Chronic Ankle InstabilityNCT07349407
Dilute Epinephrine vs Tourniquet for Visualization in Ankle Arthroscopy: A RCT
A study testing Epinephrine group and Tourniquet group in people with Chronic Ankle Instability and Ankle Ligament Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Chronic Ankle Instability, Ankle Ligament Injury, Ankle Arthroscopy
- What is being tested?
- Epinephrine group and Tourniquet group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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).
- Being tested
- Epinephrine group, Tourniquet group
- Keywords
- Arthroscopic visual field
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine groupDrug
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 groupDevice
Standard tourniquet application
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine group | Experimental | Not described Receives: Drug: Epinephrine group |
| Tourniquet group | Active comparator | Not described Receives: Device: Tourniquet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 2 hours
Secondary outcomes (1)
Pain intensity at 2 and 24 hours postoperatively, assessed using the Visual Analog Scale (VAS)
Scores range from 0 to 10, with higher scores indicating more severe pain
Measured: at 2 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start30 Dec 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349407
- Sponsor's protocol ID
- 2025-1632
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07349407
- Acronym / sponsor ID
- 2025-1632
- Keywords
- Arthroscopic visual field
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinephrine group | Experimental | Drug: Epinephrine group |
| Tourniquet group | Active comparator | Device: Tourniquet group |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine groupIrrigation 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. | Drug | Epinephrine group |
| Tourniquet groupStandard tourniquet application | Device | Tourniquet group |
Primary outcome
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
1 secondary outcome
Pain intensity at 2 and 24 hours postoperatively, assessed using the Visual Analog Scale (VAS)
Time frame: at 2 and 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Ankle Instability
Recruiting
Neurocognitive Enrichment During Functional Performance Testing in Chronic Ankle Instability
Chronic Ankle Instability, CAI
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine group and Tourniquet group in people with Chronic Ankle Instability and Ankle Ligament Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zongyou Pan, Doctoral degree (86-19857004757, panzongyou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field clarity (VFC) under ankle arthroscopy, assessed using a 4-point Likert-style numeric rating scale (NRS) (time frame: at 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.