First Results of a Randomized Controlled Trial of Hemoblock in Patients with Large Incisional Hernias

Abstract

ABSTRACT. When penetrating into the cell, local anesthetics affect some structures and processes, in addition to blocking sodium channels, leading to the development of cell damage. The aim of the article was to study the damaging effect of bupivacaine on the sciatic nerve and biceps femoris in rats.AIM OF STUDY. Analysis of the first results of a randomized clinical trial (RCT) for the use of Hemoblock in patients with large incisional hernias and postoperative ultrasound (US) monitoring.OBJECTIVES. Improving the results of surgical treatment of patients with large incisional hernias.MATERIAL AND METHODS. Design of a simple blind randomized controlled trial with a 90 percent study power, α-error equal to 0.05 and β-error equal to 0.10. For this purpose, the total number of subjects is planned to be 66. Currently, there are 18 patients in the study, 10 in the comparison group (B), and 8 in the main group (A). Surgery is plastic prosthetic mesh implant in the sublay retromuscular position. We applied Hemoblock 15 ml retromuscularly and 15 ml subcutaneousely in group B. Wounds were drained by vacuum suction drains. Postoperatively — monitoring of a wounds by ultrasound examination on day 3, 7, 10, 12, 15, 18, and 21 after the removal of drains. The average age was 58.5±6.3 in group B and 55.6±11.7 years in group A (U=36.5, p>0.05), BMI 33.6±3.44 and 32.2±5.19 kg/m2respectively (U=35, p>0.05), the width of the hernia defect was 11±1.7 cm and 11.1±1.0 (U=33, р>0.05), length 13.6±2.7 cm and 12.5±3.3 cm (U=29.5, p>0.05), the area was 118±22.7 cm2 and 108.1±24.1 cm2 respectively (U=28.5, p>0.05). The average ASA was 2.2 in group B and 2.0 in group A.RESULTS AND DISCUSSION. Median of follow-up for all patients was 30 days. Significant differences obtained in the duration of postoperative wound drainage — 4.2±0.9 days in group B versus 2.5±0.5 days in group A (U=4, p<0.01). In patients of group A, the amount of discharge by drainage and the level of CRP and albumin were lower. On ultrasound examination of the postoperative wound, starting from the 10th day, a significantly smaller volume of fluid accumulations was revealed in patients of this group, and from the 15th day fluid accumulations were not detected. In group B, one patient had seroma IIIc (according to MoralesCondo, 2012), 8 patients had IVa seroma, and one patient had IVb seroma spontaneously opened through the postoperative wound, which required debridement of the cavity on an outpatient for 21 days. In group A, only 3 patients had IVa seroma. The number of punctures was 23 in group B, and 3 in group A (χ2=8.654, p=0.04, Fisher’s exact two-sided test (F) =0.00654, p<0.05). Hospital stay was 8.9±0.6 days in group B and 8.0±0.5 days in group A (U=11.5, p<0.05).CONCLUSION. According to preliminary data using local haemostatic agent Hemoblock allows: 1) to reduce the duration of postoperative wound drainage, 2) to reveal the period of inflammatory exudative processes in the postoperative wound, 3) to reduce the number of puncture interventions after incisional hernia repair, 4) to reduce the severity of pain and the need for analgesics, 5) to reduce the hospital stay time.Authors declare lack of the conflicts of interests.