Dilute Epinephrine vs Tourniquet for Visualization in Ankle Arthroscopy: A RCT

Zhejiang University

Status

Not yet enrolling

Conditions

Chronic Ankle Instability

Ankle Arthroscopy

Ankle Ligament Injury

Treatments

Drug: Epinephrine group

Device: Tourniquet group

Study type

Interventional

Funder types

Other

Identifiers

NCT07349407

2025-1632

Details and patient eligibility

About

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.

Full 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).

Enrollment

88 estimated patients

Sex

All

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

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)