Intraperitoneal Ketamine Versus Fentanyl as Adjuvants to Bupivacaine in Laparoscopic Cholecystectomy

NCT07670052 | Not Yet Recruiting Phase 4

• 1 other identifier: 04-2026-201752
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

Laparoscopic cholecystectomy is the standard surgical treatment for gallbladder stones; however, the origin of pain after LC is multifactorial and complex in nature. Pain arising from incision sites is parietal pain, whereas pain from the gall bladder bed is mainly visceral in nature, and shoulder pain is mainly referred owing to the residual carbon dioxide irritating the diaphragm. Intraperitoneal administration of local anesthetics has been shown to improve postoperative pain control and reduce the need for systemic analgesics. The addition of adjuvant agents such as fentanyl or ketamine may further enhance analgesic efficacy. This randomized double-blind study aims to compare the effectiveness of intraperitoneal ketamine versus fentanyl as adjuvants to bupivacaine in reducing postoperative pain and analgesic requirements following laparoscopic cholecystectomy.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Time of first analgesic request.

  The primary outcome of the study is comparison of the post-operative analgesic effect regarding the time to first analgesic request of fentanyl versus Ketamine as adjuvants to bupivacaine in patients undergoing laparoscopic cholecystectomy

  24 hours

Secondary Outcomes (2)

• Total analgesia consumption postoperatively.

  24 hours

• Postoperative Numeric Rating Scale of pain

  24 hours postoperatively.

Study Arms (2)

Fentanyl

EXPERIMENTAL

Fentanyl used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose of 1 ug/kg is commonly added to the local anesthetic solution. Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol.

Drug: Fentanyl

ketamine

EXPERIMENTAL

Ketamine used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose of 0.25 mg/kg is commonly added to the local anesthetic solution. Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol.

Drug: Ketamine

Interventions

Fentanyl DRUG

Fentanyl used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose of 1 ug/kg is commonly added to the local anesthetic solution. Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol.

Fentanyl

Ketamine DRUG

Ketamine used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose of 0.25 mg/kg is commonly added to the local anesthetic solution. Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol.

ketamine

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of age 20-50 years
• Patients of either gender
• Patients planned to undergo elective LC.
• Patients have I-II of the American Society of Anaesthesiologists (ASA)

You may not qualify if:

• Patient's refusal.
• body mass index (BMI) ≥40 kg/m2.
• History of hypersensitivity to the drugs being evaluated
• Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.
• chronic use of opioids and opioid addiction
• Patients with acute cholecystitis or converted to open surgery.
• Carcinoma of gall bladder
• Pregnant female
• Bleeding disorders

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• Mannam R, Sankara Narayanan R, Bansal A, Yanamaladoddi VR, Sarvepalli SS, Vemula SL, Aramadaka S. Laparoscopic Cholecystectomy Versus Open Cholecystectomy in Acute Cholecystitis: A Literature Review. Cureus. 2023 Sep 21;15(9):e45704. doi: 10.7759/cureus.45704. eCollection 2023 Sep.

  PMID: 37868486 BACKGROUND

• Kuhry E, Jeekel J, Bonjer HJ. Effect of laparoscopy on the immune system. Semin Laparosc Surg. 2004 Mar;11(1):37-44. doi: 10.1177/107155170401100107.

  PMID: 15094977 BACKGROUND

• Kahokehr A, Sammour T, Soop M, Hill AG. Intraperitoneal use of local anesthetic in laparoscopic cholecystectomy: systematic review and metaanalysis of randomized controlled trials. J Hepatobiliary Pancreat Sci. 2010 Sep;17(5):637-56. doi: 10.1007/s00534-010-0271-7.

  PMID: 20393755 BACKGROUND

• Khodorova A, Navarro B, Jouaville LS, Murphy JE, Rice FL, Mazurkiewicz JE, Long-Woodward D, Stoffel M, Strichartz GR, Yukhananov R, Davar G. Endothelin-B receptor activation triggers an endogenous analgesic cascade at sites of peripheral injury. Nat Med. 2003 Aug;9(8):1055-61. doi: 10.1038/nm885. Epub 2003 Jun 29.

  PMID: 12847519 BACKGROUND

• E. E. F. Mohamed, K. M. Hassan, W. A. Aboelwafa, and I. M. Ahmed, "Analgesia for Postoperative Pain in Laparoscopic Surgery: Review Article," Egypt. J. Hosp. Med., vol. 87, no. 1, 2022, doi: 10.21608/ejhm.2022.229353.

  BACKGROUND

• Laisalmi M, Koivusalo AM, Valta P, Tikkanen I, Lindgren L. Clonidine provides opioid-sparing effect, stable hemodynamics, and renal integrity during laparoscopic cholecystectomy. Surg Endosc. 2001 Nov;15(11):1331-5. doi: 10.1007/s004640090126. Epub 2001 Aug 16.

  PMID: 11727145 BACKGROUND

• Narchi P, Benhamou D, Fernandez H. Intraperitoneal local anaesthetic for shoulder pain after day-case laparoscopy. Lancet. 1991 Dec 21-28;338(8782-8783):1569-70. doi: 10.1016/0140-6736(91)92384-e.

  PMID: 1683981 BACKGROUND

• Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg. 2006 Sep;103(3):682-8. doi: 10.1213/01.ane.0000226268.06279.5a.

  PMID: 16931681 BACKGROUND

• Hong E, Jeong DH, Kang HY, Choi JH, Park SW. The effect of preemptive intravenous ketamine on postoperative pain in patients undergoing arthroscopic rotator cuff repair with intra-articular ropivacaine injection Anesth Pain Med. 2003;11:71-75

  BACKGROUND

• Glick JL, Christensen T, Park JN, McKenzie M, Green TC, Sherman SG. Stakeholder perspectives on implementing fentanyl drug checking: Results from a multi-site study. Drug Alcohol Depend. 2019 Jan 1;194:527-532. doi: 10.1016/j.drugalcdep.2018.10.017. Epub 2018 Nov 13.

  PMID: 30551090 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tarek Mo Essa Tohamy

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek Mo Essa Tohamy

CONTACT

+201027342291; tarekessa970@gmail.com

Eman Ah Ismail, MD

CONTACT

+20 1060223750; emanismail@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: An independent anesthesiologist randomly divided the patients into 42 groups of patients each using computer-generated random numbers fentanyl group and ketamine group (Group F and Group K). We discreetly placed the randomization results in envelopes until the end of the study. Both ketamine and fentanyl are colorless liquids, and they were digitally encoded so that the researchers who were responsible for postoperative follow-up and data processing were blinded to the group allocation during the whole study period. All patients were also blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Instillation technique Intraperitoneal instillation of study drugs will be done by the operating surgeon through laparoscopic ports guided by surgical camera after the removal of the gall bladder, onto the gall bladder fossa, under the diaphragm, on the liver bed and patient position was changed to 15° 20° Trendelenburg position for 10 min. Intraperitoneal Instillation: The mixture of bupivacaine and fentanyl or Ketamine is instilled into the peritoneal cavity after securing hemostasis over the gall bladder bed. Study drug doses: Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol. Fentanyl group (42 patients): When used as an adjuvant to bupivacaine, a dose of 1 ug/kg is commonly added to the local anaesthetic solution. Ketamine group (42 patients): When used as an adjuvant to bupivacaine, a dose of 0.25 mg/kg is commonly added to the local anesthetic solution.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share