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IRCT20190227042862N1 IRCT 2019-05-23 Mashhad University of Medical Sciences The effect of intraperitoneal instillation of Lidocaine on the postoperative pain after cesarean delivery The effect of intraperitoneal instillation of Lidocaine on the postoperative pain after cesarean delivery 2018-11-22 anticipated 200 Complete https://irct.ir/trial/37902 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Pregnant women will be randomly assigned to one of the intervention or control groups by choosing one of the sealed envelopes (including the group name), Blinding description: Patients are unaware of receiving medication or placebo. Syringes containing the medication or placebo have the same appearance and are given to the surgeon as coded syringes. 3 Cesarean section. Intervention 1: Intervention group: After delivery of the neonate and placenta, and the surgeon satisfaction with hemostasis, a sterile 20-mL syringe containing 2% lidocaine with epinephrine 1:200,000 is given to the surgeon. Then she carefully instills the study drug on the uterine peritoneal area by spraying two third of the drug around the uterine spaces and one third in the incision location. Intervention 2: Control group: After delivery of the neonate and placenta, and the surgeon satisfaction with hemostasis, a sterile 20-mL syringe containing normal saline is given to the surgeon. Then she carefully instills the study drug on the uterine peritoneal area by spraying two third of the drug around the uterine spaces and one third in the incision location. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Razieh Hadi
16th ayatollah Bahjat ave.
Mashhad Iran (Islamic Republic of) 9144734767 +98 51 3278 2261 hadir931@mums.ac.ir Mashhad University of Medical Sciences scientific Razieh Hadi
16th ayatollah Bahjat ave.
Mashhad Iran (Islamic Republic of) 9144734767 +98 51 3278 2261 hadir931@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All pregnant women with singleton pregnancy between 18 to 45 years body mass index (BMI) less than 40 one previous cesarean section with pfannenstiel incision candidate for elective cesarean section with spinal anesthesia 18 years 45 years Female history of other abdominal surgery history of chronic pain history of cardiac arrhythmia Sensitivity to the drugs which are used in the intervention group O82.0 Single delivery by caesarean section Treatment - Drugs Placebo Intervention group: After delivery of the neonate and placenta, and the surgeon satisfaction with hemostasis, a sterile 20-mL syringe containing 2% lidocaine with epinephrine 1:200,000 is given to the surgeon. Then she carefully instills the study drug on the uterine peritoneal area by spraying two third of the drug around the uterine spaces and one third in the incision location. Control group: After delivery of the neonate and placenta, and the surgeon satisfaction with hemostasis, a sterile 20-mL syringe containing normal saline is given to the surgeon. Then she carefully instills the study drug on the uterine peritoneal area by spraying two third of the drug around the uterine spaces and one third in the incision location. Post-operative pain. Timepoint: 6, 12 and 24 hours after cesarean section. Method of measurement: Visual Analogue Scale. Mashhad University of Medical Sciences Approved 2018-11-26 Ethics committee of Mashhad University of Medical Sciences Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)