NCT05244525

Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

Completed Phase 4 Results posted Last updated 3 November 2023

What this trial tests

Phase 4 trial testing Bupivacaine with Epinephrine in Shoulder Arthroscopy in 60 participants. Completed in 31 August 2022.

Timeline

14 March 2022

Primary endpoint
31 August 2022

31 August 2022

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	60
Start date	14 March 2022
Primary completion	31 August 2022
Estimated completion	31 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Bupivacaine with Epinephrine — full drug profile →
• Bupivacaine alone — full drug profile →

Conditions studied

• Shoulder Arthroscopy — all drugs for Shoulder Arthroscopy →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with Shoulder Arthroscopy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale Primary · end of surgery(about 30-120 minutes from start of surgery)

This scale is scored from 1-10, a higher number indicating better clarity

Group	Value	95% CI
Treatment	8.3	± 1.4
Control Group	7.5	± 1.8

Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure Primary · 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.

Group	Value	95% CI
Treatment	22
Control Group	23

Intraoperative Mean Arterial Pressure Secondary · end of surgery(about 30-120 minutes from start of surgery)

Group	Value	95% CI
Treatment	70.5	± 12.7
Control Group	71.3	± 7.3

Total Operative Time Secondary · end of surgery(about 30-120 minutes from start of surgery)

Group	Value	95% CI
Treatment	62	± 19.4
Control Group	64	± 30.1

Number of Subjects Who Experience Intraoperative Adverse Events Secondary · end of surgery(about 30-120 minutes from start of surgery)

Group	Value	95% CI
Treatment	0
Control Group	0

Number of Subjects Who Experience Post Operative Adverse Events Secondary · from the end of surgery up to 2 weeks post surgery

Group	Value	95% CI
Treatment	0
Control Group	0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of a Preoperative Subacromial Epinephrine Injection on Visualization During Shoulder Arthroscopic Surgery: A Randomized Controlled Trial.
   Feinstein S, Svetgoff RA, Harmon J, Siahaan J, et al · · 2024 · cited 2× · PMID 39399770 · DOI 10.1177/23259671241278247