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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
History of Changes

September 13, 2005
June 8, 2011
August 2007
June 2011   (final data collection date for primary outcome measure)
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 ]
Post-operative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded until patient discharge
Complete list of historical versions of study NCT00175591 on ClinicalTrials.gov Archive Site
  • 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 ]
Pain rating (immediately post-op); sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate (every 8 hours); time to discharge (from end of surgery); time from end of surgery to sitting on bed with legs hanging over the side (hours); range of
Not Provided
Not Provided
 
The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain, Postoperative
Procedure: Administration of a femoral nerve block (bupivacaine HCL)
No details specified
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
5 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00175591
H05-70077, W05-0025
No
Dr. Kishore Mulpuri, University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Kishore Mulpuri, MD University of British Columbia
University of British Columbia
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP