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IRCT20200413047056N2 IRCT 2021-01-28 Birjand University of Medical Sciences Comparison of pethidine and bupivacaine in spinal anesthesia Comparison of the effect of intrathecal injection of pethidine, pethidine-bupivacaine and bupivacaine on pain severity and hemodynamic parameters after elective cesarean section 2021-01-31 anticipated 90 Complete https://irct.ir/trial/53865 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In this research, a simple randomization method will be used. In this way 90 sealed envelopes, each containing a card of a different color and each color representing a group, will be placed in a box. After entering the operating room, if the patient has the inclusion criteria, she will pull one envelope out of the box and will be placed in the desired group according to the color of the card inside, Blinding description: In this double-blind clinical study, 90 sealed envelopes, each containing a card of a different color and each color representing a group, will be placed in a box. After entering the operating room, if the patient has the inclusion criteria, she will pull one envelope out of the box and will be placed in the desired group according to the color of the card inside, and then the drug will be prepared by an independent researcher (anesthesia technician). 1-2 The rate of analgesia in cesarean section. Intervention 1: Intervention group 1: Healthy pregnant women 20 to 40 years old undergoing spinal anesthesia with pethidine. After prepping and draping, spinal anesthesia with 100mg of pethidine will be performed using a 25 G Quincke needle in the L4-L5 or L5-S1 intervertebral space in a sitting position. After the injection, the patient is immediately returned to the supine position, and standard monitoring including continuous pulse oximetry and ECG will be used. Intervention 2: Intervention group 2: Healthy pregnant women 20 to 40 years old undergoing spinal anesthesia with bupivacaine. After prepping and draping, spinal anesthesia with 10mg of bupivacaine will be performed using a 25 G Quincke needle in the L4-L5 or L5-S1 intervertebral space in a sitting position. After the injection, the patient is immediately returned to the supine position, and standard monitoring including continuous pulse oximetry and ECG will be used. Intervention 3: Intervention group 3: Healthy pregnant women 20 to 40 years old undergoing spinal anesthesia with the pethidine-bupivacaine mixture. After prepping and draping, spinal anesthesia with 50mg of pethidine and 5mg of bupivacaine will be performed using a 25 G Quincke needle in the L4-L5 or L5-S1 intervertebral space in a sitting position. After the injection, the patient is immediately returned to the supine position, and standard monitoring including continuous pulse oximetry and ECG will be used. Yes - There is a plan to make this available What will be shared: Total data after unidentifiable individuals When: One year after the results are published To whom: every one Conditions: For research Where to obtain: By Email with corresponding How to obtain: About a week Comments:
public Maliheh Zangoue
Ghaffari Ave
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3239 5000 Mzangoue@yahoo.com Birjand University of Medical Sciences scientific Amirs Saber Tanha
Ghaffari Ave
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3239 5000 amirsaber63@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) ASA 1 and ASA 2 (patients with healthy or controlled mild disease) in the range of 20 to 40 years No drug and smoking addiction No history of hypertension, diabetes and uncontrolled comorbidities Elective cesarean section No chronic pain No mental disorder and hysteria 20 years 40 years Female Emergency cesarean section Placental abruption Placental accreta Severe bleeding during surgery Drug and smoking addiction Uncontrolled comorbidities Take painkillers or antiemetics 24 hours before operation Skin infection at the site of lumbar injection History of bupivacaine or pethidine allergy Change ofanesthesia type during the operation Blood transfusion during the operation O74.6 Other complications of spinal and epidural anesthesia during labor and delivery Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Healthy pregnant women 20 to 40 years old undergoing spinal anesthesia with pethidine. After prepping and draping, spinal anesthesia with 100mg of pethidine will be performed using a 25 G Quincke needle in the L4-L5 or L5-S1 intervertebral space in a sitting position. After the injection, the patient is immediately returned to the supine position, and standard monitoring including continuous pulse oximetry and ECG will be used. Intervention group 2: Healthy pregnant women 20 to 40 years old undergoing spinal anesthesia with bupivacaine. After prepping and draping, spinal anesthesia with 10mg of bupivacaine will be performed using a 25 G Quincke needle in the L4-L5 or L5-S1 intervertebral space in a sitting position. After the injection, the patient is immediately returned to the supine position, and standard monitoring including continuous pulse oximetry and ECG will be used. Intervention group 3: Healthy pregnant women 20 to 40 years old undergoing spinal anesthesia with the pethidine-bupivacaine mixture. After prepping and draping, spinal anesthesia with 50mg of pethidine and 5mg of bupivacaine will be performed using a 25 G Quincke needle in the L4-L5 or L5-S1 intervertebral space in a sitting position. After the injection, the patient is immediately returned to the supine position, and standard monitoring including continuous pulse oximetry and ECG will be used. Pain. Timepoint: Within 24 hours after the intervention. Method of measurement: Number of suppositories consumed. Birjand University of Medical Sciences Approved 2019-07-23 Ethics committee of Birjand University of Medical Sciences Ghaffari Ave Birjand South Khorasan Iran (Islamic Republic of)