Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

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 Overview

• Status: Completed
• Conditions: Shoulder Arthroscopy
• Intervention / Treatment: Drug: Bupivacaine with Epinephrine; Drug: Bupivacaine alone

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	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.
Active Comparator: Control Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale	This scale is scored from 1-10, a higher number indicating better clarity	end of surgery(about 30-120 minutes from start of surgery)
Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure	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.	From start of surgery to end of surgery(about 30-120 minutes)

Secondary Outcome Measures

Outcome Measure	Time Frame
Intraoperative Mean Arterial Pressure	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 Intraoperative Adverse Events	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: James M Gregory, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Shoulder; Epinephrine; Rotator Cuff; Subacromial bursa
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: HSC-MS-21-1061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No