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

NCT ID: NCT03019562

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxycodone

4mg of oxycodone iv bolus

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

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

Fentanyl

50ug of fentanyl iv bolus

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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

Interventions

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Oxycodone

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

Intervention Type DRUG

Fentanyl

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

Intervention Type DRUG

Other Intervention Names

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Oxynorm

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Mi Kyeong Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mi Kyeong Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University Medical Center

Locations

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Kyung Hee University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Youngsoon Kim, MD, PhD

Role: CONTACT

+82-2-958-8598

Hee Yong Kang, MD

Role: CONTACT

+82-2-958-8589

Facility Contacts

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Youngsoon Kim

Role: primary

Other Identifiers

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KHUH 2016-09-047

Identifier Type: -

Identifier Source: org_study_id

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