Femoral Nerve Block for Analgesia After Anterior Cruciate... | NCT01593566

Studies
Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction

NCT01593566

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Apr 9, 2015Estimated

Enrollment

100Actual

Phase

Phase 4

Conditions

Analgesia After ACL Reconstruction

Interventions

0.25% Bupivacaine
0.5% Bupivacaine

Countries

Thailand

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Apr 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

May 4, 2012

First Submission Date that Met QC Criteria

May 7, 2012

First Posted Date

May 8, 2012Estimated

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

Apr 8, 2015

Last Update Posted Date

Apr 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Femoral nerve block using 0.25% bupivacaine or 0.5% bupivacaine provides a longer time for analgesia after Anterior Cruciate Ligament (ACL) reconstruction.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.25% bupivacaine	Active Comparator	femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine	Drug: 0.25% Bupivacaine
0.5% bupivacaine	Active Comparator	femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine	Drug: 0.5% Bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.25% Bupivacaine	Drug	Femoral nerve block using 0.25% versus 0.5% bupivacaine	0.25% bupivacaine

Measure	Description	Time Frame
time to first analgesic requirement		48 hr

Measure	Description	Time Frame
pain score scale		48 hr

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for ACL reconstruction
ASA physical status I-II
Body weight > or = 50 kg.

Exclusion Criteria:

Patients with redo ACL reconstruction
Contraindication to neuraxial block
allergy to local anesthetics, sulfa, NSAIDs, morphine, paracetamol
Patients with communication problem

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
arissara iamaroon	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hospital, Mahidol University		Bangkok		10700	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided