NCT05244525

Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Shoulder Arthroscopy

Interventions

Type	Name	Description
DRUG	Bupivacaine with Epinephrine	Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Study patients will receive an injection containing a total volume of 20 mL of bupivacaine with epinephrine (0.3 mL epinephrine in 30 mL of 0.5% bupivacaine).The syringe will not be labeled, and the contents of the injection will not be disclosed to the surgeon to preserve blinding. The injection will be performed with an 18-gauge needle into the subacromial space via a posterior or lateral approach after positioning the patient in the beach chair position, but prior to prepping and draping.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale. Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded.
DRUG	Bupivacaine alone	Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Control patients will receive an injection containing 20mL of 0.5% bupivacaine alone.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale.Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded.

Timeline

• Start date: 2022-03-14
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2022-02-17
• Last updated: 2023-11-03
• Results posted: 2023-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study