Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

NCT04468685 | Completed Phase 2

• 1 other identifier: 12-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis

Outcome Measures

Primary Outcomes (1)

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

  24 hours

Study Arms (2)

Ondansetron

EXPERIMENTAL

Ondansetron intraperitoneal in the gall bladder bed

Drug: Ondansetron

Saline

PLACEBO COMPARATOR

Normal saline intraperitoneal in the gall bladder bed

Drug: Normal saline

Interventions

Ondansetron DRUG

Interperitoneal administration in the gall bladder bed

Ondansetron

Normal saline DRUG

Interperitoneal administration in the gall bladder bed

Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are scheduled to undergo elective LC

You may not qualify if:

• 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

Sponsors & Collaborators

• National Hepatology & Tropical Medicine Research Institute: lead

Study Sites (1)

The National Hepatology and Tropical Research medicine institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Cholecystitis

Interventions

Ondansetron; Saline Solution

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of clinical pharmacy

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: July 15, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)