Femoral Nerve Block for Femur Fracture Repair in Pediatrics

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy Study of Femoral Nerve Block in Children With a Femur Fracture

NCT01294098

Femoral Fractures Pain, Postoperative

TERMINATED NA

Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture

NCT05947292

Femur Fracture

COMPLETED

The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children

NCT00175591

Pain, Postoperative

COMPLETED PHASE1

Ultrasound Guided Adductor Canal Versus Femoral Nerve Blocks for Anterior Cruciate Ligament Reconstruction in Pediatrics

NCT03053401

Post-operative Pain Quadriceps Muscle Strength

COMPLETED NA

Pain Management in Children Undergoing Supracondylar Humerus Fracture Repair

NCT01812863

Humeral Fractures Fractures, Closed

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Femur Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Ropivicaine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Standard Anesthetic Management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ropivicaine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Naropin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No