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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05244525
Other study ID # HSC-MS-21-1061
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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