Back to resultsThe Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Administration of a femoral nerve block (bupivacaine HCL)
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Femur fracture, morphine sparing, preemptive analgesia, Post-operative pain and post- operative opioid use
Eligibility 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
Sites / Locations
- British Columbia Children's Hospital, Department of Orthopaedics
Outcomes
Primary Outcome Measures
Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded
Secondary Outcome Measures
Pain rating
Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate
Time to discharge
Time (hours) from end of surgery to sitting on bed with legs hanging over the side
Full Information
NCT ID
NCT00175591
First Posted
September 13, 2005
Last Updated
January 8, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00175591
Brief Title
The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children
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 Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Femur fracture, morphine sparing, preemptive analgesia, Post-operative pain and post- operative opioid use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Administration of a femoral nerve block (bupivacaine HCL)
Intervention Description
No details specified
Primary Outcome Measure Information:
Title
Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded
Time Frame
until patient discharge
Secondary Outcome Measure Information:
Title
Pain rating
Time Frame
immediately post-op
Title
Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate
Time Frame
every 8 hours
Title
Time to discharge
Time Frame
from end of surgery
Title
Time (hours) from end of surgery to sitting on bed with legs hanging over the side
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kishore Mulpuri, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Children's Hospital, Department of Orthopaedics
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
12. IPD Sharing Statement
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The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children
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