Low-Dose Ketamine Infusion for Post-Operative Pain in Patients Undergoing Laparoscopic Cholecyctectomy

Phase 1

Completed

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Drug: Ketamine only; Other: Placebo Normal Saline (NS)

• Registration Number: NCT06966596
• Lead Sponsor: Fazaia Ruth Pfau Medical College

Brief Summary

Following surgery, acute pain is a typical issue with a variety of implications. Surgeons, anesthesia specialists, and patients all desire effective pain management with the fewest possible adverse effects. At low dosages (\<0.3 mg/kg/hr) and large doses (\>1 mg/kg), ketamine is utilized as an analgesic and an anaesthetic. Ketamine at high dosages causes dissociative anaesthesia with little impact on breathing or airway reflexes. Although this medication is a powerful analgesic, its usage is restricted due to it leads to agitation and hallucinations during awakening. Nevertheless, it has a potent analgesic effect when administered at a subanesthetic dose, and ketamine's psychomimetic side effects are rare at these dosages. This study intended to examine the role of low-dose for post-operative pain control in patients undergoing LC, despite the fact that numerous studies have been conducted on the subject and that the results have been inconsistent.

Detailed Description

Most patients still stay overnight after a laparoscopic cholecystectomy (LC) due to post-operative pain, which continues to be the principal obstacle to early patient discharge. On the first postoperative day following laparoscopic procedures, patients may have mild to moderate postoperative pain, with decreased pain intensity in the shoulder area (from the subdiaphragmatic region), particularly intra-abdominal and local discomfort at the incision site. Because of its analgesic properties and cardiovascular stability, ketamine has been used extensively in anesthesia practice. It non-competitively blocks N-methyl-D-aspartate (NMDA) receptors. As an addition to multimodal perioperative pain management, ketamine has grown in favor in recent years. Ketamine at high dosages causes dissociative anaesthesia with little impact on breathing or airway reflexes. In a range of surgical procedures, low-dose ketamine infusions (\<0.3 mg/kg/hr) have demonstrated effectiveness in lowering pain scores and minimising the need for postoperative opioids. Regarding the reduction of pain and analgesic demand, ketamine has demonstrated conflicting effects. The study objective was to determine the effect of low-dose ketamine infusion on quality and duration of post-operative pain in patients undergoing laparoscopic in a tertiary care hospital.

Study Timeline

• Study Start: 2024-11-01
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-04
• Study First Submitted QC: 2025-05-04
• Study First Posted: 2025-05-13
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Patients of age 18 years or above of either gender
• Patients planned of elective laparoscopic choleycyctectomy

Exclusion Criteria

• Obese patients
• History of alcohol consumption and drug abusers
• Uncontrolled hypertension
• Uncontrolled diabetes
• Patients with chronic pain
• Patients allergic to study drugs
• Patients with neurological disorders
• Patients unable to understand scoring system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.	Ketamine only	Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery.
Control Group B	Placebo Normal Saline (NS)	Control group received normal saline intravenously at an equivalent infusion rate

Primary Outcome Measures

Name	Time	Method
Post-pain assessment	pain status was monitored post-operatively at 0 hour, 2 hour, 4 hours, 6 hours, 12 hours and at 24 hours	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 pain and 10 means worst pain.

Secondary Outcome Measures

Name	Time	Method
time to rescue analgesia	till 24 hours post-operatively	time to rescue analgesia was defined as time point at which patient was given rescue analgesia for pain score of 5 or above

Trial Locations

Locations (1)

Fazaia Ruth Pfau Medical College, PAF Hospital Base Faisal; 🇵🇰 Karachi, Pakistan