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Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

Primary Purpose

Cholecystitis

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Ondansetron

Normal saline

About this trial

This is an interventional treatment trial for Cholecystitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The National Hepatology and Tropical Research medicine institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ondansetron

Saline

Arm Description

Ondansetron intraperitoneal in the gall bladder bed

Normal saline intraperitoneal in the gall bladder bed

Outcomes

Primary Outcome Measures

change in postoperative pain between the two groups using visual analogue score (VAS)

Secondary Outcome Measures

Full Information

NCT ID

NCT04468685

First Posted

July 8, 2020

Last Updated

January 11, 2021

Sponsor

National Hepatology & Tropical Medicine Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04468685

Brief Title

Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

Official Title

Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

July 15, 2020 (Actual)

Primary Completion Date

December 18, 2020 (Actual)

Study Completion Date

December 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Hepatology & Tropical Medicine Research Institute

4. Oversight

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.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholecystitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ondansetron

Arm Type

Experimental

Arm Description

Ondansetron intraperitoneal in the gall bladder bed

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

Normal saline intraperitoneal in the gall bladder bed

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Intervention Description

Interperitoneal administration in the gall bladder bed

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

Interperitoneal administration in the gall bladder bed

Primary Outcome Measure Information:

Title

change in postoperative pain between the two groups using visual analogue score (VAS)

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

The National Hepatology and Tropical Research medicine institute

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

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Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

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