Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery

NCT06264596 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 2310-72
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraoperative Bleeding

Outcome Measures

Primary Outcomes (2)

• visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale

  visual analog scale from 0-10

  intraoperative

• surgeon's discomfort related to bleeding, measured by visual numeric rating scale

  visual numeric rating scale 0-3

  intraoperative

Study Arms (2)

Epinephrine

EXPERIMENTAL

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; Procedure: Normal Saline irrigation fluid

Normal saline

PLACEBO COMPARATOR

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

Procedure: Normal Saline irrigation fluid

Interventions

Epinephrine 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

Also known as: Epinephrine in irrigation fluid

Epinephrine

Normal Saline irrigation fluid PROCEDURE

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

Epinephrine; Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with any known cardiac diseases
• Uncontrolled hypertension (\> 180/110 mmHg)
• Revision case
• Younger than 18 years of age
• Pregnant women

Sponsors & Collaborators

• The Guthrie Clinic: lead

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Wonyong Lee, MD

  The Guthrie Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Concealed irrigation bags
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)