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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175591
• Other study ID #: H05-70077
• Secondary ID: W05-0025
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: January 8, 2018
• Start date: August 2007
• Est. completion date: June 2011

Study information

• Verified date: January 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Administration of a femoral nerve block (bupivacaine HCL)
No details specified

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital, Department of Orthopaedics	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded		until patient discharge
Secondary	Pain rating		immediately post-op
Secondary	Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate		every 8 hours
Secondary	Time to discharge		from end of surgery
Secondary	Time (hours) from end of surgery to sitting on bed with legs hanging over the side