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Clinical trial

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

ID
Name
2310-72
Description
The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery.
Trial arms
Trial start
2024-04-01
Estimated PCD
2025-04-01
Trial end
2026-04-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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
Arms:
Epinephrine
Other names:
Epinephrine in irrigation fluid
Normal Saline irrigation fluid
The control group will have two 3-L normal saline solution bags prepared with no additive
Arms:
Epinephrine, Normal saline
Size
78
Primary endpoint
visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale
intraoperative
surgeon's discomfort related to bleeding, measured by visual numeric rating scale
intraoperative
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Concealed irrigation bags', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 78, 'type': 'ESTIMATED'}}
Updated at
2024-02-22

1 organization

1 product

1 indication

Organization
The Guthrie Clinic
Product
Epinephrine
Indication
Intraoperative Bleeding