Trial Summary
What is the purpose of this trial?This trial is testing a procedure where pain medication is injected near neck nerves to manage pain after shoulder surgery. It targets healthy adolescents having shoulder reconstruction. The treatment works by numbing the nerves to block pain signals, helping reduce the need for other painkillers and speeding up recovery. This method has been found to be the most effective way to control pain after shoulder surgery.
Eligibility Criteria
This trial is for individuals aged 10-21 years with shoulder injuries requiring surgery, who are in good health (ASA I-II). They must consent to a nerve block and not have other surgeries at the same time. Excluded are those with severe health issues, pre-op sedation, allergies to local anesthetics, or conditions making them unsuitable for the study.Inclusion Criteria
I am in good or mild systemic disease condition according to ASA.
I am between 10 and 21 years old.
I have agreed to a specific type of anesthesia for my procedure, and a qualified clinician not involved in the study has obtained my consent.
I am scheduled for a one-sided shoulder surgery under general anesthesia without any other surgeries.
Exclusion Criteria
I am having more than one surgery at the same time.
My health status is considered to be more than mildly compromised.
I will be given sedation before surgery.
Treatment Details
The study compares different timings of administering a nerve block—either before or after shoulder surgery—to see which method better reduces post-operative pain. Participants will receive either a single shot or continuous catheter-delivered nerve blockade.
4Treatment groups
Active Control
Group I: Preemptive Interscalene Block - Single ShotActive Control1 Intervention
Group II: Postoperative Interscalene Block - Single ShotActive Control1 Intervention
Group III: Preemptive Interscalene Block - CatheterActive Control1 Intervention
Group IV: Postoperative Interscalene Block - CatheterActive Control1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
Cincinnati Children's Hospital Medical CenterCincinnati, OH
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor