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IRCT20221122056579N1 IRCT 2022-12-04 Esfahan University of Medical Sciences Comparison the Effect of Adding Two Different Doses of Dexmedetomidine to Ropivacaine on Pain After Cesarean Section Comparison of Local Subcutaneous Infiltration with Ropivacaine Alone or Two Different Doses of Dexmedetomidine plus Ropivacaine for Postoperative Pain After Cesarean Section Under Spinal Anesthesia. 2023-01-21 anticipated 90 Complete https://irct.ir/trial/67027 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random division of eligible people into three groups is done using a table of random numbers. Tables of random numbers are prepared by computers that arrange numbers randomly. These tables have random numbers in both row and column directions, which usually reach 99 rows and columns, and the numbers of the rows and columns are in blocks of five digits next to each other and in a separated form to facilitate its use. To use the table of random numbers, the researcher must first find out the exact number of people in the society and give them a code in order. In this study, 90 people (total samples) should be divided into 3 groups of 30 people. Therefore, to each of the 90 people, two-digit codes such as 01, 02, 03, ..., 11, 12, .... 89, 90 is given. To select sample people from the table, the researcher randomly starts from a point of the table in the row or column direction. She can choose the point by closing his eyes and placing his finger or pen tip on the table. Movement in the direction of row or column does not differ and this work is related to the researcher's desire. But due to the two-digit codes, she must choose the same number of digits in the direction of the row or column. After this, numbers control the route. Willingly or not, she will come across two types of numbers, one of which is smaller than 90 and the other is larger than 90. She should pay attention and choose only the smaller numbers. The selected number is actually the code of an individual from the community that is selected as a sample. This work should continue until a small number can be selected for the number of sample people. After completing the sample volume, the first group is determined. To select the second group, after removing the people of the first group from the total of 90 people, this time she does the same thing considering 60 people and 30 people are selected from them. In this way, the remaining 60 people form the third group, Blinding description: Blinding method: the person who collects the data, the person who performs the statistical analysis, and the patients, do not know about the study groups. In order to comply with the conditions of blinding, the two drugs ropivacaine and the combination of ropivacaine and dexmedetomidine in two different doses of 1 and 2 mg/kg were prepared by the operating room nurse in similar syringes with the same size and labeled with three codes A, B, C before surgery. They will be placed and daily provided to an anesthetist and he will make the relevant prescription without knowing the type of intervention. In addition, the evaluator who is responsible for collecting information and the patient will not know the type of intervention in each group. The statistical analyst will not know the type of the two groups under study. In this way, the condition of being three-blind will be established. 3 Postoperative Pain after Cesarean Section, The effect of ropivacaine and dexmedetomidine drugs. Intervention 1: The first intervention group, In this group, at the end of the operation, before closing the wound, dexmedetomidine with a dose of 1 microgram/kg is injected into the patient in the form of subcutaneous infiltration with 0.5% ropivacaine at the rate of 3 mg/kg, which reaches a volume of 40 cc. Intervention 2: The second intervention group, In this group, at the end of the operation, before closing the wound, dexmedetomidine with a dose of 2 microgram/kg is injected into the patient in the form of subcutaneous infiltration with 0.5% ropivacaine at the rate of 3 mg/kg, which reaches a volume of 40 cc. Intervention 3: Control group, In this group, at the end of the operation, before closing the wound, ropivacaine 0.5% is injected to the patient at the rate of 3 mg/kg alone in a volume of 40 cc. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Atefeh Ghosouri
No. 18, Safabakhsh Alley, Rajaee St
Najafabad Iran (Islamic Republic of) 8513675711 +98 31 4263 3519 arefeh1377kabirzadeh@gmail.com Esfahan University of Medical Sciences scientific Atefeh Ghosouri
No. 18, Safabakhsh Alley, Rajaee St
Najafabad Iran (Islamic Republic of) 8513675711 +98 31 4263 3519 arefeh1377kabirzadeh@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for cesarean surgery (for the first time) Performing cesarean surgery under spinal anesthesia ASA I&II (American society of anesthesiologists) 15 years 55 years Female Patients with a History of Drug Allergy (Dexmedetomidine And Ropivacaine) Patients with a History of Tobacco and Opioid Addiction Patients with Psychological Problems Obese Patients Weighing More Than 100 kg Patients with Inability to Express Pain Score Suffering from Intracranial Hypertension Twin Pregnancy and Above Previous Abdominal and Pelvic Surgeries Uncontrollable Underlying Disease (ASA3 and higher) Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group, In this group, at the end of the operation, before closing the wound, dexmedetomidine with a dose of 1 microgram/kg is injected into the patient in the form of subcutaneous infiltration with 0.5% ropivacaine at the rate of 3 mg/kg, which reaches a volume of 40 cc. The second intervention group, In this group, at the end of the operation, before closing the wound, dexmedetomidine with a dose of 2 microgram/kg is injected into the patient in the form of subcutaneous infiltration with 0.5% ropivacaine at the rate of 3 mg/kg, which reaches a volume of 40 cc. Control group, In this group, at the end of the operation, before closing the wound, ropivacaine 0.5% is injected to the patient at the rate of 3 mg/kg alone in a volume of 40 cc. Pain after cesarean section based on Visual Analogue Scale. Timepoint: Pain at baseline (before spinal anesthesia) and then every 15 minutes during recovery and after that at 2, 4, 6, 12, 24 hours after surgery in the ward. Method of measurement: Visual Analogue Scale, It is evaluated based on a score from 0 (no pain) to 10 (severe pain). The amount of additional analgesic. Timepoint: If the patient's VAS is more than 4 cm, diclofenac sodium suppository 100 mg is used to relieve pain. Method of measurement: The number of diclofenac sodium suppositories 100 mg. The first time to receive analgesics. Timepoint: If the patient's VAS is more than 4 cm, diclofenac sodium suppository 100 mg is used to relieve pain. Method of measurement: Number of minutes after surgery. • The incidence of side effects include: nausea and vomiting, chills, hallucinations, hypotension (<30% of baseline), bradycardia (<60), hypertension and tachycardia (increase of more than 30% compared to baseline), Respiratory depression (< 10 times per minute). Timepoint: After recovery until discharge. Method of measurement: has/doesn't have. Patient satisfaction based on VAS. Timepoint: in hours 2, 4, 6, 12, 24 after entering the ward. Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2022-11-22 Research Ethics Committees of Isfahan University of Medical Sciences No. 18, Safabakhsh Alley, Rajaee St Najafabad Isfehan Iran (Islamic Republic of)