Intraperitoneal Ketamine Versus Bupivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy

NCT06807554 | Completed Early Phase 1

• 1 other identifier: Liaquat National Hospital
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The intraperitoneal approach is used in anesthesia to manage the pain associated with abdominal procedures. Few studies have been conducted comparing intraperitonela ketamine with bupivacaine for pain control in laparoscopic cholecystectomy (LC) patients. To compare effect of intraperitoneal ketamine versus bupivacaine for postoperative pain control after LC. Department of Anesthesiology, Critical Care and Pain Management, Liaquat National Hospital and Medical College, Karachi. Group K received ketamine whereas Group B received bupivacaine. In Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon. In Group B, bupivacaine 2mg/kgdiluted in normal saline to a total volume of 40ml was administered. Tramadol 1.5 mg/kg to a maximum of 100 mg IV was given as rescue analgesia. The pain was assessed using a numeric rating scale (NRS) with zero being no pain to ten being the worst possible pain. Pain was assessed using NRS at 0 hour (immediate postoperative period), 2 hour, 4 hour, 6 hour and 12 hours postoperatively.

Conditions

Laparoscopic Cholecystectomy Surgery

Keywords

Laparoscopic surgery; Ketamine; Bupivacaine; Intraperitoneal instillation; Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• pain status

  The pain was assessed using a numeric rating scale (NRS) with zero being no pain to ten being the worst possible pain. Pain was assessed using NRS at 0 hour (immediate postoperative period), 2 hour, 4 hour, 6 hour and 12 hours postoperatively.

  2 hour, 4 hour, 6 hour and 12 hours postoperatively.

Study Arms (2)

Group K

EXPERIMENTAL

In Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon, 20 ml before starting gall bladder dissection over the surgical site and liver while remaining 20 ml at the end of procedure after securing haemostasis over gall bladder bed and liver.

Drug: Ketamine

Group B

ACTIVE COMPARATOR

In Group B, bupivacaine 2mg/kgdiluted in normal saline to a total volume of 40ml .

Drug: Bupivacaine

Interventions

Ketamine DRUG

In Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon, 20 ml before starting gall bladder dissection over the surgical site and liver while remaining 20 ml at the end of procedure after securing haemostasis over gall bladder bed and liver.

Group K

Bupivacaine DRUG

In Group B, bupivacaine at a dose of 2 mg/kg was diluted in normal saline to a total volume of 40 ml. The administration was performed by the surgeon in two stages: the first 20 ml was instilled before starting the gall bladder dissection, applied over the surgical site and liver, while the remaining 20 ml was instilled at the end of the procedure after achieving hemostasis, applied over the gall bladder bed and liver.

Also known as: Active compitator

Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of age 20-70 years
• Patients of either gender
• Patients planned to undergo elective LC

You may not qualify if:

• Patients known to allergic to study drugs
• Patients with chronic pain conditions
• Patients taking chronic pain medications
• Patients having psychiatric illness
• Patients weighing more than 80 kg,
• Emergency surgery and/or converted to open cholecystectomy

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

Study Sites (1)

Liaquat National Hospital

Karachi, Sindh, 75300, Pakistan

Location

Related Publications (3)

• Ziaei P, Kargar S, Dehghan MH, Madadizadeh F, Jamshidi HR. Clinical Trial of Intraperitoneal Administration of Ketamine Combined with Bupivacaine on Pain Status after Laparoscopic Cholecystectomy. Journal of Shahid Sadoughi University of Medical Sciences. 2022.

  BACKGROUND

• Mostafa, R.H. and Mekki, Y.M.H., 2018. Comparative evaluation of intraperitoneal bupivacaine and bupivacaine ketamine combined with lung recruitment for reducing postoperative shoulder pain in laparoscopic cholecystectomy. Egyptian Journal of Anaesthesia, 34(4), pp.159-164.

  BACKGROUND

• Moharari RS, Hadavi M, Pourfakhr P, Najafi A, Etezadi F, Khajavi MR. Evaluation of the postoperative analgesic efficacy of intraperitoneal ketamine compared with bupivacaine in laparoscopic cholecystectomy. Arch Anesthesiol Crit Care. 2016;2(1):146-9.

  BACKGROUND

MeSH Terms

Interventions

Ketamine; Bupivacaine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: January 1, 2022
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)