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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-06-30

Brief Summary

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

This study evaluates the effect of a femoral nerve block on opioid requirements following femoral fracture fixation with flexible nails in the paediatric population. This is a double blind, prospective randomized clinical trial.

Related Clinical Trials

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

Femoral Nerve Block for Femur Fracture Repair in Pediatrics

NCT01759407

Traumatic Femur Fracture

TERMINATED PHASE2

The Effect of Femoral Nerve Block on Postoperative Opioid Use After Anterior Cruciate Ligament (ACL) Reconstruction

NCT00175630

Pain, Postoperative

UNKNOWN PHASE1

Comparison of Femoral Nerve Block Versus Fascia Iliaca Compartment Block for Pain Control in Traumatic Femur Fracture Repair in Pediatric Population

NCT05882201

Regional Anesthesia Morbidity

UNKNOWN NA

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

NCT01294098

Femoral Fractures Pain, Postoperative

TERMINATED NA

Regional Blocks for Lateral Condyle Fractures

NCT03796572

Fractures, Closed Humeral Fractures Pain

RECRUITING PHASE4

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.

Pain, Postoperative

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

DOUBLE

Participants Investigators

Interventions

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

Administration of a femoral nerve block (bupivacaine HCL)

No details specified

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Femoral shaft fracture requiring intra-medullary nailing
* Surgery performed within 24 hours of injury
* Ability of child or family to use patient-controlled analgesia (PCA)
* No allergy or sensitivity to bupivacaine
* Informed consent and assent

Exclusion Criteria

* Open femur fractures
* Closed fractures needing open reduction
* Fractures associated with neurovascular complications
* Fractures associated with compartment syndrome
* Repeat femoral surgeries
* Patients who received a femoral nerve block more than 1 hour prior to surgery
* Complex associated injuries or pre-existing condition that will delay time to ambulation
* Children who are allergic and/or sensitive to bupivacaine

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No