Brief Title
Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy
Official Title
Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
change in postoperative pain between the two groups using visual analogue score (VAS)
Condition
Cholecystitis
Intervention
Ondansetron
Study Arms / Comparison Groups
Ondansetron
Description: Ondansetron intraperitoneal in the gall bladder bed
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
50
Start Date
July 15, 2020
Completion Date
December 18, 2020
Primary Completion Date
December 18, 2020
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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Egypt
Location Countries
Egypt
Administrative Informations
NCT ID
NCT04468685
Organization ID
12-2020
Responsible Party
Principal Investigator
Study Sponsor
National Hepatology & Tropical Medicine Research Institute
Study Sponsor
, ,
Verification Date
January 2021