Rotator Cuff Tear
Conditions
Keywords
rotator cuff repair, shoulder arthroscopy, epinephrine, tranexamic acid
Brief 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.
Interventions
DRUGEpinephrine in irrigation fluid
Description: Epinephrine added to irrigation fluid at a concentration of 0.33 mg/L during arthroscopic rotator cuff repair.
DRUGTranexamic 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.
Sponsors
Saglik Bilimleri Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
No additional parties were masked other than the blinded outcome assessor.
Intervention model description
Parallel assignment design in which participants were randomized to receive either epinephrine-added irrigation or an intravenous tranexamic acid protocol during arthroscopic rotator cuff repair.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical field visibility | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean arthroscopic pump pressure (mmHg) | 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. |
| Total irrigation volume (liters) | 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. |
| Axillary circumference change (cm) | 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. |
| Deltoid circumference change (cm) | 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. |
| Early postoperative complications | 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. |
| Body temperature at 24 hours (°C) | Postoperative 24 hours | Body temperature measured at postoperative 24 hours (°C) as part of routine postoperative monitoring. |
Countries
Turkey (Türkiye)
Outcome results
None listed