Femoral Nerve Block for Femur Fracture Repair in Pediatrics

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Double-blinded, Randomized Comparison of Ultrasound-guided Femoral Nerve Block With Lateral Femoral Cutaneous Nerve Block Versus Standard Anesthetic Management for Traumatic Femur Fracture Repair in the Pediatric Population

Conditions
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Traumatic Femur Fracture

Intervention / Treatment
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* Drug: Ropivicaine
* Drug: Epinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Femoral Nerve Block<br>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 | Drug: Ropivicaine<br> <br> * Other names: Naropin;Drug: Epinephrine<br> <br> |
| No Intervention: Standard Anesthetic Management<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-anesthesia Care Unit (PACU) Pain Scores | Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain. | 30 mins after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative End-tidal Isoflurane % | Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery. | 1 1/2 hr. | 
| Time to First Opioid Dose | Median time between PACU discharge and first opioid dose on the ward. | From PACU discharge until first opioid dose on the ward, assessed up to 24 hours |