The Effect of Intravenous Versus Intra-articular Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Prospective, Randomized, Double-blind Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Intraoperative visual clarity
Study Overview
Brief Summary
This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with full-thickness rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The operating surgeon (outcome assessor) and the patient were blinded to group allocation. Study drug and irrigation fluid were prepared in a separate room by a circulating nurse; only the anesthesia team administering the intravenous agent was aware of allocation.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-80 years
- •Diagnosed with a rotator cuff tear
- •Failure of conservative treatment for more than 3 months
- •Rotator cuff deemed repairable on magnetic resonance imaging
Exclusion Criteria
- •Known hypersensitivity to tranexamic acid
- •Previous cerebrovascular accident
- •Coronary stent or other history of thromboembolic disease
- •Anticoagulant therapy
- •Uncontrolled hypertension (systolic pressure > 180 mmHg)
- •Abnormal prothrombin time or activated partial thromboplastin time
- •Acute traumatic rotator cuff tear
- •Irreparable rotator cuff tear
Outcomes
Primary Outcomes
Intraoperative visual clarity
Time Frame: Intraoperatively, at the end of each of the six surgical stages
Surgeon-rated clarity of the arthroscopic surgical field on a 0-10 numeric scale (0 = poorest visualization, 10 = optimal visualization), scored at the end of each of six surgical stages: glenohumeral procedure, subacromial bursectomy, acromioplasty, rotator cuff inspection, medial-row repair, and lateral-row repair.
Secondary Outcomes
- Estimated blood loss(From immediately before surgery to immediately after the end of surgery)
- Total operative time(Intraoperative (duration of surgery))
- Irrigation-fluid volume(Intraoperatively, from skin incision to skin closure (duration of surgery))
- Number of irrigation-pressure increases(Intraoperatively, from skin incision to skin closure (duration of surgery))
- Postoperative shoulder swelling(Baseline (pre-operative) and postoperative day 1)
- Postoperative pain(Pain assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse outcome, on postoperative day 1)