Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy
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StatusRekrytering
Sponsorer
National Hepatology & Tropical Medicine Research Institute
KLINISK PRÖVNING: NCT04468685
BioSeek: nct04468685
Nyckelord
Abstrakt
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.
Datum
| Senast verifierad: | 06/30/2020 |
| Först skickat: | 07/07/2020 |
| Beräknad anmälan inlämnad: | 07/09/2020 |
| Först publicerad: | 07/12/2020 |
| Senaste uppdatering skickad: | 07/18/2020 |
| Senaste uppdatering publicerad: | 07/20/2020 |
| Faktiskt startdatum för studien: | 07/14/2020 |
| Uppskattat primärt slutdatum: | 08/31/2020 |
| Beräknat slutfört datum: | 08/31/2020 |
Tillstånd eller sjukdom
Cholecystitis
Intervention / behandling
Drug: Ondansetron
Drug: Saline
Fas
Fas 2
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| 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: Saline Interperitoneal administration in the gall bladder bed |
Urvalskriterier
| Åldrar berättigade till studier | 18 Years Till 18 Years |
| Kön som är berättigade till studier | All |
| Accepterar friska volontärer | Ja |
| Kriterier | 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 |
Resultat
Primära resultatåtgärder
1. change in postoperative pain between the two groups using visual analogue score (VAS) [24 hours]
