Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

Phase 4

Completed

• Conditions: Shoulder Arthroscopy
• Interventions: Drug: Bupivacaine with Epinephrine; Drug: Bupivacaine alone

• Registration Number: NCT05244525
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-17
• Study Start: 2022-03-14
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Results First Submitted: 2023-08-17
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-10
• Last Update Submitted: 2023-10-10
• Results First Posted: 2023-11-03
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Bupivacaine with Epinephrine	-
Control Group	Bupivacaine alone	-

Primary Outcome Measures

Name	Time	Method
Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale	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	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States