Post Operative Pain
Conditions
Keywords
laparoscopic, post-operative pain, serotonin 5HT3 receptor antagonist
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
Interventions
2mL intraperitoneal adminstration of granisetron (1 mg/mL)
OTHERNormal saline
2 ml IP normal saline (0.9% NaCl)
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled to undergo elective LC. * Adults (males and/or females) between the ages of 18-70 years old.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS score | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours | Pain intensity: VAS score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed