Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery

February 20, 2024 updated by: The Guthrie Clinic

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Robert Packer Hospital
        • Contact:
        • Principal Investigator:
          • Wonyong Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 (epinephrine concentration 1:3,000,000 for each bag).
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
Other Names:
  • Epinephrine in irrigation fluid
Procedure: Normal Saline irrigation fluid
The control group will have two 3-L normal saline solution bags prepared with no additive
Placebo Comparator: Normal saline
The control group will have two 3-L normal saline solution bags prepared with no additive
Procedure: Normal Saline irrigation fluid
The control group will have two 3-L normal saline solution bags prepared with no additive

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Guthrie Clinic

Investigators

  • Principal Investigator: Wonyong Lee, MD, The Guthrie Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2310-72

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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