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

Phase 4

• Conditions: Pain, Postoperative
• Interventions: Drug: Oxycodone; Drug: Fentanyl

• Registration Number: NCT03019562
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Last Update Submitted: 2017-01-11
• Study First Posted: 2017-01-12
• Last Update Posted: 2017-01-12
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone	Oxycodone	4mg of oxycodone iv bolus
Fentanyl	Fentanyl	50ug of fentanyl iv bolus

Primary Outcome Measures

Name	Time	Method
Postoperative pain measurement using Numeric Rating Scale(NRS)	Immediately after surgery	Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU)

Secondary Outcome Measures

Name	Time	Method
Additional doses of fentanyl for pain management	From immediately after surgery to 2 days after surgery	0-6 hours, 6-12 hours, 12-24 hours, 24-48 hours after surgery

Trial Locations

Locations (1)

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of