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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:
ClinicalTrials.gov Identifier:
NCT00175591
First Posted: September 15, 2005
Last Update Posted: June 9, 2011
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.
Information provided by:
University of British Columbia
September 13, 2005
September 15, 2005
June 9, 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 ]
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 ]
  • Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate [ Time Frame: every 8 hours ]
  • Time to discharge [ Time Frame: from end of surgery ]
  • Time (hours) from end of surgery to sitting on bed with legs hanging over the side
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
5 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00175591
H05-70077
W05-0025
No
Not Provided
Not Provided
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