Oxycodone vs. Fentanyl in Early Postoperative Pain After... | NCT03019562

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

NCT03019562

Sponsor

Kyunghee University Medical Center

Status

Unknown status

Last Update Posted

Jan 12, 2017Estimated

Enrollment

46Estimated

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Oxycodone
Fentanyl

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jan 11, 2017

First Submission Date that Met QC Criteria

Jan 11, 2017

First Posted Date

Jan 12, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mi Kyeong Kim, Associate Professor, Kyunghee University Medical CenterPrincipal Investigator

Lead Sponsor

Kyunghee University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxycodone	Experimental	4mg of oxycodone iv bolus	Drug: Oxycodone
Fentanyl	Active Comparator	50ug of fentanyl iv bolus	Drug: Fentanyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone	Drug	4mg of oxycodone iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA)	Oxycodone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Mi Kyeong Kim, MD, PhD	Kyunghee University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyung Hee University Hospital	Recruiting	Seoul		02447	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010098	Oxycodone
D005283	Fentanyl

Ancestor Terms

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided