Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction

Analgesia After ACL Reconstruction Clinical Trial

— FNB for ACLR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593566
• Other study ID #: Mahidol University
• Status: Completed
• Phase: Phase 4
• First received: May 4, 2012
• Last updated: April 8, 2015
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: April 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia After ACL Reconstruction

Intervention

Drug:
• 0.25% Bupivacaine
Femoral nerve block using 0.25% versus 0.5% bupivacaine
• 0.5% Bupivacaine
Femoral nerve block using 0.25% versus 0.5% bupivacaine for analgesia after ACL reconstruction

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first analgesic requirement		48 hr	Yes
Secondary	pain score scale		48 hr	Yes