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

January 11, 2017 updated by: Mi Kyeong Kim, Kyunghee University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain measurement using Numeric Rating Scale(NRS)
Time Frame: Immediately after surgery
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
Time Frame: From immediately after surgery to 2 days after surgery
0-6 hours, 6-12 hours, 12-24 hours, 24-48 hours after surgery
From immediately after surgery to 2 days after surgery

Other Outcome Measures

Outcome Measure
Time Frame
Adverse effect
Time Frame: From immediately after surgery to 2 days after surgery
From immediately after surgery to 2 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: Mi Kyeong Kim, MD, PhD, Kyunghee University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHUH 2016-09-047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on Oxycodone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe