Femoral Nerve Block for Femur Fracture Repair in Pediatrics

NCT01759407 | Terminated Phase 2 Results

• 1 other identifier: IRB16-00338
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Femur Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Femoral Nerve Block

ACTIVE COMPARATOR

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

Drug: Ropivicaine; Drug: Epinephrine

Standard Anesthetic Management

NO INTERVENTION

Interventions

Ropivicaine DRUG

Also known as: Naropin

Femoral Nerve Block

Epinephrine DRUG

Femoral Nerve Block

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I or II
• Weight greater than or equal to 10kg
• Presenting for repair of traumatic femur fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Ropivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Nicole Elsey, MD
• Organization: Nationwide Children's Hospital

Nicole.Elsey@nationwidechildrens.org

614-722-4200

Study Officials

• Nicole Elsey, MD

  Nationwide Children's

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 29, 2012
• First Posted: January 3, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 25, 2018
• Results First Posted: January 25, 2018

Record last verified: 2018-01

Locations

US (1)