]>
IRCT20091219002883N6 IRCT 2021-10-21 Mazandaran University of Medical Sciences Comparison of pain intensity and intrathecal complications of 50 and 100 μg morphine with very low dose of naloxone in patients undergoing cesarean section Comparison of pain intensity and intrathecal complications of 50 and 100 μg morphine with very low dose of naloxone in patients undergoing cesarean section 2021-10-17 anticipated 94 Complete https://irct.ir/trial/58670 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization In this method, a random sequence is first created using Snose software, Random Allocation version 2 software will be used for random arrangement of samples in blocks. In this software, we set the number of groups to 2, the number of samples to 47, the size of the blocks to be equal, and the coding to be a combination of letters, numbers, and random. Then, based on the sample size, read a number of envelopes with wrappers Aluminum (in order to obscure the contents of the envelopes), is prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. (Example: TF8G written on the envelope and the card inside the intervention envelope). Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants to the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed, Blinding description: The SNOSE method is used to hide (blind) random allocation. This method is one of the common methods in concealing random allocation. The researcher, assistant and anesthesiologist who is given a sample to inject, evaluate and analyze the data are kept blind in the study. 3 کنترل درد در جراحی سزارین. Intervention 1: 50 micrograms of intrathecal morphine with bupivacaine will be injected intravenously with 20 ng of naloxone after entering the operating room. Number of injections 1 time. Intervention 2: 100 micrograms of intrathecal morphine with bupivacaine will be injected intravenously with 20 ng of naloxone after entering the operating room. 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 Dr. Mohammadreza Habibi
Mazandaran Heart Center; fattemeh alzahra Hos. Sari
Sari Iran (Islamic Republic of) 48157-33971 +98 11 3332 3023 mohammadreza.habibi@gmail.com Mazandaran University of Medical Sciences scientific Muhammad faraji rad
Amir Mazandarani Blvd., Imam Khomeini Educational and Medical Center
Sari Iran (Islamic Republic of) 33131 - 48166 +98 11 3336 1700 m.farajirad@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Pregnant women with prior planning for cesarean section without Majo disease Absence of pregnancy-induced disease such as preeclampsia Term twin pregnancy (37 to 42 weeks) First or second pregnancy Tendency to cesarean delivery by spinal anesthesia 18 years no limit Female Dissatisfaction with participating in the study Any contraindications to anesthesia with spinal technique History of any idiocyncratic allergy or reaction to opioid drugs Chronic pain syndrome or regular use of opioids There is predictable evidence of anomaly in the fetus Allergy or intolerance to ketorolac, ibuprofen or oxycodone • Body mass index above 40 Failure of spinal anesthesia Prolongation of operation time G89.29 Other chronic pain Treatment - Drugs Treatment - Drugs 50 micrograms of intrathecal morphine with bupivacaine will be injected intravenously with 20 ng of naloxone after entering the operating room. Number of injections 1 time 100 micrograms of intrathecal morphine with bupivacaine will be injected intravenously with 20 ng of naloxone after entering the operating room. Reduce pain. Timepoint: The first 24 hours after cesarean section. Method of measurement: Visual Analogue Scale. The rate of nausea. Timepoint: Once every 6 hours for the first 24 hours after surgery. Method of measurement: questionnaire. Mazandaran University of Medical Sciences Approved 2021-09-15 Mazandaran University of Medical Sciences Amir Mazandarani Blvd. Imam Khomeini Educational and Medical Center Sari Mazandaran Iran (Islamic Republic of)