NCT02331576

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

December 23, 2014

Last Update Submit

July 25, 2016

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Visual Analogue Scales by time sequence

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

Study Arms (2)

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: rocaineDrug: Fentanyl

Interventions

rocaineDRUG
Also known as: ropivacaine HCL
rocainerocaine with fentanyl
FentanylDRUG
Also known as: fentanyl citrate
rocaine with fentanyl

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who scheduled to receive knee arthroplasty with general anesthesia
  • ASA physical status 1 or 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 519-763, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineFentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bongha Heo, Dr

    assistant professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bongha Heo, Dr.

CONTACT

082-010-9432-7126bongha99@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 23, 2014

First Posted

January 6, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

KR(1)