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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00175591
Enrollment
25
Registered
2005-09-15
Start date
2007-08-31
Completion date
2011-06-30
Last updated
2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

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

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.

Interventions

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recordeduntil patient discharge

Secondary

MeasureTime frame
Pain ratingimmediately post-op
Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rateevery 8 hours
Time to dischargefrom end of surgery
Time (hours) from end of surgery to sitting on bed with legs hanging over the side

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026