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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03019562
• Other study ID #: KHUH 2016-09-047
• Status: Recruiting
• Phase: Phase 4
• First received: January 11, 2017
• Last updated: January 11, 2017
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Kyunghee University Medical Center
• Contact: Youngsoon Kim, MD, PhD
• Phone: +82-2-958-8598
• Email: ys.kim[@]khu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Oxycodone
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 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA),

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effect		From immediately after surgery to 2 days after surgery	No
Primary	Postoperative pain measurement using Numeric Rating Scale(NRS)	Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU)	Immediately after surgery	No
Secondary	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	No