Epidural anaesthesia and myomectomy-associated blood loss: - a prospective randomised controlled study
Ginekologia polska. 2022
OBJECTIVES The management of anaesthesia for patients with large myomas is particularly important due to disruption of hemodynamic as a result of massive haemorrhage, the prolonged duration of surgery and requirement for additional interventions. This study evaluated the effect of anaesthetic technique on blood loss in patients undergoing myomectomy due to large fibroid uterus. MATERIAL AND METHODS A total of 156 patients that underwent myomectomy were randomized into two equal groups according to the type of anaesthesia: Epidural anaesthesia group and General anaesthesia group. The volume of blood loss and blood products transfusion was reviewed for each patient. RESULTS The intraoperative blood loss and need for blood transfusion were significantly higher in general anaesthesia group (p < 0.001). The mean hematocrit change was 2.5 ± 1.5 vs 3.7 ± 2.9 % (p = 0.001) for both groups. CONCLUSIONS In the myomectomy planning of women with a large fibroid uterus, the team of gynecologists and anaesthesiologists should take care to choose the most optimal technique for anaesthesia.
The safty profile of blood salvage applied for collected blood with amniotic fluid during cesarean section
BMC pregnancy and childbirth. 2022;22(1):160
BACKGROUND The guidelines of National Health Service(NHS, the United Kingdom) recommended for use in obstetrics at increased risk of bleeding, requiring two suction devices to reduce amniotic fluid contamination, however, when comes to massive hemorrhage, it is may difficult to operate because the complex operation may delay time. The aim of the study was to detect the effect of amniotic fluid recovery on intraoperative cell salvage in obstetrics and provide evidence for clinical applications. METHOD Thirty-four patients undergoing elective cesarean section were randomly divided into two groups. In group 1, the cumulative blood from the operation field, including the amniotic fluid, was collected using a single suction device for processing. In group 2, after suctioning away the amniotic fluid using another suction device for the cumulative blood from the operation field. From each group, four samples were taken, including maternal venous blood (sample I), blood before washing (sample II), blood after washing (sample III) and blood after filtration with a leukocyte filter (sample IV), to detect serum potassium (K +), hemoglobin (Hb), white blood cell (WBC), fetal hemoglobin (HbF), alpha fetoprotein (AFP) and squamous cell (SC) levels. RESULTS The AFP, K + and WBC levels of sample III and sample IV were significantly lower than sample I in group 1 and group 2 (P < 0.05). Significantly more SCs were found in sample III than in sample I in group 1 and group 2 (P < 0.05), but SCs of sample IV had no statistical difference compared to sample I in group 1 and group 2 (P > 0.05). There was no significant difference in the K + , Hb, WBC, AFP and SC levels of sample IV between group 1 and group 2 (P > 0.05). The HbF levels of sample III and sample IV were significantly higher in group 1 than in group 2 (P < 0.05). CONCLUSION There is little or no possibility for AF contamination to enter the re-infusion system when used in conjunction with a leucodepletion filter. For maternal with Rh-negative blood, we recommend two suction devices to reduce HbF pollution. TRIAL REGISTRATION ChiCTR1800015684 , 2018.4.15.
Effect of an "Autogenous Leukocyte Platelet-Rich Fibrin Tooth Graft" Combination around Immediately Placed Implants in Periodontally Compromised Sites: A Randomized Clinical Trial
International journal of dentistry. 2022;2022:4951455
OBJECTIVE Autogenous tooth bone graft (ATBG) was suggested as a source for bone grafting materials, especially as they have similar chemical composition to bone. This study goal was to assess the clinical and radiographic consequences of ATBG with or without L-PRF on bone deposition around immediate implants placed in periodontally hopeless sites. MATERIALS AND METHODS 26 patients, with periodontally diseased teeth, underwent random assignment to receive the surgical protocol either with L-PRF over ATBG around immediately inserted implants (test group) or without it (control group). Clinical examination was observed. Radiographically, bone changes horizontally and vertically to determine marginal bone loss (MBL) and mesiodistal bone changes were made at the base line and 6 and 9 months after implant insertion. Statistical analysis utilizing paired Student's t-test was used for comparing results within the same group, whereas an independent-sample t-test was used for intergroup variable comparison. RESULTS All implants met the criteria of success without any complications at the follow-up period. Nonsignificant differences were detected between horizontal bone alterations in both groups at 6 and 9 months (P > .001). The test group showed statistically significant lower MBL than the control group (P < .001). The mesiodistal bone gain in the test group was significantly higher than that of the control group at the 6-month period (P < .001). The mesiodistal bone loss in the control group was significantly higher than that of the test group at the 9-month period (P < .001). CONCLUSION The ATBG- L-PRF combination therapy enhances new bone formation and appeared to be a favorable procedure with immediate implant placement, particularly in severe periodontitis cases.
