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IRCT20220114053711N1 IRCT 2022-08-26 Mashhad University of Medical Sciences Effect of co-administration of oral pregabalin and intravenous ketorolac on post-operative pain in patients undergoing cesarean section with spinal anesthesia. Effect of co-administration of oral pregabalin and intravenous ketorolac on post-operative pain in patients undergoing cesarean section with spinal anesthesia. 2022-12-06 anticipated 56 Complete https://irct.ir/trial/61730 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling method is available and patients are divided into two groups of intervention (n = 28) and placebo (n = 28) based on random allocation method (with table of random numbers). The assigned codes are written separately on separate sheets and placed in separate envelopes or updated in such a way that the code written inside them is not available. After each patient with inclusion criteria is referred, an envelope is removed in order and according to the code written in it (for example a / b) the patient is placed in one of two groups. 3 cesarean section. Intervention 1: Intervention group: This group receives a 150 mg capsule of pregabalin one hour before the operation and a 30 mg dose of intravenous ketorolac during the operation after clamping the Tuff band. Intervention 2: Control group: The control group receives a placebo one hour before the operation. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts 6 months after the results are published. To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: The data can only be requested by academic and scientific researchers and after providing documentation indicating their employment and providing documentation indicating the reason for requesting the data. Where to obtain: Central Organization of Mashhad University of Medical Sciences, number: 051 38049 How to obtain: After the request from Mashhad University of Medical Sciences, the review will be done in about three months. Comments:
public Seyed Majid Taghizadeh Mayani
Mashhad Central Medical Sciences Building, University Street.
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3800 2000 taghizadehm3@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed Majid Taghizadeh Mayani
Mashhad Central Medical Sciences Building, University Street.
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3800 2000 taghizadehm3@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Pregnant mothers with I ASA and 18-40 years old who are candidates for elective cesarean section and spinal anesthesia, sign the informed consent form to participate in this project. Do not have a history of any neurological disease in the last three months. There are no contraindications to spinal surgery (hemodynamic abnormalities, coagulation defects, history of allergy to local anesthetics, lack of patient cooperation, and local infection). Do not have a history of taking calcium channel blockers and painkillers in the last three months. 18 years 40 years Female Need general anesthesia for any reason People with a contraindication for pregabalin use (a history of previous allergies to pregabalin or any of the ingredients in its formulation). Community Verified icon Treatment - Drugs Treatment - Drugs Intervention group: This group receives a 150 mg capsule of pregabalin one hour before the operation and a 30 mg dose of intravenous ketorolac during the operation after clamping the Tuff band. Control group: The control group receives a placebo one hour before the operation. Postoperative pain. Timepoint: at 6, 12, and 24 hours after surgery. Method of measurement: VAS (visual analog scale). Mashhad University of Medical Sciences Approved 2022-06-13 Ethics committee of Mashhad University of Medical Sciences Danesh and Salamat Shahrek, between Shahidjovan and Al Shahidi Square, Shaheed Fakuri Blvd, Mashhad, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)