Femoral Nerve Block for Femur Fracture Repair in Pediatrics

Phase 2TerminatedNCT01759407

Nationwide Children's Hospital19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Traumatic Femur Fracture

Interventions

RopivicaineDRUG

EpinephrineDRUG

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nationwide Children's

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 mins after surgery

Secondary Outcomes

Intraoperative End-tidal Isoflurane %

Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery.

Time frame: 1 1/2 hr.

Time to First Opioid Dose

Median time between PACU discharge and first opioid dose on the ward.

Time frame: From PACU discharge until first opioid dose on the ward, assessed up to 24 hours

Data from ClinicalTrials.gov

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