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

NCT07349407 | Not Yet Recruiting

• 1 other identifier: 2025-1632
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Ankle Instability; Ankle Ligament Injury; Ankle Arthroscopy

Keywords

Arthroscopic visual field

Outcome Measures

Primary Outcomes (1)

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

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

  at 2 hours

Secondary Outcomes (1)

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

  at 2 and 24 hours postoperatively

Study Arms (2)

Epinephrine group

EXPERIMENTAL

Drug: Epinephrine group

Tourniquet group

ACTIVE COMPARATOR

Device: Tourniquet group

Interventions

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.

Epinephrine group

Tourniquet group DEVICE

Standard tourniquet application

Tourniquet group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Central Study Contacts

zongyou Pan, Doctoral degree

CONTACT

86-19857004757; panzongyou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study was conducted using a double-blind design. After concealed randomization, only the principal investigator had access to group assignments, while participants, observers, and surgeons were blinded and identified solely by subject numbers. Upon enrollment and signing of informed consent, participants were informed that they would be randomly assigned to either the epinephrine group or the tourniquet group. Observers received only the corresponding subject numbers from the principal investigator and were responsible for data collection and recording without knowledge of group allocation. For surgeons, both groups had an inflatable tourniquet placed at the standard position prior to surgery. After verification by all three parties (participant, investigator, and surgical team), the surgeon left the room for 15 minutes. Group-specific interventions (inflating the tourniquet or not) were implemented after surgical draping was completed. Surgeons were then called in to perform th
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 16, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share