Femoral Nerve Block for Femur Fracture Repair in Pediatrics

Nationwide Children's Hospital

Status and phase: Terminated; Phase 2

Conditions: Traumatic Femur Fracture

Treatments: Drug: Ropivicaine; Drug: Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT01759407

IRB16-00338

Details and patient eligibility

About

The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.

Enrollment: 19 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) physical status I or II
• Weight greater than or equal to 10kg
• Presenting for repair of traumatic femur fracture

Exclusion criteria

• ASA physical status > II
• Co-morbid diseases (cardiac, pulmonary, neurological disease)
• Patients having concomitant procedures
• Abnormal neurovascular examination in the injured leg
• Presence of vascular compromise in the affected lower extremity
• Mechanism of sustained injury via crush injury
• Use of therapeutic dose anticoagulants or presence of a bleeding disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 2 patient groups

Femoral Nerve Block

Active Comparator group

Description:

Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg

Treatment:

Drug: Ropivicaine

Drug: Epinephrine

Standard Anesthetic Management

No Intervention group