Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery

NCT ID: NCT06264596

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Intraoperative Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Concealed irrigation bags

Study Groups

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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).

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

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

Normal Saline irrigation fluid

Intervention Type PROCEDURE

The control group will have two 3-L normal saline solution bags prepared with no additive

Normal saline

The control group will have two 3-L normal saline solution bags prepared with no additive

Group Type PLACEBO_COMPARATOR

Normal Saline irrigation fluid

Intervention Type PROCEDURE

The control group will have two 3-L normal saline solution bags prepared with no additive

Interventions

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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

Intervention Type DRUG

Normal Saline irrigation fluid

The control group will have two 3-L normal saline solution bags prepared with no additive

Intervention Type PROCEDURE

Other Intervention Names

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Epinephrine in irrigation fluid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Guthrie Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wonyong Lee, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Locations

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Robert Packer Hospital

Sayre, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2310-72

Identifier Type: -

Identifier Source: org_study_id

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