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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1: Epinephrine-Added Irrigation Group | Active Comparator | Participants underwent arthroscopic rotator cuff repair using irrigation fluid containing epinephrine at a concentration of 0.33 mg/L throughout the procedure. |
|
| ARM2: Intravenous Tranexamic Acid (TXA) Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine in irrigation fluid | Drug | Description: Epinephrine added to irrigation fluid at a concentration of 0.33 mg/L during arthroscopic rotator cuff repair. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umraniye Training and Research Hospital | Istanbul | 34766 | Turkey (Türkiye) |
Individual participant data will not be shared.
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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.
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No additional parties were masked other than the blinded outcome assessor.
| 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. |
|
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 |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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