Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

Study Overview
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Brief Summary
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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.

Official Title
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Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

Conditions
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Shoulder Arthroscopy

Intervention / Treatment
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* Drug: Bupivacaine with Epinephrine
* Drug: Bupivacaine alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Drug: Bupivacaine with Epinephrine<br>* 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.<br>|
| Active Comparator: Control Group<br> | Drug: Bupivacaine alone<br>* 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.<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Rotator Cuff, Epinephrine, Subacromial bursa