Dilute Epinephrine vs Tourniquet for Visualization in Ankle Arthroscopy: A RCT (NCT07349407) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Dilute Epinephrine vs Tourniquet for Visualization in Ankle Arthroscopy: A RCT
88 participantsStarted 2025-12-30
Plain-language summary
This multicenter, prospective randomized controlled trial investigates the effect of dilute epinephrine irrigation versus tourniquet use on visual field clarity (VFC) during ankle arthroscopy. Patients are randomized into an epinephrine group (normal saline with 1 mL of 1:1000 epinephrine per 3 L bag; tourniquet placed but not inflated unless needed) or a standard tourniquet group. The primary outcome is arthroscopic visual field clarity assessed using a 4-point Likert-style numeric rating scale. Secondary outcomes include postoperative pain intensity at 2 and 24 hours (VAS), and the incidence of hypotension, bradycardia, and cardiovascular adverse events.
Who can participate
Age range
15 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to understand the procedures and methods of the clinical trial
* voluntarily provide written informed consent
* Aged from 15 to 65 years old , regardless of sex
* Diagnosed with a condition requiring ankle surgery
* Be scheduled to undergo unilateral ankle arthroscopy
Exclusion Criteria:
* Patients who decline to participate in the study
* Known history of heart disease (e.g., coronary artery disease, cardiac conduction abnormalities), diabetes, or asthma
* Poorly controlled hypertension
* Age under 15 years or above 65 years old
* Intellectual disability
* Pregnant or breastfeeding women
* Known allergy to sulfites
Contraindications to ISBPB (including planned injection site infection, pre-existing neurological deficits, allergy to local anesthetics, severe chronic obstructive pulmonary disease, or contralateral phrenic nerve dysfunction)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual field clarity (VFC) under ankle arthroscopy, assessed using a 4-point Likert-style numeric rating scale (NRS)
Timeframe: at 2 hours
Trial details
NCT IDNCT07349407
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University