About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Fentanyl
DrugFentanyl 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
DrugKetamine 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Total analgesia consumption postoperatively.
Total Nalphuine consumption in milligrams, in the first 24 hours postoperatively.
Postoperative Numeric Rating Scale of pain
Postoperative Numeric Rating Scale of pain.( in post-anaesthesia care unit, half hour, 2, 6, 12, 18, 24 hours postoperatively)
Locations
Sponsors and contacts
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