Two trade names of deferasirox (Osveral® and Exjade®) in reduction of iron overload parameters in major beta-thalassemia patients: A randomized open labeled clinical trial
Caspian journal of internal medicine. 2022;13(1):61-69
BACKGROUND Beta-thalassemia major patients typically require chronic transfusion and iron-chelating agents to reduce serum iron overload. Osveral(®) is an available Iranian brand name of deferasirox used by majority of thalassemic patients. The aim of this study was to compare the efficacy of Osveral(®) vs. Exjade(®) in major beta- thalassemia patients. METHODS In this randomized clinical trial, all patients received a single daily dose of 30 mg/kg either of Osveral(®) or Exjade(®) for 6 months. Primary outcome was the mean of bimonthly changes in serum ferritin concentration and secondary outcomes included mean changes of heart and liver MRI T2* after a year. RESULTS Finally, 80 patients completed the study. The mean serum ferritin level at the end of sixth month significantly decreased in Osveral(®) and Exjade(®) groups (p<0.01). After a year, means cardiac MRI T2* in Osveral(®) group were changed from 25.9±9.6 ms to 25.4±9.7 ms and in Exjade(®) group from 24.8±9.2 ms to 26.9±5.9 ms, with no significant difference (P=0.43). Mean liver MRI T2* for Osveral(®) and Exjade(®) groups were 8.6±6.4 ms (baseline 6.3±4.7) and 6.3±4 ms (baseline 4.9±3.5), respectively and there was no significant difference between two study arms (P=0.1). CONCLUSION Osveral(®) decreased significantly the serum ferritin level and improved heart and liver iron overload as efficient as Exjade(®). It can be a suitable cost-effective alternative agent in beta-thalassemia major patients.
Safety and efficacy of lidocaine plus epinephrine on intraoperative bleeding in abdominal myomectomy: A double-blind clinical trial
Health science reports. 2022;5(2):e551
BACKGROUND Uterine fibroid is a common benign pelvic tumor and abdominal myomectomy may cause excessive intraoperative bleeding, which may lead to adverse outcomes. OBJECTIVE This study was planned to evaluate the effectiveness of the injection of lidocaine plus epinephrine to reduce intraoperative bleeding in abdominal myomectomy. METHODS During October 2019 and May 2020, 60 eligible women with uterine fibroids were enrolled in a randomized controlled trial. Our patients were divided into two groups of lidocaine plus epinephrine defined as Group L and placebo defined as Group P. In group L, lidocaine 3 mg/kg plus 0.5 ml of adrenaline which reached to 50 cc with saline solution and in group P, 50 ml of normal saline was used. Both the combined solution and normal saline were infiltrated to the serous and myometrium above and around the fibroid before incision. Patients' demographic data, total operative time, hemoglobin changes, and the degree of surgical difficulty were evaluated and compared between the two groups. RESULTS There was no significant difference between the two groups in terms of demographic data. Hemoglobin changes (p < 0.0001) and the degree of surgery difficulty (p = 0.01) were significantly lower in Group L compared with Group P. In each group the drop in hemoglobin levels from baseline to 4 h postoperatively was significant (p < 0.0001). A significantly meaningful correlation was reported between hemoglobin changes and the degree of surgery difficulty with the size of the uterine and fibroids (p < 0.05). While a negative correlation was found regarding gravidity and surgery difficulty (r = -0.413, p = 0.02). Surgery duration was longer in Group P compared with Group L 70.66 ± 19.85 versus 66.16 ± 14.48, respectively, but with no significant difference (p = 0.32). No significant adverse reaction or serious complication was reported in the two groups. Hemodynamic parameters were kept in the normal range throughout the surgery. CONCLUSION A combination of lidocaine plus epinephrine during abdominal myomectomy appears to be a safe and effective method in reducing blood loss.
