NCT07442643

Epinephrine-Added Irrigation Versus Intravenous Tranexamic Acid in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Saglik Bilimleri Universitesi · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
DRUG	Epinephrine in irrigation fluid	Description: Epinephrine added to irrigation fluid at a concentration of 0.33 mg/L during arthroscopic rotator cuff repair.
DRUG	Tranexamic acid, intravenous	Description: Intravenous tranexamic acid administered as a 15 mg/kg bolus before surgery followed by continuous infusion at 10 mg/kg/hour during arthroscopic rotator cuff repair.

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: Turkey (Türkiye)