Phase 4
N=60
Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy
Shoulder Arthroscopy
Bottom Line
View on ClinicalTrials.gov: NCT05244525 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale — 8.3; 7.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine with Epinephrine (Drug); Bupivacaine alone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale |
8.3; 7.5 | — |
| PRIMARY Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure |
22; 23 | — |
| SECONDARY Intraoperative Mean Arterial Pressure |
70.5; 71.3 | — |
| SECONDARY Total Operative Time |
62; 64 | — |
| SECONDARY Number of Subjects Who Experience Intraoperative Adverse Events |
0; 0 | — |
| SECONDARY Number of Subjects Who Experience Post Operative Adverse Events |
0; 0 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT05244525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.