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

Study Overview
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Brief Summary
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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).

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

Conditions
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Total Hip Arthroplasty, The Analgesic Efficacy

Intervention / Treatment
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* Drug: propofol, rocuronium and fentanyl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group fentanyl<br>Patients will receive 50 ug of fentanyl 20 min before the end of surgery. | Drug: propofol, rocuronium and fentanyl<br>* 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.<br>|
| Active Comparator: Group oxycodone<br>Patients will receive 4 mg of oxycodone 20 min before the end of surgery. | Drug: propofol, rocuronium and fentanyl<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamics | Mean arterial blood pressure and heart rate will be recorded at baseline and every 5 min till the end of procedure. | 48 hours | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxycodone Hydrochloride, Fentanyl