Effect of Intravenous Low-Dose Ketamine Infusion With Intravenous Lignocaine Infusion on Post-Operative Pain in Patients Undergoing Laparoscopic Choleysystectomy Under General Anesthesia

NCT06964555 | Completed Phase 4 DMC

• 1 other identifier: FRPMC-IRB-2024-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To determine the effect of low-dose ketamine versus lignocaine on post-operative pain in patients undergoing LC under general anesthesia in a tertiary care hospital. Sample Selection: Patients of both the gender of age at least 18 years, planned for elective LC with ASA grade I-II were included. Patients with obesity, history of alcohol consumptions, drug abusers, uncontrolled hypertension and diabetics, with chronic pain, allergic to study drugs, having neurological disorders, unable to understand pain scoring system and converted to open LC were excluded.

Conditions

Cholelithiases

Keywords

Cholelithiases; Cholecystectomy; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Post operative Pain

  Pain was assessed using Numeric Rating Scale which is a ten point scoring scale ranging from 0-10 for ranking pain where 0 means no and 10 means worst pain.

  24 hours

Secondary Outcomes (2)

• Time to rescue analgesia

  24 hours

• Wound Closure

  End of Surgery

Study Arms (2)

Group L

ACTIVE COMPARATOR

Just before the skin incision intravenous lignocaine was given.

Drug: Intravenous lignocaine

Group K

EXPERIMENTAL

Just before the skin incision, intravenous ketamine was given

Drug: Intravenous Ketamine Infusions

Interventions

Intravenous Ketamine Infusions DRUG

Ketamine group received ketamine at 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery.

Group K

Intravenous lignocaine DRUG

IV Lignocaine was given at the rate of 1 mg/kg/hr.

Group L

Eligibility Criteria

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

You may qualify if:

• Patients of both the gender of age at least 18 years
• Patients planned for elective LC
• Patients with ASA grade I-II were included.

You may not qualify if:

• Patients with obesity,
• Patients with history of alcohol consumptions, uncontrolled hypertension and diabetics,
• Drug abusers
• Patients with chronic pain
• Patients allergic to study drugs
• Patients having neurological disorders or unable to understand pain scoring system
• Patients converted to open LC

Sponsors & Collaborators

• Fazaia Ruth Pfau Medical College: lead

Study Sites (1)

Fazaia Ruth Pfau Medical College

Karachi, Sindh, 75510, Pakistan

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: January 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)