Traumatic Femur Fracture Clinical Trial
Official title:
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
| Verified date | January 2018 |
| Source | Nationwide Children's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 19 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Nationwide Children's | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Nationwide Children's Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Intraoperative End-tidal Isoflurane % | Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery. | 1 1/2 hr. | |
| Secondary | 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 |