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OpenTrials
Completed

NCT Number: NCT04468685

Ondansetron Effect 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The National Hepatology and Tropical Research medicine institute

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron

Drug

Interperitoneal administration in the gall bladder bed

normal saline

Drug

Interperitoneal administration in the gall bladder bed

Primary outcomes

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

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

National Hepatology & Tropical Medicine Research Institute

Other Gov

Registry information

Official study title

Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2020
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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