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NCT Number: NCT07349407

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

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.

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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Epinephrine group

Drug

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.

Tourniquet group

Device

Standard tourniquet application

Primary outcomes

  1. Visual field clarity (VFC) under ankle arthroscopy, assessed using a 4-point Likert-style numeric rating scale (NRS)

    Time frame: at 2 hours

    Scores are integers ranging from 0 to 4, with higher scores indicating clearer visual field

Secondary outcomes

  1. Pain intensity at 2 and 24 hours postoperatively, assessed using the Visual Analog Scale (VAS)

    Time frame: at 2 and 24 hours postoperatively

    Scores range from 0 to 10, with higher scores indicating more severe pain

Study contacts

Contact information is provided by the study sponsor or research team.

zongyou Pan, Doctoral degree

CONTACT

[email protected]

86-19857004757

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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