Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

Cholecystitis Clinical Trial

Official title:

Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468685
• Other study ID #: 12-2020
• Status: Completed
• Phase: Phase 2
• Start date: July 15, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: January 2021
• Source: National Hepatology & Tropical Medicine Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal invasiveness, less post-operative pain and early recovery when compared to the open conventional cholecystectomy. However, patients who have undergone LC still complain of postoperative pain. It has been reported that ondansetron produces numbness when injected under the skin and has local anesthetic effect that is 15 times more potent than lidocaine the most widely used local anesthetic and probably explains its antiemetic action. It possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions as a 5-HT3 receptor antagonist, a Na channel blocker, and a mu-opioid agonist which may have a potential role in decreasing pain. The study aimed to demonstrate the effectiveness of IP administration of ondansetron on pain management post LC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who are scheduled to undergo elective LC

Exclusion Criteria:

• Patients undergoing chronic pain treatment

• Previous allergic response to local anesthetics or 5-HT3 receptor antagonists

• Patients who received analgesics or sedatives 24 h before scheduled surgery

Related Conditions & MeSH terms

• Cholecystitis

Intervention

Drug:
• Ondansetron
Interperitoneal administration in the gall bladder bed
• Normal saline
Interperitoneal administration in the gall bladder bed

Locations

Country	Name	City	State
Egypt	The National Hepatology and Tropical Research medicine institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Hepatology & Tropical Medicine Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in postoperative pain between the two groups using visual analogue score (VAS)		24 hours