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Treatment for Shoulder Arthroscopy
Phase 4
Waitlist Available
Led By James M Gregory, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergo arthroscopic shoulder surgery in the seated upright (beach-chair) position requiring visualization within the subacromial space
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of surgery(about 30-120 minutes from start of surgery)
Awards & highlights
Study Summary
The purpose of this study is to evaluate surgeon-rated visual clarity and the need for increased irrigation pump pressure during arthroscopic shoulder surgery and to evaluate mean arterial pressure, operative time, and any adverse events that occur during arthroscopic shoulder surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of surgery(about 30-120 minutes from start of surgery)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of surgery(about 30-120 minutes from start of surgery)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure
Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale
Secondary outcome measures
Intraoperative Mean Arterial Pressure
Number of Subjects Who Experience Intraoperative Adverse Events
Number of Subjects Who Experience Post Operative Adverse Events
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine with Epinephrine
2013
Completed Phase 4
~90
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,917 Total Patients Enrolled
James M Gregory, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
70 Total Patients Enrolled
Frequently Asked Questions
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