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

April 8, 2015 updated by: arissara iamaroon, Mahidol University

Femoral Nerve Block Using 0.25% Versus 0.5% Bupivacaine for Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 0.25% bupivacaine
femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine
Drug: 0.25% Bupivacaine
Femoral nerve block using 0.25% versus 0.5% bupivacaine
Other Names:
  • marcaine
Active Comparator: 0.5% bupivacaine
femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine
Drug: 0.5% Bupivacaine
Femoral nerve block using 0.25% versus 0.5% bupivacaine for analgesia after ACL reconstruction
Other Names:
  • marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to first analgesic requirement
Time Frame: 48 hr
48 hr

Secondary Outcome Measures

Outcome Measure
Time Frame
pain score scale
Time Frame: 48 hr
48 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: arissara iamaroon, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mahidol University

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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