NCT07349407

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

The Effect of Dilute Epinephrine Saline Irrigation on Field Clarity in Ankle Arthroscopic Surgery Compared to a Tourniquet: a Double-blind, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Chronic Ankle Instability
• Ankle Ligament Injury
• Ankle Arthroscopy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-30
• Primary completion: 2026-11-30
• Completion: 2026-12-30
• First posted: 2026-01-16
• Last updated: 2026-01-16