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

Phase 4UnknownNCT03019562

Kyunghee University Medical Center46 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain, Postoperative

Interventions

OxycodoneDRUG

4mg of oxycodone iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA)

FentanylDRUG

50ug of fentanyl iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA),

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Kyung Hee University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Postoperative pain measurement using Numeric Rating Scale(NRS)

Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU)

Time frame: Immediately after surgery

Secondary Outcomes

Additional doses of fentanyl for pain management

0-6 hours, 6-12 hours, 12-24 hours, 24-48 hours after surgery

Time frame: From immediately after surgery to 2 days after surgery

Central Contacts

Youngsoon Kim, MD, PhD

CONTACT

+82-2-958-8598 ys.kim@khu.ac.kr

Hee Yong Kang, MD

CONTACT

+82-2-958-8589 ujuabba@gmail.com

Data from ClinicalTrials.gov

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