Tranexamic acid in total shoulder arthroplasty under regional anesthesia: a randomized, single blinded, controlled trial

Garcia, Teresa; Fragão-Marques, Mariana; Pimentão, Pedro; Pinto, Martim; Pedro, Inês; Martins, Carlos

doi:10.1016/j.bjane.2021.02.011

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Original Investigation • para Braz. J. Anesthesiol. 72 (2) • Mar-Apr 2022 • https://doi.org/10.1016/j.bjane.2021.02.011 linkcopy

Tranexamic acid in total shoulder arthroplasty under regional anesthesia: a randomized, single blinded, controlled trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Purpose The purpose of this study was to determine whether Tranexamic Acid (TXA) can significantly reduce perioperative blood loss in Total Shoulder Arthroplasty (TSA) performed under regional anesthesia.

Methods We performed a randomized, single blinded, controlled study. Forty-five patients were submitted to TSA under regional anesthesia to treat cuff tear arthropathy, proximal humeral fractures, chronic instability, primary osteoarthrosis, and failures of previous prosthesis. Patients were randomized to either group TXA therapy (TXA), with 1 g intravenous (IV), or no Intervention (NTXA). Postoperative total drain output, hemoglobin variation, total blood loss, hemoglobin loss, and need for transfusion were measured. Pain-related variables were also assessed: postoperative pain assessment by visual analog scale, inpatient pain breakthrough, quality of recovery, length of stay, and coagulation function testing.

Results Participants presented a mean age of 76 years, 15.6% were male, 82.2% were American Society of Anesthesiologists (ASA) physical status I or II. There were no differences between groups concerning transfusions, operative time, Post-Anesthesia Care Unit (PACU) length of stay and in-hospital stay, and QoR-15 or postoperative pain. Bleeding measured by drain output at 2, 24 and 48 hours was significantly less in the TXA group at each timepoint. There was a difference in Hb variation - TXA: median (IQR) -1.4 (1.3) g.dL^-1 vs. NTXA: -2.2 (1.3) g.dL^-1; median difference: 0.80 (0.00-1.20); p = 0.047. aPTT was lower in TXA administered patients - TXA: median (IQR) 29.6 (14.0)s vs. NTXA: 33 (5.8)s; difference in medians: -4.00 (-6.50--1.00); p = 0.012.

Conclusion TXA use significantly decreased blood loss measured by drain output and Hb drop in TSA under regional anesthesia.

Keywords
Total shoulder replacement; Tranexamic acid; Surgical blood loss; Blood transfusion

	Total (n = 45)	TXA (n = 23)	NTXA (n = 22)	p-value
Age (years), mean ± SD	76.2 ± 6.4	76.7 ± 7.1	75.7 ± 5.7	0.602
Sex
Male, n (%)	7 (15.6)	4 (17.4)	3 (13.6)	1.000
BMI, mean ± SD	28.1 ± 4.0	28.0 ± 4.1	28.3 ± 4.1	0.784
ASA classification, n (%)				0.699
I-II	37 (82.2)	18 (78.3)	19 (86.4)
III	8 (17.8)	5 (21.7)	3 (13.6)
RCRI, n (%)				1.000
0	37 (82.2)	19 (82.6)	18 (81.8)
1-2	8 (17.8)	4 (17.4)	4 (18.2)
Hypertension, n (%)	31 (68.9)	18 (81.8)	13 (56.5)	0.108
Dyslipidemia, n (%)	23 (51.1)	9 (40.9)	14 (60.9)	0.181
Obesity, n (%)	7 (15.6)	2 (8.7)	5 (22.7)	0.243
Diabetes mellitus, n (%)	9 (20)	5 (21.7)	4 (18.2)	1.000
Chronic kidney disease, n (%)	3 (6.7)	2 (8.7)	1 (4.5)	1.000
Cerebrovascular disease, n (%)	3 (6.7)	1 (4.3)	2 (9.1)	0.608
Congestive heart disease, n (%)	1 (2.2)	0 (0)	1 (4.5)	0.489
Ischemic heart disease, n (%)	1 (2.2)	1 (4.3)	0 (0)	1.000
Chronic pulmonary disease, n (%)	3 (6.7)	0 (0)	3 (13.6)	0.109
Anemia, n (%)	15 (33.3)	11 (47.8)	4 (18.2)	0.057
Other hematologic disorders, n (%)	4 (8.9)	1 (4.3)	3 (13.6)	0.346
Hypothyroidism, n (%)	4 (8.9)	2 (8.7)	2 (9.1)	1.000
Depression, n (%)	4 (8.9)	1 (4.3)	3 (13.6)	0.346
Parkinson, n (%)	2 (4.4)	2 (8.7)	0 (0)	0.489

