The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children

This study has been terminated.
(It has become a standard of care to give Femoral nerve blocks and have discontinued this study)
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175591
First received: September 13, 2005
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Procedure: Administration of a femoral nerve block (bupivacaine HCL)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Femoral Nerve Block on Opioid Requirements Following Femoral Fracture Fixation With Flexible Nails in the Paediatric Population: A Double Blind, Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded [ Time Frame: until patient discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain rating [ Time Frame: immediately post-op ] [ Designated as safety issue: No ]
  • Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate [ Time Frame: every 8 hours ] [ Designated as safety issue: No ]
  • Time to discharge [ Time Frame: from end of surgery ] [ Designated as safety issue: No ]
  • Time (hours) from end of surgery to sitting on bed with legs hanging over the side [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Administration of a femoral nerve block (bupivacaine HCL)
    No details specified
  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175591

Locations
Canada, British Columbia
British Columbia Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Kishore Mulpuri, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Kishore Mulpuri, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175591     History of Changes
Other Study ID Numbers: H05-70077, W05-0025
Study First Received: September 13, 2005
Last Updated: June 8, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Femur fracture
morphine sparing
preemptive analgesia
Post-operative pain and post- operative opioid use

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014