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

July 25, 2016 updated by: BHeo, Chonnam National University Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 519-763
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: rocaine
continuous femoral nerve block with ropivacaine alone.
Drug: rocaine
Other Names:
  • ropivacaine HCL
Active Comparator: rocaine with fentanyl
continuous femoral nerve block with combination of ropivacaine and fentanyl.
Drug: Fentanyl
Other Names:
  • fentanyl citrate
Drug: rocaine
Other Names:
  • ropivacaine HCL

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Investigators

  • Principal Investigator: Bongha Heo, Dr, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

January 4, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNUHH-2014-141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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