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Local Anesthetic
Local Anesthetic Volume for Postoperative Pain
Phase 4
Recruiting
Research Sponsored by Benaroya Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgical candidate for Arthroscopic rotator cuff surgery
Age >18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes after surgery
Awards & highlights
Study Summary
This trial looks at a new way to do nerve block procedures, considering both the success and side effects of the block.
Who is the study for?
This trial is for adults over 18 who need arthroscopic rotator cuff surgery, have a BMI under 40, and are generally healthy (ASA I-III). It's not for those with site infections, limb restrictions due to medical history, severe lung disease, ropivacaine allergy, neuropathy, chronic opioid use or if they can't consent in English.Check my eligibility
What is being tested?
The study tests the optimal dose of Ropivacaine (0.5%) for pain relief after shoulder surgery using brachial plexus block. It's a forward-looking study that blinds patients to treatment and uses an innovative method to assess both success rates and potential side effects like lung dysfunction.See study design
What are the potential side effects?
Possible side effects include issues related to lung function as the study specifically monitors this. Other common side effects from Ropivacaine may include nausea, low blood pressure, dizziness or numbness around the injection area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for keyhole surgery on my shoulder.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Block Success
Lung Function
Secondary outcome measures
Diaphragm Excursion
Pulse Oximetry
Side Effects
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Brachial Plexus Group 3Experimental Treatment1 Intervention
Suprascapular
Group II: Brachial Plexus Group 2Experimental Treatment1 Intervention
Supraclavicular
Group III: Brachial Plexus Block Group 1Experimental Treatment1 Intervention
Interscalene
Find a Location
Who is running the clinical trial?
Benaroya Research InstituteLead Sponsor
45 Previous Clinical Trials
11,167 Total Patients Enrolled
1 Trials studying Postoperative Pain
124 Patients Enrolled for Postoperative Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Brachial Plexus Block Group 1
- Group 2: Brachial Plexus Group 3
- Group 3: Brachial Plexus Group 2
Awards:
This trial has 3 awards, including:- 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
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