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

This study is currently recruiting participants.

Verified by University of British Columbia, September 2008

First Received: September 13, 2005 Last Updated: September 22, 2008 History of Changes

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175591

Purpose

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	Intervention	Phase
Pain, Postoperative	Procedure: Administration of a femoral nerve block (bupivacaine HCL)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Fractures Nausea and Vomiting Surgery

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

No details specified

Eligibility

Ages Eligible for Study:	5 Years to 12 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175591

Contacts

Contact: Bronwyn Tritt

604-875-2359

btritt@cw.bc.ca

Locations

Canada, British Columbia
British Columbia Children's Hospital, Department of Orthopaedics	Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Bronwyn Tritt 604-875-2359 btritt@cw.bc.ca
Principal Investigator: Kishore Mulpuri, MD

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Kishore Mulpuri, MD

University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia ( Dr. Kishore Mulpuri )
Study ID Numbers:	C05-0077, W05-0025
Study First Received:	September 13, 2005
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00175591 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Femur fracture
morphine sparing
preemptive analgesia
Post-operative pain and post- operative opioid use

Study placed in the following topic categories:

Morphine
Fractures, Bone
Anesthetics
Central Nervous System Depressants
Pain
Anesthetics, Local
Signs and Symptoms

Femoral Fractures
Postoperative Complications
Bupivacaine
Peripheral Nervous System Agents
Analgesics
Pain, Postoperative
Analgesics, Opioid

Additional relevant MeSH terms:

Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pain
Anesthetics, Local
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications

Sensory System Agents
Therapeutic Uses
Bupivacaine
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 02, 2009