Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy

Post Operative Pain Clinical Trial

Official title:

Postoperative Pain Management Following Laparoscopic Cholecystectomy- Intraperitoneal Granisetron

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281418
• Other study ID #: 5-24
• Status: Recruiting
• Phase: Phase 3
• Start date: February 29, 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Future University in Egypt
• Contact: Hoda Mohamed Bayoumi, Bachelor's
• Phone: 01126143971
• Email: hoda.bayoumy[@]fue.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 preoperative oral administration of IP granisetron on postoperative pain control in patients undergoing LC

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 vortioxetine, and granisetron.

• Pregnancy and lactation

• Patients with communication problems, cognitive dysfunction, or psychological disorders

• Daily corticosteroid use

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Granisetron 1 Mg/mL Intravenous Solution
2mL intraperitoneal adminstration of granisetron (1 mg/mL)

Other:
• Normal saline
2 ml IP normal saline (0.9% NaCl)

Locations

Country	Name	City	State
Egypt	National Hepatology and Tropical Research Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS score	Pain intensity: VAS score	2 hours, 4 hours, 8 hours, 12 hours, 24 hours
Secondary	Time to analgesic request	Time to first rescue analgesic request	24 hours
Secondary	Quality of life (QoL) after laparoscopic cholecystectomy (LC)	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.	3 months