Can high-dose tranexamic acid have a role during transurethral resection of the prostate in large prostates? A randomised controlled trial
Arab journal of urology. 2022;20(1):24-29
OBJECTIVES To assess the efficacy and safety of high-dose tranexamic acid (TXA) during bipolar transurethral resection of the prostate (B-TURP) in patients with large prostates compared to placebo. PATIENTS AND METHODS From February 2018 to May 2020, 204 patients with enlarged prostates of 80-130 g and in need of surgical intervention were randomised into two groups. Patients in Group A underwent B-TURP and received TXA as an intravenous loading dose of 50 mg/kg over 20 min before induction of anaesthesia followed by a maintenance infusion of 5 mg/kg/h until resection was completed. The patients in Group B (placebo) received a saline infusion of a similar volume. RESULTS There was highly significant drop in haemoglobin in the placebo group at 4- and 24-h postoperatively compared with the TXA group (P < 0.001). However, there was no significant difference in the blood transfusion rate between the two groups with five patients (5.5%) in the placebo group and four (4.2%) in the TXA group requiring a transfusion (P = 0.74). The procedural time was significantly less in the TXA group vs the control group, at a mean (SD) of 79.93 (22.18) vs 90.91 (21.4) min (P = 0.001). Also, the intraoperative irrigation fluid volume and postoperative irrigation duration were significantly less in the TXA group vs the control group, at a mean (SD) of 19.21 (3.13) vs 23.05 (3.8) L and 14.75 (5.15) vs 18.33 (5.96) h, respectively (P = 0.001). Catheterisation and hospital stay durations were comparable between both groups (P = 0.384 and P = 0.388, respectively). No complications were recorded with use of high-dose TXA. CONCLUSION High-dose TXA was effective in controlling blood loss during B-TURP in patients with large prostates, with no adverse drug reactions.
Do liberal thresholds for red cell transfusion result in improved quality of life for patients undergoing intensive chemotherapy for acute myeloid leukemia? A randomized cross over feasibility study
Comparisons of Ultrasound-Guided Platelet-Rich Plasma Intra-Articular Injection and Extracorporeal Shock Wave Therapy in Treating ARCO I-III Symptomatic Non-Traumatic Femoral Head Necrosis: A Randomized Controlled Clinical Trial
Journal of pain research. 2022;15:341-354
BACKGROUND AND OBJECTIVE Osteonecrosis of the femoral head (ONFH) is a devastating disease, and there is some evidence that extracorporeal shock wave therapy (ESWT) and intra-articular platelet-rich plasma (PRP) injection might alleviate pain and improve joint function in individuals with ONFH. The objective of this study was to compare the effectiveness and safety of PRP and ESWT in symptomatic ONFH patients. METHODS A total of 60 patients aged 40-79 with unilateral ONFH at Association Research Circulation Osseous (ARCO) stages I, II, and III were randomly assigned to the PRP (N=30) or the ESWT group (N=30). Four treatment sessions were provided in both groups. Assessments were performed at baseline, and 1-, 3-, 6-, and 12-month. Primary outcomes were measured by the visual analogue scale (VAS), and pressure pain thresholds (PPTs). Secondary outcomes were assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Harris Hip Score (HHS), and magnetic resonance imaging (MRI). The linear mixed-model analysis was used to evaluate the differences between groups and within groups and the "group by time" interaction effects. RESULTS There were significant differences between groups in terms of changes over time for VAS, PPTs, WOMAC, and HHS since 3-month and maintained up to 12-month (P<0.05, except for PPTs at 12-month). The simple main effects showed that the patients in PRP group had greater improvements in VAS (mean difference = -0.82, 95% CI [-1.39, -0.25], P=0.005), WOMAC (mean difference = -4.19, 95% CI [-7.00, -1.37], P=0.004), and HHS (mean difference = 5.28, 95% CI [1.94, 8.62], P=0.002). No related adverse events were reported. CONCLUSION This study supported the effectiveness and safety of both the PRP injection and ESWT in treating ONFH patients. For symptomatic patients with ONFH, intra-articular PRP injection appeared superior to ESWT in pain relief and functional improvement.
