Cesarean section.
Conditions
Interventions
Intervention 1: Intervention group: All participants are assessed and monitored for entry into the study and receive 500 ml of fluid volume (serum) as loading before the procedure. The patient is plac
Sponsors
The Varianphrmed Company
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Pregnant women between the ages of 18 and 40 Pregnant women undergoing cesarean section. Individuals with stable general health status according to ASA Class I or ASA Class II Body mass index (BMI) in the range of 18.5-30 People who are willing to participate in the study and are able to sign an informed consent form
Exclusion criteria
Exclusion criteria: Patients with serious and chronic heart, respiratory, or liver diseases, based on the researcher's opinion Patients with renal failure based on laboratory results of creatinine, BUN, and eGFR levels Patients with coagulation disorders or taking blood-thinning medications Diagnosed fetal or placental abnormality based on the investigator's opinion Patients with septicemia Patients with a history of shock People who have a history of serious side effects from spinal anesthesia or people who have contraindications to spinal anesthesia People with a history of allergy to bupivacaine or other local anesthetics Patients with a history of methemoglobinemia Women with hemoglobin less than 9 grams per deciliter Pregnant women with gestational hypertension or uncontrolled pregnancy-induced preeclampsia based on hypertension (systolic blood pressure = 140 mmHg and diastolic blood pressure = 90 mmHg) and proteinuria (= 300 mg of protein in 24-hour urine or protein-to-creatinine ratio in a random urine sample = 0.3) Patients with seizures or other neurological disorders, including neuropsychosomatic disorders and disorders related to brain and spinal cord injuries, based on the opinion of the researcher People who have had more than three previous cesarean sections. Multiple births at the time of study People with indications for emergency delivery History of drug or psychotropic substance abuse Infection at or around the injection site Gestational age less than 35 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (minutes) of onset of anesthesia/onset time of sensory blocks: onset of T4 dermatome block. Timepoint: At times 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 minutes after bupivacaine injection. Method of measurement: Using the Pinprick Test.;- Time (minutes) of onset of desired anesthetic effect for cesarean section: Beginning of T10 dermatome block. Timepoint: At times 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 minutes after bupivacaine injection. Method of measurement: Using the Pinprick Test.;Duration of anesthesia, sensory (minutes). Timepoint: At times 10, 20, 30, 40, 50, 60, 70, 80, 90, 110, 130, 150, 180 and 210 minutes after bupivacaine injection. Method of measurement: Based on the time interval between the onset of anesthesia and sensory regression L1.;Evaluation of motor block progression (the time to reach maximum motor block). Timepoint: At times 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 minutes after bupivacaine injection. Method of measurement: Reaching Bromage scale grade 3.;Duration of motor numbness (minutes). Timepoint: At times 10, 20, 30, 40, 50, 60, 70, 80, 90, 110, 130, 150, 180 and 210 minutes after bupivacaine injection. Method of measurement: The time interval between the onset of motor numbness and motor regression at Bromage level 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of pain intensity. Timepoint: At times 40, 50, 60, 70, 80, 90, 110, 130, 150, 180, 210 minutes and 4, 8, 12, 24, 36 and 48 hours after bupivacaine injection. Method of measurement: Using the Visual Analog Scale (VAS).;Assessing and recording the results of side effects monitoring. Timepoint: At times 0, 1, 2, 32, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 110, 130, 150, 180, 210 minutes and 4, 8, 12, 24, 36 and 48 hours after bupivacaine injection. Method of measurement: Blood pressure monitoring; cardiac arrhythmia; heart rate; local complications at the injection site; allergic reactions according to the physician's opinion; nausea and vomiting according to the patient's statements. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehdi Nazari Dehkordi
The Varianphrmed Company
Outcome results
None listed