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IRCT20230128057251N1 IRCT 2023-05-29 Tehran University of Medical Sciences Clinical evaluation the effect of Xylapi ointment and lidocaine spray on the patient's satisfaction, stress, cooperation and pain level in spinal anesthesia for cesarean section and comparing it with the control group Clinical evaluation the effect of Xylapi ointment and lidocaine spray on the patient's satisfaction, stress, cooperation and pain level in spinal anesthesia for cesarean section and comparing it with the control group 2023-06-22 anticipated 258 Complete https://irct.ir/trial/68263 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We divide the patients into 3 groups by block randomization and quadruple block, totaling 86 people, which include 258 people and have a gestational age of more than 37 weeks. In the intervention group 1, which consists of 86 people, 10 grams of Xylapi ointment is used in a cross-sectional area of 10 square centimeters (according to the anesthesiologist's opinion) 20 to 30 minutes before the spinal injection in the place where the needle is inserted to create anesthesia. In the intervention group 2 as well 3 puffs of 10% lidocaine spray are used at the needle insertion site 5-10 minutes before the spinal. In the control group, 3 puffs of distilled water are used 10 minutes before the spinal, Blinding description: In this study, the subjects are aware that a new method is being studied and researched, but they are blinded to which group they belong to and which drug is being studied on them. 3 caesarean section. Intervention 1: In the intervention group 1, which consists of 86 people, 10 grams of Xylapi ointment is used in a cross-sectional area of 10 square centimeters (according to the opinion of an anesthesiologist) 20 to 30 minutes before the spinal injection at the place where the needle is inserted to create anesthesia. Then it is patched. The preb and lid are done and the mother is put under spinal anesthesia with a G25 needle and half percent marcaine ampoule. Intervention 2: In intervention group 2, 3 puffs of 10% lidocaine spray are used at the needle insertion site 5-10 minutes before the spinal injection. Intervention 3: In the control group, 3 puffs of distilled water are used 10 minutes before spinal. Yes - There is a plan to make this available What will be shared: This study aims to compare the effect of Xylapi ointment with lidocaine spray on reducing pain and anxiety during spinal surgery for cesarean section, and after collecting all the information related to the topics under study, it will be given to the researchers. When: After completing the data collection and writing the thesis in 1403 To whom: Specialists in obstetrics and gynecology and anesthesia Conditions: Persons who have access to the information by writing a letter to the research unit of Tehran University of Medical Sciences and the holder of the code of ethics and the IRCT code by referring to the research assistant of Baharlu Hospital. Where to obtain: Research Unit of Tehran University of Medical Sciences, Research Vice-Chancellor of Baharlu Hospital How to obtain: Writing a letter with the research unit of Tehran University of Medical Sciences and receiving the code of ethics and referring to the research unit of Baharlo Hospital and receiving information Comments:
public Zahra Ghale Noie
Behdari St., Rah Ahan Sq.
Tehran Iran (Islamic Republic of) 1339973111 +98 21 5565 8500 zgh.5068@gmail.com Tehran University of Medical Sciences scientific Zahra Ghale Noie
Behdari St., Rah Ahan Sq.
Tehran Iran (Islamic Republic of) 1339973111 +98 21 5565 8500 zgh.5068@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Pregnant women referred to Bharlo Hospital with a gestational age of more than 37 weeks who are candidates for elective cesarean section 15 years 50 years Female Gestational age below 37 weeks Pregnant women who are candidates for emergency cesarean section Pregnant women with chronic hypertension and diabetes History of allergy to lidocaine History of addiction and contraindications for spinal anesthesia Treatment - Drugs Treatment - Drugs Treatment - Drugs In the intervention group 1, which consists of 86 people, 10 grams of Xylapi ointment is used in a cross-sectional area of 10 square centimeters (according to the opinion of an anesthesiologist) 20 to 30 minutes before the spinal injection at the place where the needle is inserted to create anesthesia. Then it is patched. The preb and lid are done and the mother is put under spinal anesthesia with a G25 needle and half percent marcaine ampoule. In intervention group 2, 3 puffs of 10% lidocaine spray are used at the needle insertion site 5-10 minutes before the spinal injection. In the control group, 3 puffs of distilled water are used 10 minutes before spinal. The amount of mother's pain during spinal needle insertion. Timepoint: After caesarean section. Method of measurement: Visual Analog Scale. The level of mother's satisfaction during transfer to the ward (end of recovery). Timepoint: After caesarean section. Method of measurement: Visual Analog Scale. The level of mother's anxiety before the insertion of the spinal needle. Timepoint: After caesarean section. Method of measurement: Visual Analog Scale. The level of cooperation of the mother according to the anesthesiologist. Timepoint: After caesarean section. Method of measurement: Anesthesiologist grading from 1 to 10. Tehran University of Medical Sciences Approved 2023-01-23 Research Ethics Committees Of School Of Medicine Tehran University of Medical Sciences Research and Technology Affairs Management Unit, Room 604, 6th Floor, Headquarters of Tehran University of Medical Sciences, Corner of Qods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)