Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

NCT05244525 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-21-1061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthroscopy

Keywords

Shoulder; Rotator Cuff; Epinephrine; Subacromial bursa

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Treatment

EXPERIMENTAL

Drug: Bupivacaine with Epinephrine

Control Group

ACTIVE COMPARATOR

Drug: Bupivacaine alone

Interventions

Bupivacaine with Epinephrine DRUG

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.

Treatment

Bupivacaine alone DRUG

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergo arthroscopic shoulder surgery in the seated upright (beach-chair) position requiring visualization within the subacromial space

You may not qualify if:

• Are unable to provide informed consent
• Non-English speaker
• Have a history of adverse medication reaction to epinephrine

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Feinstein S, Svetgoff RA, Harmon J, Siahaan J, Ngo DH, Fullick RK, Flores SE, Shupe PG, Gregory BP, Gregory JM. Effect of a Preoperative Subacromial Epinephrine Injection on Visualization During Shoulder Arthroscopic Surgery: A Randomized Controlled Trial. Orthop J Sports Med. 2024 Oct 10;12(10):23259671241278247. doi: 10.1177/23259671241278247. eCollection 2024 Oct.

  PMID: 39399770 DERIVED

MeSH Terms

Interventions

Bupivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: James M. Gregory, MD
• Organization: The University of Texas Health Science Center at Houston

James.M.Gregory@uth.tmc.edu

(713) 486-7500

Study Officials

• James M Gregory, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: March 14, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 3, 2023
• Results First Posted: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)