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

NCT ID: NCT06966596

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-03-31

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.

Conditions

Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.

Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery.

Group Type: EXPERIMENTAL

Ketamine only

Intervention Type: DRUG

Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery. W

Control Group B

Control group received normal saline intravenously at an equivalent infusion rate

Group Type: PLACEBO_COMPARATOR

Placebo Normal Saline (NS)

Intervention Type: OTHER

Control group received normal saline to maintain double blinding

Interventions

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. W

Intervention Type: DRUG

Placebo Normal Saline (NS)

Control group received normal saline to maintain double blinding

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fazaia Ruth Pfau Medical College

OTHER

Sponsor Role: lead

Responsible Party

Syeda Hajrah Rehman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fazaia Ruth Pfau Medical College, PAF Hospital Base Faisal

Karachi, , Pakistan

Countries

Pakistan

References

Jain S, Nazir N, Mustafi SM. Preemptive low-dose intravenous ketamine in the management of acute and chronic postoperative pain following laparoscopic cholecystectomy: a prospective randomized control study. Med Gas Res. 2022 Oct-Dec;12(4):141-145. doi: 10.4103/2045-9912.337995.

Reference Type: BACKGROUND

PMID: 35435425 (View on PubMed)

Akturk R, Serinsoz S. Determining a Method to Minimize Pain After Laparoscopic Cholecystectomy Surgery. Surg Laparosc Endosc Percutan Tech. 2022 Aug 1;32(4):441-448. doi: 10.1097/SLE.0000000000001071.

Reference Type: BACKGROUND

PMID: 35797664 (View on PubMed)

Gin E, Lowen D, Tacey M, Hodgson R. Reduced Laparoscopic Intra-abdominal Pressure During Laparoscopic Cholecystectomy and Its Effect on Post-operative Pain: a Double-Blinded Randomised Control Trial. J Gastrointest Surg. 2021 Nov;25(11):2806-2813. doi: 10.1007/s11605-021-04919-0. Epub 2021 Feb 9.

Reference Type: BACKGROUND

PMID: 33565010 (View on PubMed)

Other Identifiers

FPRMC-IRB-2024-38

Identifier Type: -

Identifier Source: org_study_id