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NCT Number: NCT07442643

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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umraniye Training and Research Hospital

Istanbul, 34766, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epinephrine in irrigation fluid

Drug

Description: Epinephrine added to irrigation fluid at a concentration of 0.33 mg/L during arthroscopic rotator cuff repair.

Tranexamic acid, intravenous

Drug

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.

Primary outcomes

  1. Surgical field visibility

    Time frame: Intraoperative (during arthroscopic rotator cuff repair)

    Surgical field visibility assessed using a 0-10 visual analog scale (VAS), calculated as the mean of scores independently assigned by two surgeons.

Secondary outcomes

  1. Mean arthroscopic pump pressure (mmHg)

    Time frame: Intraoperative (during procedure; mean value recorded)

    Mean pressure setting of the pressure-controlled arthroscopic pump during the procedure, recorded in mmHg according to the standardized intraoperative protocol.

  2. Total irrigation volume (liters)

    Time frame: Intraoperative (total volume used during procedure)

    Total volume of irrigation fluid used during arthroscopic rotator cuff repair, recorded in liters as the cumulative amount of irrigation bags consumed intraoperatively.

  3. Axillary circumference change (cm)

    Time frame: Preoperative and postoperative 24 hours

    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.

  4. Deltoid circumference change (cm)

    Time frame: Preoperative and postoperative 24 hours

    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.

  5. Early postoperative complications

    Time frame: Up to 24 hours postoperatively (or during hospitalization)

    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.

  6. Body temperature at 24 hours (°C)

    Time frame: Postoperative 24 hours

    Body temperature measured at postoperative 24 hours (°C) as part of routine postoperative monitoring.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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