]>
IRCT20161126031095N3 IRCT 2023-06-21 Mazandaran University of Medical Sciences Comparison of the effect of adding Dexamethasone and Fentanyl to Bupivacaine in transverse abdominal plane block (TAP) on pain intensity after cesarean section by spinal anesthesia in Sari Emam hospital in 1401 Comparison of the effect of adding Dexamethasone and Fentanyl to Bupivacaine in transverse abdominal plane block (TAP) on pain intensity after cesarean section by spinal anesthesia in Sari Emam hospital in 1401 2023-06-22 anticipated 60 Complete https://irct.ir/trial/70549 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: There are different methods for random allocation in clinical trial studies, which is one of these methods, and in cases such as when the number in each group is to be selected in equal proportion, this method is appropriate. The size of each block is usually determined as a multiple of 4 or six or eight and so on. The size of all blocks can be considered as a fixed number or it can be considered variable based on the mentioned multiples. After selecting the eligible samples, in this study, randomization will be done by Block Randomization method. became. This process will be done with random allocation software. With the mentioned software, 10 blocks of six will be created. Samples will be assigned to each group based on randomly generated numbers, Blinding description: Before starting the study, the list of people will be randomly assigned to 2 study groups using a computer. Based on this list, envelopes are prepared, inside which the name of one of the treatment groups is written based on the list of random numbers. These envelopes will be provided to the first expert, and if the patients meet the entry criteria, an envelope will be opened for each patient and their treatment group will be determined based on it. The drug is prepared for injection by the mentioned expert and is handed over to the second expert (who does not know the type of drug) and finally the drug is given to the anesthesia assistant performing TAP Block. The completer of the checklist also has no knowledge of the drug group assigned to each patient. 2 Other acute postprocedural pain. Intervention 1: Intervention group: 50 micrograms of fentanyl plus 17 ml of 0.25% bupivacaine and 2 ml of 0.9% normal saline in a total volume of 20 ml on each side. Intervention 2: Intervention group: 4 mg of dexamethasone plus 17 ml of 0.25% bupivacaine and 2 ml of 0.9% normal saline in a total volume of 20 ml on each side. 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 further information".
public Alieh Zamani Kiasari
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3335 5080 aliehzamani@yahoo.com Mazandaran University of Medical Sciences scientific Alieh Zamani Kiasari
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3335 5080 aliehzamani@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients 18-50 years old Patients undergoing cesarean section under spinal anesthesia Patients with American Society of Anesthesiology (ASA) class I and II anesthesia status (ASA definition = healthy patient without organic, biochemical or mental disease and ASAII = patient with mild systemic disease such as mild asthma - controlled hypertension - disease has no effect on activity not daily - the possibility of affecting anesthesia and surgery) Patients who can perceive and evaluate their pain on a visual analog pain scale. (VAS; scale 0-10) They were eligible to provide written informed consent to enroll in the study Body mass index kg/m2 = 23.9-18.5 Absence of coagulopathy No alcohol or drug addiction 18 years 50 years Both Having chronic pain, or having underlying diseases such as moderate or severe heart, kidney, lung or nerve diseases, significant scoliosis or kyphosis, excessive obesity Taking painkillers before surgery Infection at the injection site History of abdominal surgery or trauma Respiratory tract infection within 2 weeks New York Heart Association Class >II cardiac status and psychiatric disorders that interfere with pain perception and evaluation They had a history of anaphylaxis using bupivacaine Patients who did not tolerate spinal anesthesia well and had to be converted to general anesthesia for cesarean section Individuals who could not provide informed consent or patients who did not wish to participate in the study G89.18 Other acute postprocedural pain Treatment - Drugs Treatment - Drugs Intervention group: 50 micrograms of fentanyl plus 17 ml of 0.25% bupivacaine and 2 ml of 0.9% normal saline in a total volume of 20 ml on each side Intervention group: 4 mg of dexamethasone plus 17 ml of 0.25% bupivacaine and 2 ml of 0.9% normal saline in a total volume of 20 ml on each side Postpartum pain intensity. Timepoint: 0/2/4/6/12 and 24/hours after the operation. Method of measurement: Visual Analogue Scale. Sedation. Timepoint: 0/2/4/6/12 and 24/hours after the operation. Method of measurement: Sedation criteria. Mazandaran University of Medical Sciences Approved 2023-03-13 Ethics Committee of Imam Khomeini Hospital of Sari - Mazandaran University of Medical Sciences Office Building Ethics Committee of Imam Khomeini Hospital Amir Mazandarani Blvd. Sari Mazandaran Iran (Islamic Republic of)