search
Back to results

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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
rocaine
Fentanyl
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hwasun HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

rocaine

rocaine with fentanyl

Arm Description

continuous femoral nerve block with ropivacaine alone.

continuous femoral nerve block with combination of ropivacaine and fentanyl.

Outcomes

Primary Outcome Measures

Change from baseline in Visual Analogue Scales by time sequence

Secondary Outcome Measures

Full Information

First Posted
December 23, 2014
Last Updated
July 25, 2016
Sponsor
Chonnam National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02331576
Brief Title
Analgesic Effect of Perineural Fentanyl Additive to Local Anesthetics in Femoral Nerve Block
Official Title
Femoral Nerve Block in Patient With Total Knee Arthroplasty; Analgesic Effect of Perineural Fentanyl Additive to Local Anesthetics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rocaine
Arm Type
Placebo Comparator
Arm Description
continuous femoral nerve block with ropivacaine alone.
Arm Title
rocaine with fentanyl
Arm Type
Active Comparator
Arm Description
continuous femoral nerve block with combination of ropivacaine and fentanyl.
Intervention Type
Drug
Intervention Name(s)
rocaine
Other Intervention Name(s)
ropivacaine HCL
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
fentanyl citrate
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bongha Heo, Dr.
Phone
082-010-9432-7126
Email
bongha99@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bongha Heo, Dr
Organizational Affiliation
assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
ZIP/Postal Code
519-763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bongha Heo, Dr
Phone
082-010-9432-7126
Email
bongha99@naver.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs