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

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ClinicalTrials.gov Identifier: NCT03019562
Recruitment Status : Unknown
Verified January 2017 by Mi Kyeong Kim, Kyunghee University Medical Center.
Recruitment status was:  Recruiting
First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Mi Kyeong Kim, Kyunghee University Medical Center

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

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 Name: 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),




Primary Outcome Measures :
  1. Postoperative pain measurement using Numeric Rating Scale(NRS) [ Time Frame: Immediately after surgery ]
    Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU)


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Adverse effect [ Time Frame: From immediately after surgery to 2 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019562


Contacts
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Contact: Youngsoon Kim, MD, PhD +82-2-958-8598 ys.kim@khu.ac.kr
Contact: Hee Yong Kang, MD +82-2-958-8589 ujuabba@gmail.com

Locations
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Korea, Republic of
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 02447
Contact: Youngsoon Kim    958-8589    ys.kim@khu.ac.kr   
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
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Principal Investigator: Mi Kyeong Kim, MD, PhD Kyunghee University Medical Center

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Responsible Party: Mi Kyeong Kim, Associate Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT03019562     History of Changes
Other Study ID Numbers: KHUH 2016-09-047
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mi Kyeong Kim, Kyunghee University Medical Center:
postoperative pain

Additional relevant MeSH terms:
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Oxycodone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics