RESUMEN
BACKGROUND: Significant blood loss and requirement of allogenic blood transfusion during or after total knee replacement (TKR) have been reported. Incidence of blood transfusion in TKR is highly variable and depends on several factors. We investigated the blood utilization in patients undergoing TKR in our hospital and depicted the important risk factors that determine the need of allogenic blood transfusion in primary unilateral TKR. MATERIALS AND METHODS: The study included 1241 consecutive patients undergoing primary unilateral total knee arthroplasty. All the surgeries were performed by a single surgical team of orthopedists following standard procedure. Patient and disease details were obtained from patient file and hospital information system. Compatibility test was performed in blood bank before blood reservation following mandatory guidelines. Details of test, blood issue, and blood transfusion were documented in the blood bank. RESULTS: Of 1241 enrolled patients, 1069 (86.2%) were female. The median age of patients was 66 years with mean preoperative hemoglobin of 9.9 g/dL. Allogenic blood transfused was needed in 223 (17.9%) patients. Diabetes mellitus, hypertension, thyroid disorders, and chronic heart diseases were the major comorbid conditions. Risk factors such as gender, American Society of Anesthesiologists score, preoperative hemoglobin, and intraoperative and postoperative blood losses were significantly associated with blood transfusion. CONCLUSION: The risk factors determining blood transfusion in TKR vary between studies, however, all centers should establish standard operating procedures describing the surgical procedure and transfusion support in TKR. In addition, each center may develop specific blood management strategy to rationalize blood transfusion in TKR and overall successful care in TKR.
RESUMEN
OBJECTIVE: To assess the effectiveness, overall tolerability, and gastrointestinal (GI) tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg]) in symptomatic treatment of severe acute pain in physician's routine clinical practice. MATERIALS AND METHODS: In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18-60 years) with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at base-line, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. RESULTS: A total of 351 patients (mean age 44.2 years; male 43%; female 57%) were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (p<0.0001). The number of patients with severe intensity of pain reduced from 100% at baseline to 18.3% at day 2 and 6.96% at day 5. According to the patient assessment, 68.36% of patients reported tolerability as "very good to good", whereas according to physician's assessment, "very good to good" tolerability was reported in 68.27% of patients. Five (1.43 %) patients discontinued the study because of adverse drug reaction. Five patients developed nine GI-related events of moderate intensity. Two patients developed three adverse reactions (burning sensation in urine, giddiness, and urine retention) other than GI events. No serious adverse drug reactions were reported during the study period. CONCLUSION: Tramadol hydrochloride/diclofenac sodium is an effective and well-tolerated treatment in Indian patients with severe acute pain. Treatment with tramadol hydrochloride/diclofenac sodium provides significant pain relief on day 2 and maintained until day 5 without any serious adverse reactions.