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Peri-articular tranexamic acid injection in total knee arthroplasty: a randomized controlled trial.

ABSTRACT: Intravenous tranexamic acid (IV TXA) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (TKA) but its safety regarding venous thromboembolic events (VTEs) remains in question. The direct, local application of TXA may reduce systemic toxicity whilst maintaining good or better bleeding control compared to IV TXA. The topical application of TXA via Hemovac drains has been reported previously with good results. However, there are no data on peri-articular TXA injections during TKA.We conducted an open randomized, pilot study of peri-articular vs. IV TXA in 60 patients undergoing TKA. 30 patients received either: (i) 750 mg peri-articular TXA into the medial, lateral capsules and the quadriceps tendon prior to capsular closure and tourniquet deflation (group1), or (ii) 750 mg of IV TXA just before tourniquet deflation. Blood loss in the hemovac drain and hemoglobin (Hb) concentrations were measured at 24 and 48 h (h), and the number of blood transfusions and leg circumference measurements were recorded.At 48 h, the total blood loss in the hemovac drain was 445 mL in group 1 vs. 520 mL in group 2 (p?=?0.081) and the corresponding declines in Hb were 1.85 g/dL vs. 1.87 g/dL (p?=?0.84). 16 patients received blood transfusions: 9 vs. 7 in groups 1 and 2, respectively (p?=?0.928). There were no differences in thigh and lower leg circumferences, pain scores, knee flexion at discharge date and lengths of hospital stay. There were no clinically detected venous thromboembolic events.This pilot study has shown promising results for peri-articular TXA during TKA. Additional, larger studies are needed to confirm our results and be powered to show differences in efficacy and safety of peri-articular vs. IV TXA.ClinicalTrials.gov Identifier NCT02829346 . Retrospectively registered: 07/11/2016.

SUBMITTER: Pinsornsak P

PROVIDER: S-EPMC4960744 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Peri-articular tranexamic acid injection in total knee arthroplasty: a randomized controlled trial.

Pinsornsak P P Rojanavijitkul S S Chumchuen S S

BMC musculoskeletal disorders 20160726

<h4>Background</h4>Intravenous tranexamic acid (IV TXA) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (TKA) but its safety regarding venous thromboembolic events (VTEs) remains in question. The direct, local application of TXA may reduce systemic toxicity whilst maintaining good or better bleeding control compared to IV TXA. The topical application of TXA via Hemovac drains has been reported previously with good results. However, there are n ...[more]

PMID: 27455842

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Project description:BackgroundAs an essential component of multimodal analgesia approaches after total knee arthroplasty (TKA), local infiltration analgesia (LIA) can be classified into peri-articular injection (PAI) and intra-articular injection (IAI) according to administration techniques. Currently, there is no definite answer to the optimal choice between the two techniques. Our study aims to investigate analgesic efficacy and safety of PAI versus IAI in patients receiving simultaneous bilateral TKA.MethodsThis randomized controlled trial was conducted from February 2017 and finished in July 2018. Sixty patients eligible for simultaneous bilateral total knee arthroplasty were randomly assigned to receive PAI on one side and IAI on another. Primary outcomes included numerical rating scale (NRS) pain score at rest or during activity at 3?h, 6?h, 12?h, 24?h, 48?h, and 72?h following surgery. Secondary outcomes contained active or passive range of motion (ROM) at 1, 2, and 3?days after surgery, time to perform straight leg raise, wound drainage, operation time, and wound complications.ResultsPatients experienced lower NRS pain scores of the knee receiving PAI compared with that with PAI during the first 48?h after surgery. The largest difference of NRS pain score at rest occurred at 48?h (PAI: 0.68, 95%CI[0.37, 0.98]; IAI: 2.63, 95%CI [2.16, 3.09]; P <?0.001); and the largest difference of NRS pain score during activity also took place at 48?h (PAI: 2.46, 95%CI [2.07, 2.85]; IAI: 3.90, 95%CI [3.27, 4.52]; P =?0.001). PAI group had better results of range of motion and time to perform straight leg raise when compared with IAI group. There were no differences in operation time, wound drainage, and wound complication.ConclusionPAI had the superior performance of pain relief and improvement of range of motion to IAI. Therefore, the administration technique of peri-articular injection is recommended when performing local infiltration analgesia after total knee arthroplasty.Trial registrationThe trial was retrospectively registered in the Chinese Clinical Trial Registry as ChiCTR1800020420 on 29th December, 2018.Level of evidenceTherapeutic Level I.

