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NCT06264596 Clinical Trial

Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery

Intraoperative Bleeding Clinical Trial

Official title:
The Effect of Epinephrine in Irrigation Fluid for Visualization During Ankle Arthroscopy: A Randomized Blinded Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06264596
Other study ID # 2310-72
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date April 2024
Est. completion date April 2026

Study information
Verified date February 2024
Source The Guthrie Clinic
Contact Wonyong Lee, MD
Phone 570-887-4882
Email wonyong.lee@guthrie.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery.

Description:

The primary outcomes are: - visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale from 0-10, - and the intraoperative surgeon's discomfort related to bleeding, that will be measured by visual numeric rating scale from 0-3.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 78
Est. completion date April 2026
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males and Females ages over 18 years - Patients who undergo ankle arthroscopic surgery - Patients who are able to read and give informed consent on their own behalf Exclusion Criteria: - Patients with any known cardiac diseases - Uncontrolled hypertension (> 180/110 mmHg) - Revision case - Younger than 18 years of age - Pregnant women

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Epinephrine
The epinephrine group will have two 3-L normal saline solution bags prepared for each case with 1 mL of 1:1000 epinephrine in each bag
Procedure:
• Normal Saline irrigation fluid
The control group will have two 3-L normal saline solution bags prepared with no additive

Locations
Country Name City State
United States Robert Packer Hospital Sayre Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale visual analog scale from 0-10 intraoperative
Primary surgeon's discomfort related to bleeding, measured by visual numeric rating scale visual numeric rating scale 0-3 intraoperative
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