NCT00175591

Brief Summary

This study evaluates the effect of a femoral nerve block on opioid requirements following femoral fracture fixation with flexible nails in the paediatric population. This is a double blind, prospective randomized clinical trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_1

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

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
1.9 years until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

September 13, 2005

Last Update Submit

January 8, 2018

Conditions

Pain, Postoperative

Keywords

Femur fracturemorphine sparingpreemptive analgesiaPost-operative pain and post- operative opioid use

Outcome Measures

Primary Outcomes (1)

  • Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded

    until patient discharge

Secondary Outcomes (4)

  • Pain rating

    immediately post-op

  • Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate

    every 8 hours

  • Time to discharge

    from end of surgery

  • Time (hours) from end of surgery to sitting on bed with legs hanging over the side

Interventions

Administration of a femoral nerve block (bupivacaine HCL)PROCEDURE

No details specified

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Femoral shaft fracture requiring intra-medullary nailing
  • Surgery performed within 24 hours of injury
  • Ability of child or family to use patient-controlled analgesia (PCA)
  • No allergy or sensitivity to bupivacaine
  • Informed consent and assent

You may not qualify if:

  • Open femur fractures
  • Closed fractures needing open reduction
  • Fractures associated with neurovascular complications
  • Fractures associated with compartment syndrome
  • Repeat femoral surgeries
  • Patients who received a femoral nerve block more than 1 hour prior to surgery
  • Complex associated injuries or pre-existing condition that will delay time to ambulation
  • Children who are allergic and/or sensitive to bupivacaine

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, PostoperativeFemoral Fractures

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Kishore Mulpuri, 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
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

August 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 10, 2018

Record last verified: 2018-01

Locations

CA(1)