Shoulder Arthroscopy Clinical Trial
Official title:
Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy
Verified date | October 2023 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Undergo arthroscopic shoulder surgery in the seated upright (beach-chair) position requiring visualization within the subacromial space Exclusion Criteria: - Are unable to provide informed consent - Non-English speaker - Have a history of adverse medication reaction to epinephrine |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale | This scale is scored from 1-10, a higher number indicating better clarity | end of surgery(about 30-120 minutes from start of surgery) | |
Primary | Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure | The pump pressure is initially set at 35mmHg during the arthroscopic surgical procedure. If visualization is limited during the procedure, surgeons may increase the pump pressure of arthroscopic fluid within the shoulder during the procedure. This outcome measure reports the percentage of participants for whom intra-operative arthroscopic pump pressure was increased to 45mmHg or higher during the surgical procedure. | From start of surgery to end of surgery(about 30-120 minutes) | |
Secondary | Intraoperative Mean Arterial Pressure | end of surgery(about 30-120 minutes from start of surgery) | ||
Secondary | Total Operative Time | end of surgery(about 30-120 minutes from start of surgery) | ||
Secondary | Number of Subjects Who Experience Intraoperative Adverse Events | end of surgery(about 30-120 minutes from start of surgery) | ||
Secondary | Number of Subjects Who Experience Post Operative Adverse Events | from the end of surgery up to 2 weeks post surgery |
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