Oxycodone vs. Fentanyl in Early Postoperative Pain After Total Hip Replacement

Study Overview
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Brief Summary
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Oxycodone is one of the most widely used opioids for pain treatment. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients after total hip replacement surgery.

Detailed Description
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Oxycodone is one of the most widely used opioids for pain treatment. There have been several studies on the efficacy and side effects of oxycodone. Oxycodone has been known to have the same potency with morphine. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we designed a prospective, randomized, and double-blind study to assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients who underwent the total hip replacement surgery.

Official Title
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Oxycodone vs. Fentanyl in the Treatment of Early Postoperative Pain After Total Hip Replacement

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19-65 years of age ASA physical status classification I or II Scheduled for total hip replacement surgery Exclusion Criteria: Allergic to study drugs Patient with asthma or COPD, patient who is severely respiratory depressed Renal of hepatic insufficiency Epileptic status Intracranial lesion associated with increased intracranial pressure Acute abdomen, patient who has diagnosed paralytic ileus or suspicious ileus Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone<br>4mg of oxycodone iv bolus | Drug: Oxycodone<br>* 4mg of oxycodone iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA)<br>* Other names: Oxynorm;|
| Active Comparator: Fentanyl<br>50ug of fentanyl iv bolus | Drug: Fentanyl<br>* 50ug of fentanyl iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA),<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain measurement using Numeric Rating Scale(NRS) | Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU) | Immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional doses of fentanyl for pain management | 0-6 hours, 6-12 hours, 12-24 hours, 24-48 hours after surgery | From immediately after surgery to 2 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain