Intraperitoneal Ketamine Versus Fentanyl as Adjuvants to Bupivacaine in Laparoscopic Cholecystectomy

Sponsor
Assiut University
Study ID
NCT07670052
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
20 Years - 50 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jun 26, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fentanyl
    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.
  • Experimental: ketamine
    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.

Primary Outcome Measure

Time of first analgesic request. [ Time Frame: 24 hours ]

Central Contacts

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