Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Completed
• Conditions: Cholecystitis
• Intervention / Treatment: Drug: Ondansetron; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • The National Hepatology and Tropical Research medicine institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in postoperative pain between the two groups using visual analogue score (VAS)	24 hours

Collaborators and Investigators

• Sponsor: National Hepatology & Tropical Medicine Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2020
• Primary Completion (ACTUAL): December 18, 2020
• Study Completion (ACTUAL): December 18, 2020

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (ACTUAL): July 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: 12-2020 (Other Identifier: Ifakara Health Institute Review Board (Tanzania))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No