Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment
Intervention: Bupivacaine with Epinephrine (Drug)
Control Group
Intervention: Bupivacaine alone (Drug)
Outcomes
Primary Outcomes
Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale
Time Frame: end of surgery(about 30-120 minutes from start of surgery)
This scale is scored from 1-10, a higher number indicating better clarity
Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure
Time Frame: From start of surgery to end of surgery(about 30-120 minutes)
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.
Secondary Outcomes
- Intraoperative Mean Arterial Pressure(end of surgery(about 30-120 minutes from start of surgery))
- Number of Subjects Who Experience Intraoperative Adverse Events(end of surgery(about 30-120 minutes from start of surgery))
- Total Operative Time(end of surgery(about 30-120 minutes from start of surgery))
- Number of Subjects Who Experience Post Operative Adverse Events(from the end of surgery up to 2 weeks post surgery)
Investigators
James M. Gregory
Associate Professor
The University of Texas Health Science Center, Houston