Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery

The Guthrie Clinic

Status and phase: Withdrawn; Phase 3

Conditions: Intraoperative Bleeding

Treatments: Drug: Epinephrine; Procedure: Normal Saline irrigation fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT06264596

2310-72

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Epinephrine

Experimental group

Description:

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).

Treatment:

Procedure: Normal Saline irrigation fluid

Drug: Epinephrine

Normal saline

Placebo Comparator group

Description:

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

Treatment:

Procedure: Normal Saline irrigation fluid