3.1. Study Population
This clinical trial was conducted after approval by the Ethics Committee of Hamadan University of Medical Sciences (IR.UMSHA.REC.1397.414 and IRCT 20120915010841N13) and obtaining written informed consent of patients in Fatemieh Hospital, Hamadan. Data collection tools included a researcher-made questionnaire in agreement with the research goals and variables. A convenience sampling method was used to form a sample of 106 patients (53 patients in each group). Patients were selected from among cesarean section candidates under spinal anesthesia who met the inclusion criteria. The inclusion criteria were 18-45-years-old, ASA class 1 or 2, not suffering from diabetes, hypertension, cardiac diseases, kidney diseases, eclampsia, pre-eclampsia, and spinal anesthesia contraindications (increased ICP, shock, coagulation problems, and anemia). The exclusion criteria were lack of consent to participate in the study, an emergency cesarean, multiple pregnancies, and failed spinal anesthesia.
3.2. Study Design
The sample size was calculated with a 0.05 alpha, 0.8 power, 34% P1, and 56% P2 (incidence of hypotension in spinal anesthesia in the sitting and lateral positions based on ref. No. 28). Finally, a total of 106 women were included in two groups, including 53 subjects in the sitting position (group S) and 53 subjects in the lateral position (group L). Patients were divided randomly into two groups. Randomization was carried out by block randomization using quadruple blocks. We choose a block at random, and the first four treatments were allocated according to the block. Then, a new block was chosen at random, and the next four treatments were allocated. We kept going until the required sample size was collected. To blind the study, an anesthesia resident performed spinal anesthesia in the sitting and lateral positions (according to randomization), and an anesthesiologist who was unaware of the randomization and classification of the groups collected information.
In all patients, 10 ml/kg Ringer solution was injected by a peripheral venous catheter no.18 after entering the operation room, and systolic and diastolic blood pressures, mean arterial pressure, heart rate, and initial SpO2 of patients were measured by a non-invasive monitoring system (Saadat, Novin S1800 model, Iran). Then, patients in groups S and L underwent spinal anesthesia with a 25 gauge Quincke needle (Mekon Medical Devices Co. Shanghai, China) at the L3-L4 space in the midline in the sitting and left lateral positions. After Cerebrospinal Fluid (CSF) aspiration, 10 mg hyperbaric bupivacaine 0.5% (2 mL, AstraZeneca, Austria) with 2.5 µg Sufentanil (Sufiject Aburaihan Co., Iran) was injected into the subarachnoid space, and immediately, the patient was placed in the supine position. Then, systolic and diastolic blood pressures, Mean Arterial Pressure (MAP), Heart Rate (HR), and SpO2 were recorded in both groups every two minutes until 10 minutes (minutes 2, 4, 6, 8, and 10), followed by every five minutes until 30 minutes (minutes 15, 20, 25, and 30) and every 10 minutes until 60 minutes (minutes 40, 50, and 60), by a nurse of anesthesia.
The sensory block was evaluated with a pinprick in each minute, and the time of beginning the sensory block (time to reach T6 sensory level) was recorded in the questionnaire. The quality of sensory-motor block in minutes 5 and 10 after spinal anesthesia, ephedrine and atropine doses, nausea and vomiting, and Apgar score of the newborn (minutes 1 and 5) were evaluated and recorded in the questionnaire. After the operation, the satisfaction of the patient was asked (in percent) and recorded. Hypotension was defined as systolic blood pressure lower than 90 mmHg, and 10 mg ephedrine was used to treat it. Bradycardia was defined as a heart rate lower than 60 per minute and treated with 0.5 mg atropine. The Bromage score was used to evaluate the quality of the motor block, and the following scale was used for the quality of sensory block: Painless: excellent, Mild tolerable pain: good, Moderate pain requiring sedatives: acceptable, and Severe pain requiring general anesthesia: poor. On the Bromage scale, 0 = the patient could raise the legs, 1 = the patient could flex the knees, 2 = the patient could move only toes, and 3 = the patient could not move the legs.
The classification of patients based on their physical condition was done according to the guidelines of the American Society of Anesthesiologists (ASA) from class 1 to class 6. A pinprick was used to determine the sensory block by a needle. The satisfaction of patients was determined based on 0 to 100 scores, as follows: < 80%: not satisfied, 80-90%: satisfied, and > 90%: very satisfied.