Femoral Nerve Block for Femur Fracture Repair in Pediatrics

Phase 2

Terminated

• Conditions: Traumatic Femur Fracture
• Interventions: Drug: Ropivicaine; Drug: Epinephrine

• Registration Number: NCT01759407
• Lead Sponsor: Nationwide Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-29
• Study First Submitted QC: 2012-12-29
• Study First Posted: 2013-01-03
• Study Start: 2013-05
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-11-13
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-02
• Last Update Submitted: 2018-01-02
• Results First Posted: 2018-01-25
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral Nerve Block	Ropivicaine	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
Femoral Nerve Block	Epinephrine	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

Primary Outcome Measures

Name	Time	Method
Post-anesthesia Care Unit (PACU) Pain Scores	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 Outcome Measures

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

Trial Locations

Locations (1)

Nationwide Children's; 🇺🇸 Columbus, Ohio, United States