Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery

Phase 3

Withdrawn

• Conditions: Intraoperative Bleeding
• Interventions: Drug: Epinephrine; Procedure: Normal Saline irrigation fluid

• Registration Number: NCT06264596
• Lead Sponsor: The Guthrie Clinic

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-20
• Study Start: 2024-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epinephrine	Normal Saline irrigation fluid	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).
Normal saline	Normal Saline irrigation fluid	The control group will have two 3-L normal saline solution bags prepared with no additive
Epinephrine	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).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Robert Packer Hospital; 🇺🇸 Sayre, Pennsylvania, United States