Purpose: The study aimed to determine whether intravenous administration of tanexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity. Methods: This is a prospective, double-blinded, randomized and placebo-controlled study. From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair were enrolled and randomly assigned to either the TXA group that received 1000mg tranexamic acid intravenously 10 minutes before surgery or the placebo group that received the same volume of plain saline. Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anti-coagulation medications were excluded. The visual clarity was rated by a numeric rating scale from grade 1(poor) to grade 3(clear) every 15 minutes throughout the surgery. Secondary outcomes included estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration and associated comorbidities were recorded. Both parametric and nonparametric methods were used for statistical analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Tranexamic acid (TXA) is a synthetic analog of the amino acid lysine which acts by competitively blocking the plasminogen lysine-binding site and inhibiting fibrinolysis. Several studies showed that TXA could reduce both blood loss and the amount of blood transfusion after shoulder arthroplasty surgeries.
Normal saline is a mixture of sodium chloride in water and has a number of uses in medicine. We use the same volume of normal saline as placebo.
National Cheng Kung University Hospital
Tainan, Taiwan
Visual clarity during shoulder arthroscopic surgery.
We use 3-grades visual clarity. grade 1 means poor visual clarity; 2 means fair clarity and 3 means good clarity. The visual clarity was scored in every 15 minutes during the operation scoring system to evaluate visual clarity during arthroscopic surgery. 4 Grade 1 means poor visibility (active bleeding that the vision was too poor to perform the operation); Grade 2 means fair visibility (minor bleeding that can interfere vision but surgery can still perform); Grade 3 means good visibility (clear vision without obvious blood).
Time frame: Measure the percentage of grade 3 visual clarity after surgery through study completion, an average of 1 year.
Visual clarity during shoulder arthroscopic surgery.
We use 3-grades visual clarity. grade 1 means poor visual clarity; 2 means fair clarity and 3 means good clarity. The visual clarity was scored in every 15 minutes during
Time frame: Measure the whole surgery's mean visual clarity grade after surgery through study completion, an average of 1 year.
patients' visual analog scale (VAS ) pain score on postoperative day 1
The visual analog scale(VAS) for pain is a continuous scale comprised of a horizontal line, which was 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme (from 0 cm means no pain to 10cm means worst pain possible) for patients self-assessment of pain.
Time frame: measure on post operative day one's morning through study completion, an average of 1 year.
post operation shoulder swelling
(compared the circumference of shoulder post op day 1 to the day of admission which were measured at two sites: axillary and deltoid),
Time frame: measure on post operative day one's morning through study completion, an average of 1 year.
change of serum hemoglobin before and after operation
use the change of Hb to calculate estimate blood loss by Gross formula.
Time frame: measure on post operative day one's morning through study completion, an average of 1 year.
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