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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05602519
Other study ID # IRB 00012367-22-010-005
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 10, 2022
Est. completion date May 30, 2023

Study information

Verified date August 2023
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Oxycodone showed similar or superior analgesic effects than fentanyl and was proposed as an alternative for fentanyl for pain control in the postoperative period. However, it was mainly directed to control visceral pain, due to the mediation of analgesic effects by the kappa receptors. However, few studies compared the oxycodone to fentanyl for postoperative pain relief in patients undergoing total hip arthroplasty (replacement). Therefore, we established this randomized study to compare the efficacy of oxycodone and fentanyl for relief of postoperative pain after total hip arthroplasty (replacement).


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date May 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers No
Gender All
Age group 28 Years to 62 Years
Eligibility Inclusion Criteria: - Patients aged 28-62 years old, - Both genders, American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for elective total hip surgery. Exclusion Criteria: - Patients with history of any kind of drug allergy. - drug abuse. - psychological or other emotional problems, - renal and hepatic chronic disease.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
propofol, rocuronium and fentanyl
In fentanyl group (36 patients), 50 ug of fentanyl, and in oxycodone group, 4 mg of oxycodone will be administered 20 minutes before the end of the surgery, in triple blind manner.

Locations

Country Name City State
Egypt Facualty of Medicine (Damietta), Al Azhar University Damieta

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improving A post-anesthesia care unit (PACU) pain score. The visual analogue scale (VAS) will be used for assessment of postoperative pain severity (0 for no pain and 10 for the most severe pain). 48 hours
Secondary Hemodynamics Mean arterial blood pressure and heart rate will be recorded at baseline and every 5 min till the end of procedure. 48 hours
Secondary Postoperative side effects Any side effects will be documented. Postoperative nausea and vomiting (if occurred) will be treated by intravenous administration of metoclopramide (10mg). 48 hours
Secondary Postoperative consumption of opioid The overall dose of fentanyl administrated in the first 48 postoperative hours will be documented at 6, 12, 24 and 48 hours. 48 hours postoperatively
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