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
Overview
- Phase
- Phase 2
- Intervention
- Ropivicaine
- Conditions
- Traumatic Femur Fracture
- Sponsor
- Nationwide Children's Hospital
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Post-anesthesia Care Unit (PACU) Pain Scores
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Nicole Elsey
Clinical Assistant Professor
Nationwide Children's Hospital
Eligibility Criteria
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
Arms & Interventions
Femoral Nerve Block
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
Intervention: Ropivicaine
Femoral Nerve Block
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
Intervention: Epinephrine
Outcomes
Primary Outcomes
Post-anesthesia Care Unit (PACU) Pain Scores
Time Frame: 30 mins after surgery
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.
Secondary Outcomes
- Intraoperative End-tidal Isoflurane %(1 1/2 hr.)
- Time to First Opioid Dose(From PACU discharge until first opioid dose on the ward, assessed up to 24 hours)