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This single-center randomized controlled trial was designed to compare epinephrine-added irrigation fluid with an intravenous tranexamic acid (TXA) protocol during arthroscopic rotator cuff repair. The primary outcome measure was surgeon-rated surgical field visibility. Secondary outcome measures included arthroscopic pump pressure, total irrigation volume, and early postoperative shoulder soft-tissue edema assessed at 24 hours.
Patients undergoing primary arthroscopic rotator cuff repair were randomized in a 1:1 ratio to receive either epinephrine-added irrigation fluid (0.33 mg/L) or an intravenous TXA regimen consisting of a 15 mg/kg bolus administered 10 minutes before surgery followed by a continuous infusion of 10 mg/kg/hour during the procedure. A pressure-controlled arthroscopic pump system was used in all cases according to a standardized protocol. Surgical field visibility was assessed using a 0-10 visual analog scale (VAS). In addition, recorded arthroscopic videos were independently evaluated by a second surgeon who was blinded to treatment allocation. Early postoperative soft-tissue edema was quantified by measuring axillary and deltoid circumferences preoperatively and at 24 hours postoperatively.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Umraniye Training and Research Hospital
Istanbul, Turkey (Türkiye)
Start Date
May 1, 2021
Primary Completion Date
December 31, 2023
Completion Date
December 31, 2023
Last Updated
March 2, 2026
80
ACTUAL participants
Epinephrine in irrigation fluid
DRUG
Tranexamic acid, intravenous
DRUG
Lead Sponsor
Saglik Bilimleri Universitesi
NCT04944836
NCT06735170
NCT07057037
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