Femoral Nerve Block for Femur Fracture Repair in Pediatrics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01759407|
Recruitment Status : Terminated (Interim analysis showed no significant difference between study arms.)
First Posted : January 3, 2013
Results First Posted : January 25, 2018
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Femur Fracture||Drug: Ropivicaine Drug: Epinephrine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Active Comparator: 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
Other Name: NaropinDrug: Epinephrine
|No Intervention: Standard Anesthetic Management|
- 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.
- Intraoperative End-tidal Isoflurane % [ Time Frame: 1 1/2 hr. ]Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery.
- Time to First Opioid Dose [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759407
|United States, Ohio|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Nicole Elsey, MD||Nationwide Children's|