Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2020-12-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ondansetron

Ondansetron intraperitoneal in the gall bladder bed

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

Interperitoneal administration in the gall bladder bed

Saline

Normal saline intraperitoneal in the gall bladder bed

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Interperitoneal administration in the gall bladder bed

Interventions

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Ondansetron

Interperitoneal administration in the gall bladder bed

Intervention Type DRUG

Normal saline

Interperitoneal administration in the gall bladder bed

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No