The Analgesic Efficacy of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty:

Total Hip Arthroplasty Clinical Trial

Official title:

The Analgesic Efficacy and Safety of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty: A Randomized Triple-Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05602519
• Other study ID #: IRB 00012367-22-010-005
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Total Hip Arthroplasty

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