Dilute Epinephrine vs Tourniquet for Visualization in Ankle Arthroscopy: A RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epinephrine group, Tourniquet group.
- Who it may be relevant to
- Registry conditions: Chronic Ankle Instability, Ankle Ligament Injury, Ankle Arthroscopy. Basic parameters: 15 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Dilute Epinephrine Saline Irrigation on Field Clarity in Ankle Arthroscopic Surgery Compared to a Tourniquet: a Double-blind, Randomized Controlled Trial
Overview
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.
Detailed description
Study Objective and Design
This study aims to evaluate the effect of dilute epinephrine irrigation versus tourniquet use on visual field clarity (VFC) during ankle arthroscopic surgery, while also assessing the incidence of hypotension/bradycardia events and potential cardiovascular adverse effects.
This is a multicenter, prospective, randomized controlled trial comparing the intraoperative arthroscopic field clarity between patients receiving epinephrine-containing irrigation and those undergoing surgery with a tourniquet.
Participants are randomized into two groups:
Epinephrine Group: Irrigation fluid consists of normal saline mixed with 1 mL of 1:1000 epinephrine per 3-liter bag. A tourniquet is placed but not inflated; it may be inflated as a rescue measure if necessary.
Tourniquet Group: Standard tourniquet application as routinely practiced.
3.2.4 Primary Efficacy Outcome
Visual field clarity (VFC) under ankle arthroscopy, assessed using a Likert-style 4-point numeric rating scale (NRS).
3.2.5 Secondary Efficacy Outcomes
Pain intensity scores at 2 and 24 hours postoperatively, measured using the Visual Analog Scale (VAS).
Interventions
- Drug Epinephrine group
Irrigation fluid consisted of normal saline mixed with 1 mL of 1:1000 epinephrine per 3-liter bag. A tourniquet was placed but left deflated as a rescue measure and could be inflated intraoperatively if necessary. - Device Tourniquet group
Standard tourniquet application
Primary outcome measures
- Visual field clarity (VFC) under ankle arthroscopy, assessed using a 4-point Likert-style numeric rating scale (NRS) [Time frame: at 2 hours]
Secondary outcome measures (1)
- Pain intensity at 2 and 24 hours postoperatively, assessed using the Visual Analog Scale (VAS) [Time frame: at 2 and 24 hours postoperatively]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07349407 · 2025-1632