NCT01593566

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

May 4, 2012

Last Update Submit

April 8, 2015

Conditions

Analgesia After ACL Reconstruction

Keywords

femoral nerve block

Outcome Measures

Primary Outcomes (1)

  • time to first analgesic requirement

    48 hr

Secondary Outcomes (1)

  • pain score scale

    48 hr

Study Arms (2)

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

0.25% BupivacaineDRUG

Femoral nerve block using 0.25% versus 0.5% bupivacaine

Also known as: marcaine
0.25% bupivacaine
0.5% BupivacaineDRUG

Femoral nerve block using 0.25% versus 0.5% bupivacaine for analgesia after ACL reconstruction

Also known as: marcaine
0.5% bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • arissara iamaroon

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
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
associated professor

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 8, 2012

Study Start

April 1, 2011

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

TH(1)