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IRCT20091117002723N5 IRCT 2024-11-12 Shiraz University of Medical Sciences Comparison of Two Anesthesia Methods in Cesarean Section: Epidural and Spinal Comparison of single-shot epidural and spinal anesthesia in elective caesarean section in terms of hemodynamic changes and surgeon satisfaction. 2024-12-01 anticipated 80 Complete https://irct.ir/trial/79969 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 8 will be made for patients of two groups A & B. In each block, equal numbers for two groups will be considered in alternative positions. Then 10 blocks of size 8 will be selected randomly and patients will be allocated randomly and equally into two groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com, Blinding description: Before performing the anesthesia block, informed consent will be obtained from all patients, and they will be fully informed about the type of anesthesia to be used. In this study, an independent anesthesiologist, who is unaware of the randomization and type of anesthesia, will only assess and record the variables under investigation. This study is designed as a single-blind study to enhance the objectivity and accuracy of the results. 2-3 Cesarean section. Intervention 1: Control group: The first group, after the necessary preparations and pre-operative assessments, is positioned seated. Using a 27-gauge spinal needle and the median approach at the L3-L4 space, 10 mg of 5% Marcaine and 10 micrograms of fentanyl are injected into the cerebrospinal fluid. Subsequently, the patient is transferred to a supine position, and the sensory block level is evaluated using a blunt needle, targeting a desired level of T4 anesthesia. Intervention 2: Intervention group: In the second group, after positioning the patient in a seated position and completing the necessary preparations and pre-operative assessments, epidural anesthesia is performed using an 18-gauge Tuohy needle at the midline with the loss of resistance technique in the L3-L4 or L4-L5 space. Following the confirmation of entry into the epidural space, a test dose consisting of 3 cc of lidocaine and 15 micrograms of epinephrine is injected. If the epidural space is confirmed and no intravascular injection is detected, 16 cc of 0.5% Marcaine along with 100 micrograms of fentanyl is injected into the epidural space. The goal of this injection is to achieve the desired anesthesia level at T4. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is against our policy.
public Elnaz Rahimi
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 hasheminasabm@yahoo.com Shiraz University of Medical Sciences scientific Seyed Mohammad Reza Hadavi
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 hadavimr@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Adult women with ASA grade I (American Society of Anesthesiology classification) Women having elective caesarean section under spinal anesthesia Women between 18 and 44 years old 18 years 40 years Both Adult women with ASA grade II, III or IV (American Society of Anesthesiology classification) Emergency caesarean section Pregnancy Induced Hypertension Hemodynamic instability Multiple pregnancy History of drug use and addiction Fetal distress Eclamptic level of consciousness disorder (seizures, pulmonary edema, headache, visual disturbances) O82 Encounter for cesarean delivery without indication Treatment - Surgery Treatment - Surgery Control group: The first group, after the necessary preparations and pre-operative assessments, is positioned seated. Using a 27-gauge spinal needle and the median approach at the L3-L4 space, 10 mg of 5% Marcaine and 10 micrograms of fentanyl are injected into the cerebrospinal fluid. Subsequently, the patient is transferred to a supine position, and the sensory block level is evaluated using a blunt needle, targeting a desired level of T4 anesthesia. Intervention group: In the second group, after positioning the patient in a seated position and completing the necessary preparations and pre-operative assessments, epidural anesthesia is performed using an 18-gauge Tuohy needle at the midline with the loss of resistance technique in the L3-L4 or L4-L5 space. Following the confirmation of entry into the epidural space, a test dose consisting of 3 cc of lidocaine and 15 micrograms of epinephrine is injected. If the epidural space is confirmed and no intravascular injection is detected, 16 cc of 0.5% Marcaine along with 100 micrograms of fentanyl is injected into the epidural space. The goal of this injection is to achieve the desired anesthesia level at T4. Pain. Timepoint: During operation and at 2, 4, 6, 12, 24 hours after surgery. Method of measurement: Questionnaire and Numerical Pain Rating Scale (NRS). Consent of the surgeon. Timepoint: At the end of surgery. Method of measurement: Score 8-10: very high satisfaction, the surgeon is satisfied with all aspects of the operation.6-7 score: high satisfaction, the surgeon is satisfied with most aspects of the operation. Score 4-5: average satisfaction, the surgeon is satisfied with some aspects of the operation.2-3 score: low satisfaction, the surgeon is dissatisfied with some aspects of the operation.0-1 score: very low satisfaction, the surgeon is dissatisfied with most or all aspects of the procedure. Heart rate. Timepoint: Prior to the commencement of anesthesia, during the surgical procedure, and subsequently at 2, 4, 6, 12, and 24 hours following the completion of the surgery. Method of measurement: Monitoring. Blood Pressure. Timepoint: Prior to the commencement of anesthesia, during the surgical procedure, and subsequently at 2, 4, 6, 12, and 24 hours following the completion of the surgery. Method of measurement: Monitoring. Shiraz University of Medical Sciences Approved 2024-09-09 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)