- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02331576
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
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 Contact
- Name: Bongha Heo, Dr.
- Phone Number: 082-010-9432-7126
- Email: bongha99@naver.com
Study Locations
-
-
Jeollanam-do
-
Hwasun, Jeollanam-do, Korea, Republic of, 519-763
- Recruiting
- Chonnam National University Hwasun Hospital
-
Contact:
- Bongha Heo, Dr
- Phone Number: 082-010-9432-7126
- Email: bongha99@naver.com
-
-
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.
|
Other Names:
|
Active Comparator: rocaine with fentanyl
continuous femoral nerve block with combination of ropivacaine and fentanyl.
|
Other Names:
Other Names:
|
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.
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
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Fentanyl
- Ropivacaine
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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