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IRCT20091117002723N2 IRCT 2023-02-07 Shiraz University of Medical Sciences Effects of two spinal anesthesia approaches in the Prevalence of headache after operation Comparison of post-dural puncture headache after paramedian approach versus Taylor's approach 2023-03-01 anticipated 370 Complete https://irct.ir/trial/68085 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be assigned randomly to tow groups using computer-generated random sequence numbers (www.randomization.org). Sealed envelopes will be used to conceal the allocation sequence. Group P will include patients who will undergo spinal anesthesia by a cutting 27-gauge spinal needle with a paramedian approach. Group T will include patients who will undergo spinal anesthesia by a cutting 27-gauge spinal needle with Taylor's approach, Blinding description: Participants in the study and those who follow up the participants do not know the method of spinal procedure and the specialist performs the spinal anesthesia based on the random sequence table. N/A Cesarean section. Intervention 1: Intervention group P: In the Paramedian approach, patients will be placed in the sitting position and a 27-gauge spinal needle is inserted into the subarachnoid space at an angle of 10-15 degrees in the spaces between L3-4 or L4-5, and then the cephalad is guided. Intervention 2: Intervention group T: Taylor's approach technique will be carried out at the L۵-S۱ inter space, the largest inter laminar inter space of the vertebral column. A spinal needle will be inserted in a cephalo-medial direction through a skin wheel raised ۱ cm medial and ۱ cm caudal to the lowermost prominence of the posterior iliac spine. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy.
public Mahsa Tahvili
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 tahvili_m@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) Women having elective caesarean section under spinal anesthesia Women between 18 and 44 years old Adult women with ASA grade I or II (American Society of Anesthesiology classification) 18 years 44 years Female Adult women with ASA grade III or IV (American Society of Anesthesiology classification) Patients with a history of more than 3 times cesarean section Pregnancy Induced Hypertension Hemodynamic instability Bleeding diathesis or coagulopathy Chronic headache Patients with local infection in the lumbar region O82 Encounter for cesarean delivery without indication Prevention Prevention Intervention group P: In the Paramedian approach, patients will be placed in the sitting position and a 27-gauge spinal needle is inserted into the subarachnoid space at an angle of 10-15 degrees in the spaces between L3-4 or L4-5, and then the cephalad is guided. Intervention group T: Taylor's approach technique will be carried out at the L۵-S۱ inter space, the largest inter laminar inter space of the vertebral column. A spinal needle will be inserted in a cephalo-medial direction through a skin wheel raised ۱ cm medial and ۱ cm caudal to the lowermost prominence of the posterior iliac spine. Headache. Timepoint: Up to 7 days after surgery. Method of measurement: Severity of Postdural puncture headache will be graded by a score described by Lybecker et al. Shiraz University of Medical Sciences Approved 2022-12-03 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)