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

Primary Purpose

Pain, Postoperative

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Oxycodone

Fentanyl

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring postoperative pain

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Kyung Hee University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxycodone

Fentanyl

Arm Description

4mg of oxycodone iv bolus

50ug of fentanyl iv bolus

Outcomes

Primary Outcome Measures

Postoperative pain measurement using Numeric Rating Scale(NRS)

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

Secondary Outcome Measures

Additional doses of fentanyl for pain management

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

Full Information

NCT ID

NCT03019562

First Posted

January 11, 2017

Last Updated

January 11, 2017

Sponsor

Kyunghee University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03019562

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

Keywords

postoperative pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oxycodone

Arm Type

Experimental

Arm Description

4mg of oxycodone iv bolus

Arm Title

Fentanyl

Arm Type

Active Comparator

Arm Description

50ug of fentanyl iv bolus

Intervention Type

Drug

Intervention Name(s)

Oxycodone

Other Intervention Name(s)

Oxynorm

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Fentanyl

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative pain measurement using Numeric Rating Scale(NRS)

Description

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

Time Frame

Immediately after surgery

Secondary Outcome Measure Information:

Title

Additional doses of fentanyl for pain management

Description

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

Other Pre-specified Outcome Measures:

Title

Adverse effect

Time Frame

From immediately after surgery to 2 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Youngsoon Kim, MD, PhD

Phone

+82-2-958-8598

ys.kim@khu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Hee Yong Kang, MD

Phone

+82-2-958-8589

ujuabba@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mi Kyeong Kim, MD, PhD

Organizational Affiliation

Kyunghee University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyung Hee University Hospital

City

Seoul

ZIP/Postal Code

02447

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Youngsoon Kim

Phone

958-8589

ys.kim@khu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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