Effects Of Different Drug Delivery Strategies Of Tranexamic Acid On The Scores Of Hidden Blood Loss And Pain After Total Knee Arthroplasty

ObjectiveTo explore the effects of different doses of tranexamic acid(TXA)on the hidden blood loss、postoperative pain and the risk of postoperative complications after total knee arthroplasty(TKA).MethodsPatients undergoing elective TKA at the Affiliated Hospital of Qingdao University from June 2019 to October 2020 were enrolled in this trial.All eligible patients were randomly divided into four groups in a 1:1:1:1 ratio.Patients in the control group(A group,n=75)underwent TKA surgery only.Patients in TXA intracavity injection group(B group,n=75)were administrated with TXA using drainage tube after TKA surgery.Patients in single dose combination group(C group,n=75)were intravenously injection with a single dose of TXA 30 minutes before TKA surgery and received intracavitary injection after TKA surgery.Patients in double dose combination group(D group,n=75)were intravenously injection with a double dose of TXA 30 minutes before TKA surgery and 3 hours after surgery,and received intracavitary injection after TKA surgery.Before surgery,the baseline characteristics including gender,age,height,weight,body mass index(BMI),diseases history side to be replaced,hematocrit,the range of motion(ROM)of knee joint,thigh circumference at 10 cm above the patella,and visual analogue scale(VAS)scores were collected.The primary endpoint is the postoperative hidden blood loss.Secondary endpoints included VAS scores at 2,4 and 7 days postoperatively;ROM at 2,4,7 days and 1 month postoperatively;the change of thigh circumference at 2 and 4 days postoperatively;allogeneic erythrocyte infusion rate and infusion volume;the incidence rate of deep venous thrombosis(DVT)of lower extremities and pulmonary embolism(PE).Results1 Baseline characteristic data380 patients were screened out and 80 patients were excluded.Among them,56 patients did not meet the inclusion criteria and 24 patients refused to participate in the trial.Finally,233 patients were included in the analysis.There were 55 patients(mean age 65.51±6.97)in group A;59(mean age 66.05±5.93)in group B;61 in(mean age66.26±10.39)in group C;and 58(mean age 66.16±5.54)in group D.and there was no significant difference in baseline characteristic data,including weight,height,age,gender,BIM.In addition,the preoperative ROM of knee joint,high circumference at 10 cm above the iliac,and VAS scores were well-balanced among the four groups.2 The primary end pointFor the primary endpoint,the hidden blood loss of patients in group B,C,and D were 573.69±132.64 ml,517.39±102.25 ml,and 408.57±99.79 ml,respectively,which were all significantly lower than that of patients in group A 676.23±175.35 ml(P<0.05).The patients in group D had lowest level of hidden blood loss among four groups(P<0.05).3 Secondary end point3.1 With regards to VAS scores(when resting),the postoperative VAS scores at2,4and 7 days in groups B,C,and D were all obviously lower than that in group A.There were significant differences between group B,group C and group A,group D was lower than group B and C,and group D and group A were extremely significant difference(P<0.05).3.2 With regards to ROM,the results showed that the postoperative ROM at 2,4 and7 days in groups B,C,and D were all remarkably higher than that in group A.Especially,the ROM in group D was highest compared to other groups(P<0.05).Nevertheless,no statistical difference was found in the postoperative ROM at 1 month among four groups.3.3 In terms of the change of thigh circumference,we found that the change rates of thigh circumference at 10 cm above the iliac at 2 days postoperatively in four groups were6.83±0.11%,6.31±0.12%,5.88±0.12%,5.47±0.13%,and at 4 days were 6.49±0.14%,5.71±0.15%,5.63±0.15% and 5.01±0.14%,group D was lower than group B and C,and group D and group A were significant difference(P<0.05).3.4 The allogeneic erythrocyte infusion rate in in four groups were respectively30.90%,22.03%,16.39% and 9.43%,with statistical difference.Compared with group A,group C and group D had extremely significant differences.Among then,the allogeneic erythrocyte infusion rate of group D was lowest(P<0.05).3.5 According to the lower limb venous Doppler color Doppler ultrasound of the four groups of patients on the fourth day after surgery and the 3 months postoperative follow-up records,and combine the test results with symptoms and signs,no postoperative complication was found in all included patients.ConclusionTKA perioperative application TXA,especially double dose TXA,can not only reduce recessive bleeding,but also reduce postoperative limb swelling,relieve postoperative pain,and help patients recover knee function early after operation without increasing the risk of DVT and PE.