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

Autor: E. N. Degovtsov, P. V. Kolyadko, V. P. Kolyadko, A. V. Satinov
Jazyk: ruština
Rok vydání: 2020
Předmět:
Zdroj: Неотложная медицинская помощь, Vol 8, Iss 4, Pp 430-436 (2020)
Druh dokumentu: article
ISSN: 2223-9022
2541-8017
DOI: 10.23934/2223-9022-2019-8-4-430-436
Popis: 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/m2 respectively (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
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