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IRCT20200918048748N1 IRCT 2020-11-02 Kashan University of Medical Sciences Comparison of the effect of gabapentin and oral pregabalin on spinal anesthesia Comparison the effect of preoperative use of oral gabapentin and pregabalin on spinal anesthesia characteristics and side effects 2019-06-24 anticipated 72 Complete https://irct.ir/trial/51184 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study is done as permuted block randomization with hexagonal blocks of letters A, B and C and two of each (15 blocks), each of them will be labeled by codes 1 to 15 and then using the table of random numbers numbers 1 to 15 will be selected and finally a sequence of letters A, B and C will be created. The letters represent each of the study groups and after entering the study, patients receive one of the medications prescribed by the nurse. The drugs are prepared in the same containers and in the form of capsules with the same and uniform pustules. The person prescribing the medication is different from the person filling out the checklist. 2-3 Spinal anesthesia. Intervention 1: Intervention group: Group A with 300 mg of oral gabapentin made in Iran and Abidi Pharmaceutical Company, Patients receive this substance 2 hours before surgery. In sterile conditions after skin anesthesia with 2 CC lidocaine 2%, spinal anesthesia using cutting needle 25 and through the space between L5-L4 and L3-L4 vertebrae in The midline is performed with 15 mg of 0.5% hyperbaric bupivacaine for patients. Intervention 2: Intervention group: Group B, 150 mg Pregabalin made in Iran and Abidi Pharmaceutical Company, Patients receive this substance 2 hours before surgery. In sterile conditions after skin anesthesia with 2 CC lidocaine 2%, spinal anesthesia using cutting needle 25 and through the space between L4-L5 and L3-L4 vertebrae in The midline is performed with 15 mg of 0.5% hyperbaric Bupivacaine for patients. Intervention 3: Control group: Group C Oral placebo، Placebo capsule made in Iran and Abidi Pharmaceutical Company, Patients receive this substance 2 hours before surgery. In sterile conditions after skin anesthesia with 2 CC lidocaine 2%, spinal anesthesia using cutting needle 25 and through the space between L4-L5 and L3-L4 vertebrae in The midline is performed with 15 mg of 0.5% hyperbaric Bupivacaine for patients. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome, can be shared. When: Access period starts from 2020-2021 To whom: Researchers Conditions: For application or additional studies Where to obtain: Send mail to n.barzegar87@gmail.com How to obtain: Request in person or by e-mail Comments:
public Niloofar Barzegar
Kashan University of medical sciences-Qotbe Ravandi Blvd
Kashan Iran (Islamic Republic of) 8739118631 +98 31 5550 0111 n.barzegar87@gmail.com Kashan University of Medical Sciences scientific Seyed Mohammad Reza Razavizadeh
Sabaye dahom alley; Zanbagh alley; Golha alley; Kashan-Amir Kabir street
Kashan Iran (Islamic Republic of) 8739118631 +98 31 5554 0026 mr_razavzi48@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Being at the age of 18-70 years ASA class 1-2 undergoing orthopedic elective surgery with spinal anesthesia below the T10 level Duration of surgery less than 2 hours 18 years 70 years Both Weight less than 40 kg Hypersensitivity to pregabalin Hypersensitivity to the drug gabapentin Allergy to bupivacaine Localized sepsis at the injection site of the spinal needle Pregnancy and lactation O89.4 Spinal and epidural anesthesia-induced headache during the puerperium Treatment - Drugs Treatment - Drugs Placebo Intervention group: Group A with 300 mg of oral gabapentin made in Iran and Abidi Pharmaceutical Company, Patients receive this substance 2 hours before surgery. In sterile conditions after skin anesthesia with 2 CC lidocaine 2%, spinal anesthesia using cutting needle 25 and through the space between L5-L4 and L3-L4 vertebrae in The midline is performed with 15 mg of 0.5% hyperbaric bupivacaine for patients. Intervention group: Group B, 150 mg Pregabalin made in Iran and Abidi Pharmaceutical Company, Patients receive this substance 2 hours before surgery. In sterile conditions after skin anesthesia with 2 CC lidocaine 2%, spinal anesthesia using cutting needle 25 and through the space between L4-L5 and L3-L4 vertebrae in The midline is performed with 15 mg of 0.5% hyperbaric Bupivacaine for patients. Control group: Group C Oral placebo، Placebo capsule made in Iran and Abidi Pharmaceutical Company, Patients receive this substance 2 hours before surgery. In sterile conditions after skin anesthesia with 2 CC lidocaine 2%, spinal anesthesia using cutting needle 25 and through the space between L4-L5 and L3-L4 vertebrae in The midline is performed with 15 mg of 0.5% hyperbaric Bupivacaine for patients. Sensory block start time. Timepoint: It is measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours. Method of measurement: Based on the Visual Analogue Scale and recorded in the checklist. Duration of anesthesia. Timepoint: It is measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours. Method of measurement: Based on the Visual Analogue Scale and recorded in the checklist. Postoperative nausea and vomiting. Timepoint: They are measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours. Method of measurement: The incidence and severity of postoperative nausea and vomiting are assessed based on the simplified criterion of postoperative nausea and vomiting (PONV scale). Kashan University of Medical Sciences Approved 2019-12-01 Ethics Committee of Kashan University of Medical Sciences Kashan University of Medical Sciences; Parstar boulevard; Qutb Ravandi boulevard Kashan Isfehan Iran (Islamic Republic of)