Epinephrine group
DrugIrrigation 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.
NCT Number: NCT07349407
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.
Trial opening soon.
Get Notified15 year–65 year
All sexes
Interventional
Not applicable
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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.
Standard tourniquet application
Time frame: at 2 hours
Scores are integers ranging from 0 to 4, with higher scores indicating clearer visual field
Time frame: at 2 and 24 hours postoperatively
Scores range from 0 to 10, with higher scores indicating more severe pain
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
The Effect of Dilute Epinephrine Saline Irrigation on Field Clarity in Ankle Arthroscopic Surgery Compared to a Tourniquet: a Double-blind, Randomized Controlled Trial
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