NCT00175630

Brief Summary

This study evaluates the effect of a femoral nerve block on opioid requirements following anterior cruciate ligament (ACL) reconstruction. This is a double blind, prospective randomized controlled trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
5.2 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

September 13, 2005

Last Update Submit

May 30, 2016

Conditions

Pain, Postoperative

Keywords

ACL reconstructionmorphine sparingpreemptive analgesiaPost-operative pain and post- operative opioid use

Outcome Measures

Primary Outcomes (1)

  • Postoperative morphine requirement

Secondary Outcomes (2)

  • Pain rating

    immediately post-op

  • Opioid surgical time

    time from end of anaesthesia to first requirement of morphine

Interventions

Administration of a femoral nerve block (bupivacaine HCL)PROCEDURE

See Detailed Description

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Schedule for primary elective anterior cruciate ligament reconstruction
  • Tolerance to bupivacaine
  • Tolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
  • Informed consent

You may not qualify if:

  • Patients who received a femoral nerve block more than 1 hour prior to surgery
  • Complex associated injuries or pre-existing conditions that will delay time to ambulation
  • Children with tibial avulsion fractures
  • Allergic and/or sensitive to bupivacaine and/or NSAIDs
  • % over ideal body weight
  • Acute ACL reconstruction (done less than 2 weeks after injury)
  • Pre-existing femoral nerve injury
  • Psychiatric patients on psychotropic agents
  • History of drug or alcohol dependence or recreational drug use
  • Refusal to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Children's Hospital, Department of Orthopaedics

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Christopher Reilly, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

December 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

CA(1)