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Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT05244525
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
3.6
Anticipated Duration (Months)
16.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine with Epinephrine
  • Drug: Bupivacaine alone
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy
Actual Study Start Date :
Mar 14, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. surgeon-rated visual clarity as assessed by the visual analog scale [end of surgery(about 30-120 minutes from start of surgery)]

    This scale is cored from 1-10, a higher number indicating better clarity

  2. Change in intra-operative arthroscopic pump pressure [end of surgery(about 30-120 minutes from start of surgery)]

Secondary Outcome Measures

  1. Intraoperative mean arterial pressure [end of surgery(about 30-120 minutes from start of surgery)]

  2. total operative time [end of surgery(about 30-120 minutes from start of surgery)]

  3. number of subjects who experience intraoperative adverse events [end of surgery(about 30-120 minutes from start of surgery)]

  4. number of subjects who experience post operative adverse events [end of surgery(about 30-120 minutes from start of surgery)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James M. Gregory, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT05244525
Other Study ID Numbers:
  • HSC-MS-21-1061
First Posted:
Feb 17, 2022
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by James M. Gregory, Associate Professor, The University of Texas Health Science Center, Houston
Shoulder
Rotator Cuff
Epinephrine
Subacromial bursa
Additional relevant MeSH terms:
Epinephrine
Bupivacaine

Study Results

No Results Posted as of May 23, 2022