Clinical trial NCT06966596: Low-Dose Ketamine Infusion for Post-Operative Pain in Patients Undergoing Laparoscopic Cholecyctectomy
Official title: Effect of Low-Dose Ketamine Infusion on Quality and Duration of Post-Operative Pain in Patients Undergoing Laparoscopic Cholecyctectomy Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Laparoscopic Cholecystectomy
Keywords: Cholelithiasis
Cholecystectomy
Laparoscopic surgery
Ketamine
Analgesia
Lead sponsor: Fazaia Ruth Pfau Medical College
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Post-pain assessment
timeFrame: pain status was monitored post-operatively at 0 hour, 2 hour, 4 hours, 6 hours, 12 hours and at 24 hours
Secondary outcomes:
measure: time to rescue analgesia
timeFrame: till 24 hours post-operatively
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Fazaia Ruth Pfau Medical College, PAF Hospital Base Faisal
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.