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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00175591
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2007
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: Administration of a femoral nerve block (bupivacaine HCL)
    No details specified

Outcome Measures

Primary Outcome Measures :
  1. Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded [ Time Frame: until patient discharge ]

Secondary Outcome Measures :
  1. Pain rating [ Time Frame: immediately post-op ]
  2. Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate [ Time Frame: every 8 hours ]
  3. Time to discharge [ Time Frame: from end of surgery ]
  4. Time (hours) from end of surgery to sitting on bed with legs hanging over the side

Eligibility Criteria

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kishore Mulpuri, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175591     History of Changes
Other Study ID Numbers: H05-70077
W05-0025
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Analgesics, Opioid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotics
Analgesics