Tranexamic acid for reducing blood loss following vaginal delivery: a double-blind randomized controlled trial
BMC pregnancy and childbirth. 2022;22(1):178
BACKGROUND Postpartum haemorrhage (PPH) is a major cause of maternal morbidity and mortality worldwide. Tranexamic acid (TXA) is a useful drug for prevention of PPH and merits evaluation in Nigeria, where PPH is the leading cause of maternal death (25%) and severe maternal morbidity. This study evaluates the efficacy of TXA in reducing blood loss following vaginal delivery. METHODS This was a double-blind randomized placebo-controlled study on the efficacy and safety of intravenous TXA in reducing blood loss in women undergoing vaginal delivery in a tertiary hospital. Data analysis was conducted with IBM SPSS software (version 20, Chicago II, USA). P-value < 0.05 was considered statistically significant. RESULTS The mean estimated blood loss was lower in TXA compared with the placebo group. (174.87 ± 119.83 ml versus 341.07 ± 67.97 ml respectively; P < 0.0001). PPH (blood loss > 500 ml) was 5.13% in the study arm compared to the control arm 7.14%- risk ratio (RR) 0.71; 95% CI: 0.38-1.79, p = 0.5956]. Additional uterotonics was required more in the control group compared to the treatment group 14(16.67%) versus 3(3.85%), p-value= 0.007. There were no major complications noticed in the treatment group. CONCLUSION This study demonstrated that intravenous administration of TXA reduced blood loss following vaginal delivery. It also reduced the need for additional uterotonics. However, blood loss greater than 500 was not significantly reduced. TRIAL REGISTRATION This trial was registered retrospectively. Pan African Clinical Trial Registry: PACTR202010828881019 on 12/10/2020.
Combined and intravenous administration of TXA reduces blood loss more than topical administration in primary total knee arthroplasty: A randomized clinical trial
Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia. 2022;166(1):68-76
AIM: To determine the most effective administration of tranexamic acid (TXA) in patients with primary total knee arthroplasty (TKA). MATERIAL AND METHOD We enrolled a total of 400 patients (154 men and 346 women) in this randomized trial (4 groups, each of 100 patients). The first group (IV1) had a single intravenous dose (15 mg TXA/kg) prior to skin incision. Group 2 (IV2) had TXA in 2 intravenous doses (15 mg TXA/kg): prior to skin incision and 6 hours after the first dose. Group 3 (TOP) had 2 g TXA in 50 mL of saline irrigated topically at the end of the surgery. The fourth group (COMB) combined IV1 and TOP regimens. We monitored the amount of total blood loss (TBL), haemoglobin drop, use of blood transfusions (BTs), and complications in each patient. RESULTS The amount of TBL was significantly lower in IV1, IV2 and COMB regimens compared to the TOP (P<0.0001). The lowest decrease in haemoglobin within 12 hours after surgery was observed in intravenous regimens (P=0.045). A significant difference in haemoglobin decrease on day 1 after the surgery was demonstrated in the COMB and intravenous regimens (P=0.011). CONCLUSION In primary TKA, it is preferable to administer TXA intravenously in two doses or in a combined regimen. Simple topical administration of TXA was not as effective and is indicated only in cases where systemic administration of TXA is contraindicated. No substantial complications occurred in either group of patients.