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

Sponsor

Kyunghee University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03019562

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Oxycodone Drug: Fentanyl	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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),

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),

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Adverse effect [From immediately after surgery to 2 days after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyung Hee University Hospital	Seoul		Korea, Republic of	02447

Sponsors and Collaborators

Kyunghee University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mi Kyeong Kim, Associate Professor, Kyunghee University Medical Center

ClinicalTrials.gov Identifier:

NCT03019562

Other Study ID Numbers:

KHUH 2016-09-047

First Posted:

Jan 12, 2017

Last Update Posted:

Jan 12, 2017

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Mi Kyeong Kim, Associate Professor, Kyunghee University Medical Center

postoperative pain

Additional relevant MeSH terms:

Pain, Postoperative

Fentanyl

Oxycodone

Study Results

No Results Posted as of Jan 12, 2017