الفهرس 
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Abstract
This prospective comparative study was conducted at Menoufia University Hospitals. The study protocol was approved by the Ethical Committee of the Faculty of Medicine, Menoufia University (IRB number: 3/2023 ANET H 45) and was registered at a public registry site available at ClinicalTrials.gov with a registration ID: NCT05931796. An informed written consent was obtained from all patients involved in the study. Fifty female patients were scheduled for modified radical mastectomy and randomly allocated into two equal groups using a computer program; the ERAS group and the non-ERAS group. Randomization was done by an independent person and randomized numbers were kept in an enclosed envelope to be opened at the operation time. The individuals collecting the intraoperative and postoperative data were blind to the study protocol.
The inclusion criteria were females, aged between 20 to 60 years, adequate cognitive state (able to understand and collaborate), and American Society of Anesthesiologists (ASA) physical status I and II.
The exclusion criteria were uncooperative patients, allergy to the study drugs, known abuse of alcohol or medication, local infection at the site of injection or systemic infection, pregnancy, coagulation disorders, and any complicated patients.
In the non-ERAS group, all patients received the best care practice, with standardization of preoperative and postoperative care.
Preoperatively, patients were admitted to the hospital on the day of surgery. Their medical history was obtained, and preparations were made by instructing them to refrain from consuming solid food for 6
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hours before the surgery. However, they were allowed to continue consuming clear fluids up to 2 hours before the surgery.
During the intraoperative period, standard monitoring procedures were implemented, which included Electrocardiography (ECG), Non-Invasive Blood Pressure (NIBP), and Pulse Oximetry. Following pre-oxygenation, general anesthesia was induced using fentanyl at a dose of 2 μg/kg, Propofol at a dose of 2 mg/kg, and atracurium at a dose of 0.5 mg/kg, and the muscle relaxation was monitored by a nerve stimulator.
The pressure-controlled volume guarantee ventilation mode was employed to maintain oxygen saturation above 98% and end-tidal carbon dioxide (ETCO2) levels around 30-35 mmHg. Anesthesia was sustained through the inhalation of 1.2 Minimum Alveolar Concentration of isoflurane and the depth of anesthesia was adjusted by using a Bi-spectral index monitor. If required, additional fentanyl intravenous boluses of 1-2 mcg/kg were administered for intraoperative analgesia. Intraoperative fluids were administered restrictively. Before surgical incision, a dose of one gram of cefotaxime was administered intravenously.
During the postoperative period, all patients were transferred to the recovery room and subsequently discharged to the general surgery ward once they met the recovery criteria. Pain management after surgery involved the administration of paracetamol, starting with one gram intravenous dose after 1 hour, followed by one gram every 8 hours.
Additionally, ketorolac, a nonsteroidal anti-inflammatory drug, was administered intravenously at a dose of 30 mg every 6 hours. However, if the VAS was equal to or greater than 4, nalbuphine was
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given at a dose of 0.25 mg/kg. Patients who experienced failed pain control, defined as a VAS score above 6, were excluded from the analysis. In the ERAS group, the ERAS pathway consists of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions.
Several interventions (e.g., preoperative optimization of comorbid conditions, avoidance of prolonged preoperative fasting and good hydration during the fasting period, intraoperative antibiotic prophylaxis, maintenance of normothermia, procedure-specific multimodal opioid-sparing analgesic regimen, nausea and vomiting prophylaxis, and venous thromboembolism prophylaxis) have become standard of care. Prevention of nausea and vomiting by ondansetron 4 mg IV postoperatively if the patient had more than 80 kg additional 4 mg was given.
In the ERAS group, Serratus Anterior Block was performed after induction of general anesthesia on the side of the operation. The patients were kept in the supine position, and the skin was prepared with an alcohol solution of 70%. A linear ultrasound transducer (SonoSite HFL 50_; SonoSite Inc., Bothell, WA, USA) was placed in a sterile cover. By using a perpendicular in-plane needle approach (anterior to posterior) and visualizing the needle tip at all times in the recommended superficial approach, the needle is advanced into the plane between the serratus anterior and latissimus dorsi with an injection of 20 ml 0.25% bupivacaine. Muscle layers should be seen to separate easily, with the fascial plane peeling open.
Visual analog score (VAS) was considered as a primary outcome and secondary outcomes were: heart rate, mean arterial blood pressure, length of hospital, anesthesia recovery time, intraoperative
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and postoperative opioid consumption, patient satisfaction score, and complications.
The following variables were measured:
Preoperative: Pre-operative demographic data such as age, and body mass index (BMI). Preoperative heart rate, mean arterial blood pressure, and oxygen saturation.
Intraoperative:
Heart rate every 10 min, mean arterial blood pressure (MAP) every 10 min, fentanyl consumption, isoflurane Minimum Alveolar Concentration (MAC), and surgical time.
Postoperative:
Hemodynamics (MAP‚ heart rate) were recorded 15 min after extubation, then after 2, 4‚6,12and 24 hours. Anesthesia recovery time. The visual analog score (VAS), was assessed 15 minutes after extubation then every hour for the first 8 hours, and subsequently every 3 hours for the remaining 24 hours. Patient satisfaction scores were as follows: grade 1 = very satisfied, grade 2 = satisfied, grade 3 = unsatisfied, and Grade 4 = very unsatisfied Postoperative opioid consumption, postoperative hospital stay time, and post-operative complications were recorded.
The current study revealed that both the non-ERAS pathway and ERAS care pathway achieved good pain control in all patients enrolled in our study but with a significant improvement of VAS in the ERAS care pathway group than in the non-ERAS pathway. The intraoperative and postoperative analgesic consumption was lower in the ERAS pathway with stable hemodynamics, shorter recovery time, and hospital stay.