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Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction (FNB for ACLR)

Primary Purpose

Analgesia After ACL Reconstruction

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
0.25% Bupivacaine
0.5% Bupivacaine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia After ACL Reconstruction focused on measuring femoral nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

0.25% bupivacaine

0.5% bupivacaine

Arm Description

femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine

femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine

Outcomes

Primary Outcome Measures

time to first analgesic requirement

Secondary Outcome Measures

pain score scale

Full Information

First Posted
May 4, 2012
Last Updated
April 8, 2015
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01593566
Brief Title
Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction
Acronym
FNB for ACLR
Official Title
Femoral Nerve Block Using 0.25% Versus 0.5% Bupivacaine for Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia After ACL Reconstruction
Keywords
femoral nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.25% bupivacaine
Arm Type
Active Comparator
Arm Description
femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine
Arm Title
0.5% bupivacaine
Arm Type
Active Comparator
Arm Description
femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine
Intervention Type
Drug
Intervention Name(s)
0.25% Bupivacaine
Other Intervention Name(s)
marcaine
Intervention Description
Femoral nerve block using 0.25% versus 0.5% bupivacaine
Intervention Type
Drug
Intervention Name(s)
0.5% Bupivacaine
Other Intervention Name(s)
marcaine
Intervention Description
Femoral nerve block using 0.25% versus 0.5% bupivacaine for analgesia after ACL reconstruction
Primary Outcome Measure Information:
Title
time to first analgesic requirement
Time Frame
48 hr
Secondary Outcome Measure Information:
Title
pain score scale
Time Frame
48 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
arissara iamaroon
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction

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