Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

Sponsor

National Hepatology & Tropical Medicine Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04468685

Collaborator

(none)

Enrollment

Location

Arms

5.1

Actual Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cholecystitis	Drug: Ondansetron Drug: Normal saline	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy

Actual Study Start Date :

Jul 15, 2020

Actual Primary Completion Date :

Dec 18, 2020

Actual Study Completion Date :

Dec 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ondansetron Ondansetron intraperitoneal in the gall bladder bed	Drug: Ondansetron Interperitoneal administration in the gall bladder bed
Placebo Comparator: Saline Normal saline intraperitoneal in the gall bladder bed	Drug: Normal saline Interperitoneal administration in the gall bladder bed

Arm

Intervention/Treatment

Experimental: Ondansetron

Ondansetron intraperitoneal in the gall bladder bed

Drug: Ondansetron

Interperitoneal administration in the gall bladder bed

Placebo Comparator: Saline

Normal saline intraperitoneal in the gall bladder bed

Drug: Normal saline

Interperitoneal administration in the gall bladder bed

Outcome Measures

Primary Outcome Measures

change in postoperative pain between the two groups using visual analogue score (VAS) [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The National Hepatology and Tropical Research medicine institute	Cairo		Egypt

Sponsors and Collaborators

National Hepatology & Tropical Medicine Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Doaa abdelaziz, Lecturer of clinical pharmacy, National Hepatology & Tropical Medicine Research Institute

ClinicalTrials.gov Identifier:

NCT04468685

Other Study ID Numbers:

12-2020

First Posted:

Jul 13, 2020

Last Update Posted:

Jan 12, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cholecystitis

Ondansetron

Study Results

No Results Posted as of Jan 12, 2021