Analgesic Effect of Perineural Fentanyl Additive to Local Anesthetics in Femoral Nerve Block

Postoperative Pain Clinical Trial

Official title:

Femoral Nerve Block in Patient With Total Knee Arthroplasty; Analgesic Effect of Perineural Fentanyl Additive to Local Anesthetics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331576
• Other study ID #: CNUHH-2014-141
• Status: Recruiting
• Phase: N/A
• First received: December 23, 2014
• Last updated: July 25, 2016
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Chonnam National University Hospital
• Contact: Bongha Heo, Dr.
• Phone: 082-010-9432-7126
• Email: bongha99[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the analgesic efficacy of perineural fentanyl combined with local anesthetics in the post operative pain control with continuous femoral nerve block after total knee arthroplasty.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients who scheduled to receive knee arthroplasty with general anesthesia

• ASA physical status 1 or 2

Exclusion Criteria:

• allergy to drug

• refuse to the study

• ASA physical status 3 and 4

• history of drug abuse

• cognitive disfunction such as dementia

• patients who do not adequate for general anesthesia

Study Design

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• rocaine

• Fentanyl

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeollanam-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Visual Analogue Scales by time sequence		baseline(just after operation), 15, 30, 60 minute and 24 hour after intervention	No