Project description:BackgroundA combined intravenous and intra-articular regimen is one of the most effective administration routes of tranexamic acid (TXA) to reduce perioperative blood loss in unilateral total knee arthroplasty. However, there have been few reports regarding use of the combined regimen for patients undergoing simultaneous bilateral total knee arthroplasty, in which blood-management strategy is more challenging.MethodsWe compared perioperative blood loss in 30 consecutive patients undergoing simultaneous bilateral total knee arthroplasty who received both 1,000 mg of TXA intravenously and 1,000 mg of intra-articular TXA in each knee (combined TXA group) with that in a consecutive series of 51 patients who only received 1,000 mg of TXA intravenously (intravenous TXA group). Additional intravenous TXA was administered 6 hours after the initial administration in both groups. Except for the intraoperative TXA administration regimen, an identical perioperative blood-management strategy was applied to both groups; this consisted of transfusion of 800 or 400 mL of predeposited autologous blood except for patients with a preoperative hemoglobin level of <11.0 g/dL, who received 4 units of allogenic blood. All surgical procedures were performed with spinal anesthesia and without use of a pneumatic tourniquet. Perioperative blood loss was calculated using the blood volume and change in hemoglobin level from the preoperative measurement to postoperative day 3.ResultsThere was significantly less perioperative blood loss in the combined TXA group compared with the intravenous TXA group (mean and standard deviation, 1,201 ± 347 versus 1,638 ± 400 mL, respectively; mean difference, 437 mL; 95% confidence interval, 263 to 613 mL; p < 0.0001). No patient in the combined TXA group and 1 patient (2%) in the intravenous TXA group required additional allogenic blood transfusion. No thrombotic events occurred in either group.ConclusionsIn a nonrandomized comparison, combined intra-articular and intravenous TXA significantly reduced the calculated perioperative blood loss in simultaneous bilateral total knee arthroplasty compared with that found in patients treated only with intravenous TXA.Level of evidenceTherapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Project description:BackgroundThis study aimed to assess the efficacy of tranexamic acid (TXA) mixed in a periarticular multimodal cocktail (PAMC) as a topical administration and to determine whether combined use of intravenous and topical administration is more effective than a single administration of TXA.MethodsA total of 240 patients who underwent primary total knee arthroplasty (TKA) was enrolled for this prospective randomized controlled study. Patients were divided into three groups of 80 patients each. Baseline data were comparable for all groups. Average follow-up was 18.7 months. Group 1 consisted of patients who received intravenous (IV) TXA, Group 2 patients were those who received TXA in a PAMC injection for topical administration, and Group 3 consisted of patients who received a combination of both intravenous and topical administration of TXA. Primary outcomes were postoperative hemoglobin drop and amount of suction drainage. Secondary outcomes were estimated blood loss (EBL), postoperative transfusion rate, and complications.ResultsThe mean postoperative hemoglobin drop was significantly lower in Group 3 (2.13 ± 0.77 g/dL, p=0.004), and there was no difference between Group 1 and Group 2 (2.56 ± 1.07 g/dL vs 2.55 ± 0.86 g/dL, p=0.999). The mean drainage amount was significantly lower in Group 3 (326.58 ± 57.55 ml, p<0.001), and there was no difference between Group 1 and Group 2 (367.93 ± 87.26 ml vs 397.66 ± 104.10 ml, p=0.072). Similarly, the mean EBL was significantly lower in Group 3 (p=0.003), and there was no significant difference between Group 1 and Group 2 (p=0.992). There were no significant differences in requirement for postoperative transfusion rate or incidence of complications among the three groups.ConclusionTXA mixed in a PAMC injection showed a similar effect to IV administration of TXA following TKA. Furthermore, combined use of both IV and PAMC injection provided better perioperative bleeding control with similar safety in patients without relevant comorbidities.Trial registrationWHO ICTRP identifier KCT0005703 . Retrospectively registered: 12/24/2020.

Project description:Total knee arthroplasty (TKA) is associated with a significant blood loss. Several methods have been reported to reduce postoperative blood loss and avoid homologous blood transfusions. In this study, we investigated the efficacy of temporary clamping of the drain either or not in combination with tranexamic acid administration for controlling blood loss after TKA.The prospective, randomized, and double-blinded study was conducted in our institute. Total of 240 patients, who diagnosed primary osteoarthritis and scheduled to undergo a primary TKA,,were randomized into one of the four groups: Group A or control group, the drain was not clamped and the patient received a placebo; Group B, the drain was not clamped and the patient received tranexamic acid; Group C, the drain was clamped and the patient received a placebo; and Group D, the drain was clamped and the patient received tranexamic acid. The volume of drained blood at 48 hours postoperatively, the decreasing of hemoglobin (Hb) level at 12 hours postoperatively and the number of patients requiring blood transfusion were recorded and compared.The mean postoperative volumes of drained blood and the amount of blood transfusion in the three study groups (group B, C and D) were significantly lower than those in the control group (p?<?0.05), which group D had the lowest values. Furthermore, group B and D could maintain the Hb level better than group A and C (p?<?0.001). In terms of blood transfusions rate, although the patients in group D required transfusion less than group A and C (p?<?0.05), there was no significant difference between group D and B. The relative risks for transfusion requirement were 4.4 for group A, 1.4 for group B and 3.0 for group C when compared to group D.The clamping of drain combined with tranexamic acid administration could reduce postoperative blood loss and blood transfusion after TKA, significantly greater than using tranexamic acid or drain clamping alone.ClinicalTrials.gov NCT01449552.

Dataset Information

Peri-articular tranexamic acid injection in total knee arthroplasty: a randomized controlled trial.

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Peri-articular tranexamic acid injection in total knee arthroplasty: a randomized controlled trial.

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