investigators

  • Mustafa Hussain Imam, Mbbs · Liaquat National Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2025-08-20
Completion
2025-10-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07248384 on ClinicalTrials.gov