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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Drug: Epinephrine in irrigation fluid; Drug: Tranexamic acid, intravenous

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34766
    • Ümraniye Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-70 years
• MRI-confirmed full-thickness rotator cuff tear
• Planned primary arthroscopic rotator cuff repair
• Written informed consent obtained

Exclusion Criteria:

• Age >70 years
• Advanced cardiovascular disease (advanced heart failure, uncontrolled hypertension, active ischemic heart disease)
• Significant renal impairment
• History of thromboembolic disease
• Contraindication to tranexamic acid
• Irreparable massive tear with advanced fatty degeneration or severe muscle atrophy
• Revision surgery
• Planned concomitant open surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM 1: Epinephrine-Added Irrigation Group; Participants underwent arthroscopic rotator cuff repair using irrigation fluid containing epinephrine at a concentration of 0.33 mg/L throughout the procedure.	Drug: Epinephrine in irrigation fluid; Description: Epinephrine added to irrigation fluid at a concentration of 0.33 mg/L during arthroscopic rotator cuff repair.
Experimental: ARM2: Intravenous Tranexamic Acid (TXA) Group; Participants received an intravenous tranexamic acid protocol consisting of a 15 mg/kg bolus administered 10 minutes before surgery, followed by continuous infusion at 10 mg/kg/hour 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical field visibility	Surgical field visibility assessed using a 0-10 visual analog scale (VAS), calculated as the mean of scores independently assigned by two surgeons.	Intraoperative (during arthroscopic rotator cuff repair)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arthroscopic pump pressure (mmHg)	Mean pressure setting of the pressure-controlled arthroscopic pump during the procedure, recorded in mmHg according to the standardized intraoperative protocol.	Intraoperative (during procedure; mean value recorded)
Total irrigation volume (liters)	Total volume of irrigation fluid used during arthroscopic rotator cuff repair, recorded in liters as the cumulative amount of irrigation bags consumed intraoperatively.	Intraoperative (total volume used during procedure)
Axillary circumference change (cm)	Change in axillary circumference on the operated side, calculated as postoperative 24-hour measurement minus the preoperative measurement (cm), obtained using a flexible tape measure with a standardized technique.	Preoperative and postoperative 24 hours
Deltoid circumference change (cm)	Change in deltoid circumference on the operated side, calculated as postoperative 24-hour measurement minus the preoperative measurement (cm), obtained using a flexible tape measure with a standardized technique.	Preoperative and postoperative 24 hours
Early postoperative complications	Incidence of early postoperative adverse events potentially related to the interventions, including cardiac arrhythmia, thromboembolic events, neurologic deficit, or allergic reactions, assessed during the immediate postoperative period.	Up to 24 hours postoperatively (or during hospitalization)
Body temperature at 24 hours (°C)	Body temperature measured at postoperative 24 hours (°C) as part of routine postoperative monitoring.	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: tranexamic acid; epinephrine; shoulder arthroscopy; rotator cuff repair
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Amines; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Acids, Carbocyclic; Biogenic Monoamines; Biogenic Amines; Catecholamines; Cyclohexanecarboxylic Acids; Tranexamic Acid; Epinephrine
• Other Study ID Numbers: RCR-TXA-EPINEPHRINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No