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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 168 hours post-operatively.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 168 hours post-operatively.
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
185,123 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my spine.I need a follow-up surgery for my previous orthopedic operation.I am having surgery on my bones or joints that doesn't require a hospital stay.I am having orthopedic surgery and will get regional anesthesia.I am either younger than 5 or older than 18 years old.I am having an orthopedic surgery where a specific type of pain block is standard.I am scheduled for or have had an inpatient orthopedic surgery.I am having surgery on my limb that might lead to increased pressure in my muscles.I am having surgery on my arm or leg.
Research Study Groups:
This trial has the following groups:- Group 1: Single Shot Regional Anesthesia Upper Limb Surgery
- Group 2: Continuous Regional Anesthesia Lower Limb Surgery
- Group 3: Single Shot Regional Anesthesia Lower Limb Surgery
- Group 4: Continuous Regional Anesthesia Upper Limb Surgery
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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