- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00175591
The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children
January 8, 2018 updated by: Kishore Mulpuri, University of British Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital, Department of Orthopaedics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded
Time Frame: until patient discharge
|
until patient discharge
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain rating
Time Frame: immediately post-op
|
immediately post-op
|
Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate
Time Frame: every 8 hours
|
every 8 hours
|
Time to discharge
Time Frame: from end of surgery
|
from end of surgery
|
Time (hours) from end of surgery to sitting on bed with legs hanging over the side
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kishore Mulpuri, MD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
January 10, 2018
Last Update Submitted That Met QC Criteria
January 8, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H05-70077
- W05-0025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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