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Regional Anesthesia for Pediatric Orthopedic Disorders

Phase 2 & 3
Recruiting
Research Sponsored by Ochsner Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 168 hours post-operatively.
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial tests different anesthetic techniques to determine if they can reduce pain in kids after surgery and reduce their need for opioid medication.

Who is the study for?
This trial is for children aged 5-18 undergoing their first orthopaedic limb surgery as outpatients. It's not for those having revisions, spine surgeries, ACL reconstructions with established pain care, inpatient procedures, or at risk of compartment syndrome.
What is being tested?
The study tests the effectiveness of Ropivacaine in managing post-surgery pain in kids. It compares continuous nerve blockades to single-shot techniques after limb surgeries to see if they could replace opioids as a standard pain treatment.
What are the potential side effects?
Ropivacaine may cause side effects like numbness around the injection site, weakness or tingling in the affected limb, nausea or vomiting and low blood pressure. Serious side effects are rare but can include seizures or heart problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 168 hours post-operatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 168 hours post-operatively. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Emergency Room Visits
Opioid Consumption
Pain Scores

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Single Shot Regional Anesthesia Upper Limb SurgeryExperimental Treatment1 Intervention
Various types of regional anesthesia blocks involving the brachial plexus will be performed based on the patient's injuries. A catheter will be placed for the given block for 48 hours. Those patients undergoing upper limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.
Group II: Single Shot Regional Anesthesia Lower Limb SurgeryExperimental Treatment1 Intervention
Various types of regional anesthesia blocks will be performed based on the patient's injuries including fascia iliaca plane blocks, femoral nerve blocks, adductor canal blocks, popliteal approach sciatic nerve blocks, and saphenous nerve blocks. These blocks will be given via a single dose or "single shot". Those patients undergoing lower limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.
Group III: Continuous Regional Anesthesia Upper Limb SurgeryExperimental Treatment1 Intervention
Various types of regional anesthesia blocks involving the brachial plexus will be performed based on the patient's injuries. A catheter will be placed for the given block for 48 hours. Those patients undergoing upper limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.
Group IV: Continuous Regional Anesthesia Lower Limb SurgeryExperimental Treatment1 Intervention
Various types of regional anesthesia blocks will be performed based on the patient's injuries including fascia iliaca plane blocks, femoral nerve blocks, adductor canal blocks, popliteal approach sciatic nerve blocks, and saphenous nerve blocks A catheter will be placed for the given block for 48 hours. Those patients undergoing lower limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Ochsner Health SystemLead Sponsor
95 Previous Clinical Trials
89,812 Total Patients Enrolled

Media Library

Single Shot Regional Anesthesia Upper Limb Surgery Clinical Trial Eligibility Overview. Trial Name: NCT04669145 — Phase 2 & 3
Local Anesthesia Research Study Groups: Single Shot Regional Anesthesia Upper Limb Surgery, Continuous Regional Anesthesia Lower Limb Surgery, Single Shot Regional Anesthesia Lower Limb Surgery, Continuous Regional Anesthesia Upper Limb Surgery
Local Anesthesia Clinical Trial 2023: Single Shot Regional Anesthesia Upper Limb Surgery Highlights & Side Effects. Trial Name: NCT04669145 — Phase 2 & 3
Single Shot Regional Anesthesia Upper Limb Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04669145 — Phase 2 & 3
~20 spots leftby Nov 2025
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