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Femoral Nerve Block for Femur Fracture Repair in Pediatrics

Primary Purpose

Traumatic Femur Fracture

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ropivicaine

Epinephrine

About this trial

This is an interventional treatment trial for Traumatic Femur Fracture

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nationwide Children's

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Femoral Nerve Block

Standard Anesthetic Management

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intraoperative End-tidal Isoflurane %

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

Time to First Opioid Dose

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

Full Information

NCT ID

NCT01759407

First Posted

December 29, 2012

Last Updated

January 2, 2018

Sponsor

Nationwide Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01759407

Brief Title

Femoral Nerve Block for Femur Fracture Repair in Pediatrics

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 Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Terminated

Why Stopped

Interim analysis showed no significant difference between study arms.

Study Start Date

May 2013 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Femur Fracture

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Femoral Nerve Block

Arm Type

Active Comparator

Arm Description

Arm Title

Standard Anesthetic Management

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Ropivicaine

Other Intervention Name(s)

Naropin

Intervention Type

Drug

Intervention Name(s)

Epinephrine

Primary Outcome Measure Information:

Title

Post-anesthesia Care Unit (PACU) Pain Scores

Description

Time Frame

30 mins after surgery

Secondary Outcome Measure Information:

Title

Intraoperative End-tidal Isoflurane %

Description

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

Time Frame

1 1/2 hr.

Title

Time to First Opioid Dose

Description

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicole Elsey, MD

Organizational Affiliation

Nationwide Children's

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nationwide Children's

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Femoral Nerve Block for Femur Fracture Repair in Pediatrics

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