	TXA	NTXA	95% CI	p-value
Operative time (min), mean ± SD	113.7 ± 27.7	107.9 ± 35.2	-5.84 (-25.02-13.34)^a a 95% Confidence Interval of the mean difference.	0.542
Length of stay (days), median (IQR)	3 (1)	3 (2)	0.0 (-1.0-0.0)^b b 95% Confidence Interval of the median difference.	0.429
PACU length of stay (min), median (IQR)	127.5 (53.8)	120 (60)	0 (-20.0-45.0)^b b 95% Confidence Interval of the median difference.	0.752
QoR-15, mean ± SD	128.2 ± 22.3	121.4 ± 23.1	-6.78 (-21.48-7.93)^a a 95% Confidence Interval of the mean difference.	0.357
Numeric pain scale (0-10), median (IQR)
2 h
Rest	0	0
Motion	0	0
24 h
Rest	0 (3)	0 (1)	0.0 (0.0-0.0)^b b 95% Confidence Interval of the median difference.	0.296
Motion	2 (5)	0 (4)	2.0 (0.0-2.0)^b b 95% Confidence Interval of the median difference.	0.496
48 h
Rest	0 (0)	0 (0)	0.0 (0.0-0.0)^b b 95% Confidence Interval of the median difference.	0.180
Motion	0 (2)	0 (4)	0.0 (0.0-0.0)^b b 95% Confidence Interval of the median difference.	0.713
Inpatient pain breakthrough, n (%)	5 (25)	6 (28.6)	1.12 (0.52-2.42)^c c 95% Confidence Interval of the Odds Ratio.	1.000

	TXA	NTXA	95% CI	p-value
Drain output (mL), median (IQR)
2 h	45 (93)	100 (88))	-50.0 (-70.0-0.0)^b b 95% Confidence Interval of the median difference.	0.009
24 h	112.5 (108)	200 (100)	-60.0 (-110.0-20.0)^b b 95% Confidence Interval of the median difference.	0.008
48 h	150 (155)	210 (95)	-50.0 (-110-0.0)^b b 95% Confidence Interval of the median difference.	0.030
Hb (g.L^-1), mean ± SD
Preoperative	12.5 (1.5)	13.1 (1.3)	0.62 (-0.24-1.49)^b b 95% Confidence Interval of the median difference.	0.152
2 h	11.2 (1.9)	11.8 (1.5)	0.64 (-0.40-1.68)^a a 95% Confidence Interval of the mean difference.	0.220
24 h	10.8 (1.5)	10.8 (1.2)	0.004 (-0.810-0.817)^a a 95% Confidence Interval of the mean difference.	0.993
Hb variation, median (IQR)	-1.4 (1.3)	-2.2 (1.3)	0.80 (0.00-1.20)^b b 95% Confidence Interval of the median difference.	0.047
Hb loss (g), median (IQR)	54.2 (64.0)	91.7 (53.6)	-33.02 (-42.82-5.15)^b b 95% Confidence Interval of the median difference.	0.134
Total blood loss (mL), median (IQR)	458.1 (434.6)	672.3 (382.9)	-190.30 (-280.6-48.63)^b b 95% Confidence Interval of the median difference.	0.166
Need for transfusion, n (%)	3 (13.0)	2 (9.1)	1.50 (0.226-9.964)^c c 95% Confidence Interval of the Odds Ratio.	1.000
Platelets (×10⁹/L), median (IQR)	243.5 (118.0)	205.0 (74.0)	17.50 (-40.00- -42.00)^b b 95% Confidence Interval of the median difference.	0.982
aPTT (s), median (IQR)	29.6 (14.0)	33.0 (5.8)	-4.00 (-6.50- -1.00)^b b 95% Confidence Interval of the median difference.	0.012
INR, median (IQR)	0.99 (0.50)	1.02 (0.08)	-0.04 (-0.07-0.04)^b b 95% Confidence Interval of the median difference.	0.526

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Sociedade Brasileira de Anestesiologia (SBA) Rua Professor Alfredo Gomes, 36, Botafogo , CEP: 22251-080 , tel: +55 (21) 97977-0024 - Rio de Janeiro - RJ - Brazil
E-mail: editor.bjan@sbahq.org

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[1] PACU, Post-Anesthesia Care Unit; QoR, Quality of Recovery; IQR, Interquartil Range.

[TFN1] ^a
95% Confidence Interval of the mean difference.

[TFN2] ^b
95% Confidence Interval of the median difference.

[TFN3] ^c
95% Confidence Interval of the Odds Ratio.