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Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery

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

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06264596
Enrollment
0
Registered
2024-02-20
Start date
2024-08-31
Completion date
2026-08-31
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Bleeding

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.

Interventions

DRUGEpinephrine

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

PROCEDURENormal Saline irrigation fluid

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

Sponsors

The Guthrie Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Concealed irrigation bags

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026