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IRCT20210415050976N10 IRCT 2022-02-19 Jahrom University of Medical Sciences Comparison of the effect of adding pethidine to half-percent bupivacaine and half-percent ropivacaine on pain intensity in women undergoing elective cesarean section Comparison of the effect of adding pethidine to bupivacaine and half of ropivacaine on the severity of pain in women referred to Motahari Hospital during elective cesarean section. 2021-11-01 anticipated 60 Complete https://irct.ir/trial/58887 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used. With the help of the online site (www.sealedenvelope.com/simple-randomiser/v1/lists) randomization, 2 blocks of 30 are created. In each randomly assigned block, 30 patients are assigned to the bupivacaine group and 30 patients to the bupivacaine group, Blinding description: For blinding in the present study, the double-blind method is used, so that 1- the person who examines the results and 2- the person who performs the injections do not know which patient received ropivacaine or bupivacaine. 3 Cesarean section. Intervention 1: Intervention group: 12/5mg of bupivacaine as a local anesthetic made by Abu Reihan Pharmaceutical Company + 10 mg of pethidine as a narcotic made by Elixir Pharmaceutical Company Received intrathecally. Intervention 2: Intervention group 1: 15 mg of ropivacaine as a local anesthetic made by Abu Reihan Pharmaceutical Company + 10 mg of pethidine as a narcotic made by Elixir Pharmaceutical Company Received intrathecally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Navid Kalani
Jahrom, Shahid Motahari Boulevard
Jahrom Iran (Islamic Republic of) 7167758256 +98 71 2536 5231 k.navid@jums.ac.ir Jahrom University of Medical Sciences scientific Navid Kalani
Jahrom, Shahid Motahari Boulevard
Jahrom Iran (Islamic Republic of) 7167758256 +98 71 2536 5231 k.navid@jums.ac.ir Jahrom University of Medical Sciences Iran (Islamic Republic of) Hemodynamic stability Not having infection at the site of needle entry Not having High intracranial pressure Not having coagulation disorders 17 years 45 years Female History of addiction Allergy to drugs Obesity O75.82 Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section Treatment - Drugs Treatment - Drugs Intervention group: 12/5mg of bupivacaine as a local anesthetic made by Abu Reihan Pharmaceutical Company + 10 mg of pethidine as a narcotic made by Elixir Pharmaceutical Company Received intrathecally. Intervention group 1: 15 mg of ropivacaine as a local anesthetic made by Abu Reihan Pharmaceutical Company + 10 mg of pethidine as a narcotic made by Elixir Pharmaceutical Company Received intrathecally. Pain. Timepoint: When entering the operating room, when entering the recovery, leaving the recovery, 2 hours after the operation, 6 hours after the operation, 12 hours after the operation and 24 hours after the operation. Method of measurement: Visual scale of pain. Blood pressure changes. Timepoint: Before the operation, before the spinal, immediately after the spinal, after the baby is born and then every 10 minutes until the end of the operation, when entering the recovery, when leaving the recovery). Method of measurement: monitoring. Heart Rate. Timepoint: Before the operation, before the spinal, immediately after the spinal, after the baby is born and then every 10 minutes until the end of the operation, when entering the recovery, when leaving the recovery). Method of measurement: monitoring. Jahrom University of Medical Sciences Approved 2020-09-02 Ethics Committee of Jahrom University of Medical Sciences Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research Jahrom Fars Iran (Islamic Republic of)