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Local Anesthetic Volume for Postoperative Pain
Study Summary
This trial looks at a new way to do nerve block procedures, considering both the success and side effects of the block.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am eligible for keyhole surgery on my shoulder.You have been using opioid medication for a long time.I have limited movement in my limbs due to past health issues.I do not have significant nerve pain or damage.I am not advised against nerve block anesthesia due to health reasons.I have an infection where I received an injection or where my catheter was placed.I have a history of serious lung problems.You weigh less than 40 kilograms for every square meter of your height.You are allergic to ropivacaine.You have a low to moderate risk for surgical complications based on your overall health.I am unable to understand and give consent for treatment.I am older than 18 years.
- Group 1: Brachial Plexus Block Group 1
- Group 2: Brachial Plexus Group 3
- Group 3: Brachial Plexus Group 2
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Frequently Asked Questions
What is the current regulatory status of Brachial Plexus Block Group 1?
"Given the Phase 4 trial status, our experts at Power assigned Brachial Plexus Block Group 1 a rating of 3 to reflect its established safety profile."
Is there availability for participation in this experiment?
"As evidenced by the information on clinicaltrials.gov, this research study is actively seeking qualified participants. The original posting was made on February 17th 2023 and most recently updated on May 11th 2023."
What is the cohort size for this experimental protocol?
"Affirmative. According to the available information on clinicaltrials.gov, this research is currently recruiting participants with an initial posting date of February 17th 2023 and a most recent edit on May 11th 2023. The study requires 150 people from 1 medical site."
What end-results is this research attempting to realize?
"This 60-minute study looks to assess Lung Function, as well as gauge Vital Capacity (in L), Pulse Oximetry changes, and the rate of Dyspnea/Horner's/Hoarseness side effects."
Who else is applying?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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