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

Phase 4

Completed

• Conditions: Total Hip Arthroplasty; The Analgesic Efficacy
• Interventions: Drug: propofol, rocuronium and fentanyl

• Registration Number: NCT05602519
• Lead Sponsor: Al-Azhar University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-02
• Study Start: 2022-11-10
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group fentanyl	propofol, rocuronium and fentanyl	Patients will receive 50 ug of fentanyl 20 min before the end of surgery.
Group oxycodone	propofol, rocuronium and fentanyl	Patients will receive 4 mg of oxycodone 20 min before the end of surgery.

Primary Outcome Measures

Name	Time	Method
Improving A post-anesthesia care unit (PACU) pain score.	48 hours	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).

Secondary Outcome Measures

Name	Time	Method
Hemodynamics	48 hours	Mean arterial blood pressure and heart rate will be recorded at baseline and every 5 min till the end of procedure.
Postoperative side effects	48 hours	Any side effects will be documented. Postoperative nausea and vomiting (if occurred) will be treated by intravenous administration of metoclopramide (10mg).
Postoperative consumption of opioid	48 hours postoperatively	The overall dose of fentanyl administrated in the first 48 postoperative hours will be documented at 6, 12, 24 and 48 hours.

Trial Locations

Locations (1)

Facualty of Medicine (Damietta), Al Azhar University; 🇪🇬 Damieta, Egypt