Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

Shoulder Arthroscopy Clinical Trial

Official title:

Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244525
• Other study ID #: HSC-MS-21-1061
• Status: Completed
• Phase: Phase 4
• Start date: March 14, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Arthroscopy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Intraoperative Mean Arterial Pressure		end of surgery(about 30-120 minutes from start of surgery)
Secondary	Total Operative Time		end of surgery(about 30-120 minutes from start of surgery)
Secondary	Number of Subjects Who Experience Intraoperative Adverse Events		end of surgery(about 30-120 minutes from start of surgery)
Secondary	Number of Subjects Who Experience Post Operative Adverse Events		from the end of surgery up to 2 weeks post surgery