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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Emergency Room Visits
Opioid Consumption
Pain Scores

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
93 Previous Clinical Trials
184,573 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility threshold for this research trial limited to individuals over twenty-five years of age?

"According to the prerequisites for this research, individuals must fall between 5 and 18 years old."

Answered by AI

What clinical issues can be addressed by Single Shot Regional Anesthesia Upper Limb Surgery?

"Single Shot Regional Anesthesia Upper Limb Surgery is a common method of anesthesia treatment, but it has also proven to be effective for surgical anesthesia, labour pain management and postoperative analgesia."

Answered by AI

To whom is eligibility for participation in this trial extended?

"To qualify for this clinical experiment, potential participants must have the ability to receive local anesthetic and be between 5 and 18 years of age. This trial is currently accepting up to 88 volunteers in total."

Answered by AI

Has there ever been an investigation into the efficacy of utilizing Single Shot Regional Anesthesia Upper Limb Surgery?

"At present, 58 clinical trials are studying the effects of Single Shot Regional Anesthesia Upper Limb Surgery. Of those, 14 have reached Phase 3 and 79 unique sites throughout the country offer these studies. Jefferson Louisiana has a particularly high concentration of such experiments."

Answered by AI

To what extent is enrollment being accepted for this experiment?

"Unfortunately, this clinical trial is not currently open for enrolment. Initially posted on February 20th 2021 and last edited on the 5th of that same month, it appears to be inactive at present. Fortunately, 231 trials related to local anaesthesia are actively recruiting participants along with 58 additional studies focusing specifically Single Shot Regional Anesthesia Upper Limb Surgery."

Answered by AI

Are there still spots open in this clinical research project?

"This medical trial, which was established on February 20th 2021 and updated lastly on the 5th of February, is not recruiting patients at this juncture. Nevertheless, there are 289 other clinical trials that are open for recruitment presently."

Answered by AI
~0 spots leftby May 2024