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IRCT20141009019470N91 IRCT 2019-12-18 Shiraz University of Medical Sciences Effects of general anesthesia versus spinal anesthesia for cesarean section on acute and chronic post operation pain Effects of general anesthesia versus spinal anesthesia for cesarean section on acute and chronic post operation pain 2020-01-21 anticipated 128 Complete https://irct.ir/trial/43346 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 128 full-term pregnant women undergoing elective cesarean section were randomly assigned to either the spinal (S) or general (G) groups (two groups of 64) using the Randomization.com extracted table, Blinding description: All patients were interviewed by an independent observer (unaware of anesthesia) at 2,4,8,12,18,24 hours postoperatively. 2-3 Cesarean delivery. Intervention 1: Intervention group:Pregnant women undergo elective cesarean section in group one under general anesthesia. Intervention 2: Intervention group: Pregnant women undergo elective cesarean section in group 2 undergo spinal anesthesia by 25G spinal needle puncture at the L3-L4 level by injection of 0.5% hyperbaric bupivacaine 10 mg into the intrathecal space. 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 Its against our policies.
public Masomeh Minoosepehr
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 asalmspr@gmail.com Shiraz University of Medical Sciences scientific Saied Khademi
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 khademish@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Full term pregnant mothers ASA1,2 Age over 18 years Elective cesarean section 18 years no limit Female More than two previous cesarean section Previous abdominal surgery Obese BMI> 35kg / m2 Chronic inflammatory diseases Alcohol consumption Psychiatric diseases History of chronic pain Diabetes Mellitus Preeclampsia and Eclampsia Coagulation Disorders Brain tumors Aspirin use in the last ten days Infection at the site of the block Intervertebral Disc Peripheral neuropathy P03.4 Newborn (suspected to be) affected by Cesarean delivery N/A N/A Intervention group:Pregnant women undergo elective cesarean section in group one under general anesthesia. Intervention group: Pregnant women undergo elective cesarean section in group 2 undergo spinal anesthesia by 25G spinal needle puncture at the L3-L4 level by injection of 0.5% hyperbaric bupivacaine 10 mg into the intrathecal space. Acute Pain. Timepoint: Post-operatively. Method of measurement: Visual Analogue Scale. Postoperative analgesic requirement -. Timepoint: In the Recovery Room. Method of measurement: Observasion. Shiraz University of Medical Sciences Approved Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of) Approved 2018-08-01 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)