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Completed

NCT Number: NCT00175591

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

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.

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Key information

Conditions

Pain, Postoperative Femoral Fractures Fractures, Bone Leg Injuries Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

British Columbia Children's Hospital, Department of Orthopaedics

Vancouver, British Columbia, V6H 3V4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of a femoral nerve block (bupivacaine HCL)

Procedure

No details specified

Primary outcomes

  1. Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded

    Time frame: until patient discharge

Secondary outcomes

  1. Pain rating

    Time frame: immediately post-op

  2. Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate

    Time frame: every 8 hours

  3. Time to discharge

    Time frame: from end of surgery

  4. Time (hours) from end of surgery to sitting on bed with legs hanging over the side

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 15, 2005
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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