NCT02331576UnknownNot Applicable

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

Chonnam National University Hospital1 site in 1 country100 target enrollmentStarted: January 2015Last updated: July 27, 2016

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Not Applicable
Sponsor: Chonnam National University Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: Change from baseline in Visual Analogue Scales by time sequence

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 60 Years to 90 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

Arms & Interventions

rocaine

Placebo Comparator

continuous femoral nerve block with ropivacaine alone.

Intervention: rocaine (Drug)

rocaine with fentanyl

Active Comparator

continuous femoral nerve block with combination of ropivacaine and fentanyl.

Intervention: rocaine (Drug)

rocaine with fentanyl

Active Comparator

continuous femoral nerve block with combination of ropivacaine and fentanyl.

Intervention: Fentanyl (Drug)

Outcomes

Primary Outcomes

Change from baseline in Visual Analogue Scales by time sequence

Time Frame: baseline(just after operation), 15, 30, 60 minute and 24 hour after intervention

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Chonnam National University Hospital

Sponsor Class

Other

Responsible Party

Principal Investigator

BHeo

assistant professor

Chonnam National University Hospital

Study Sites (1)

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