Analgesic Effect of Perineural Fentanyl Additive to Local... | NCT02331576

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

NCT02331576

Sponsor

Chonnam National University Hospital

Status

Unknown status

Last Update Posted

Jul 27, 2016Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

rocaine
Fentanyl

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Dec 23, 2014

First Submission Date that Met QC Criteria

Jan 4, 2015

First Posted Date

Jan 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2016

Last Update Posted Date

Jul 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

BHeo, assistant professor, Chonnam National University HospitalPrincipal Investigator

Lead Sponsor

Chonnam National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rocaine	Placebo Comparator	continuous femoral nerve block with ropivacaine alone.	Drug: rocaine
rocaine with fentanyl	Active Comparator	continuous femoral nerve block with combination of ropivacaine and fentanyl.	Drug: rocaine Drug: Fentanyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rocaine	Drug		rocaine rocaine with fentanyl	ropivacaine HCL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Visual Analogue Scales by time sequence		baseline(just after operation), 15, 30, 60 minute and 24 hour after intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bongha Heo, Dr.	Contact	082-010-9432-7126		bongha99@naver.com

Overall Officials

Name	Affiliation	Role
Bongha Heo, Dr	assistant professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonnam National University Hwasun Hospital	Recruiting	Hwasun	Jeollanam-do	519-763	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine
D005283	Fentanyl

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided