Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy
- Conditions
- Post Operative Pain
- Interventions
- Other: Normal saline
- Registration Number
- NCT06281418
- Lead Sponsor
- Future University in Egypt
- Brief Summary
Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC.
- Detailed Description
Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Granisetron is frequently used as a premedication to avoid postoperative nausea and vomiting in patients who have undergone general anesthesia. The purpose of this study is evaluating the efficacy and tolerability of IP granisetron on postoperative pain control in patients undergoing LC
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- Patients who are scheduled to undergo elective LC.
- Adults (males and/or females) between the ages of 18-70 years old.
- Chronic pain other than cholelithiasis.
- Patients who received analgesics or sedatives 24 h before scheduled surgery.
- Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl <30ml/min)
- Previous allergic response to granisetron.
- Pregnancy and lactation
- Patients with communication problems, cognitive dysfunction, or psychological disorders
- Daily corticosteroid use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm Normal saline 2 ml IP normal saline (0.9 % NaCl) Intervention arm Granisetron 1 Mg/mL Intravenous Solution 2ml IP granisetron (1 mg/mL)
- Primary Outcome Measures
Name Time Method VAS score 2 hours, 4 hours, 8 hours, 12 hours, 24 hours Pain intensity: VAS score
- Secondary Outcome Measures
Name Time Method Time to analgesic request 24 hours Time to first rescue analgesic request
Quality of life (QoL) after laparoscopic cholecystectomy (LC) 3 months Gastrointestinal Quality of Life Index questionnaire for QOL assessment with calculation of the score; most desirable option: 4 points, least desirable option: 0 points and GIQLI score: sum of the point. GIQLI ranges from 0 to 80 with higher scores indicating a better quality of life.
Trial Locations
- Locations (1)
National Hepatology and Tropical Research Institute
🇪🇬Cairo, Egypt