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IRCT20110306005993N3 IRCT 2021-11-14 Mazandaran University of Medical Sciences Comparsion of intraincisional bupivacaine, tramadol and bupivacaine plus tramadol in postoperative pain in elective cesarean section patients Comparsion of intraincisional bupivacaine, tramadol and bupivacaine plus tramadol in postoperative pain in elective cesarean section patients 2021-08-19 anticipated 90 Complete https://irct.ir/trial/56433 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients will be assigned to three groups through random blocking. A, B and C are 15 blocks of six randomly assigned blocking process and Random Allocation software is used. All 3 drugs are similar in appearance and volume and are responsible for preparing the mentioned drugs. Fill in syringes A, B and C and the anesthesia assistant injects the medicine into the patient according to the randomization block and random letters A, B and C without knowing the type of medicine. It is prepared in another room and delivered to the injector in the operating room, Blinding description: The drugs are prepared in a similar appearance and volume in another room and delivered to the injector in the operating room, where the patient injector and the evaluator are kept blind according to the type of treatment groups of the patients. 3 Cesarean section pain control. Intervention 1: Intervention group: The recipient of 100 mg of tramadol, which has reached a volume of 10 ml with normal saline, is finally injected by the surgeon at the incision site. Intervention 2: Intervention group: The recipient receives 10 mg of bupivacaine and 100 mg of tramadol, which has reached 10 ml of normal saline, at the end of the operation by the surgeon at the incision site. Intervention 3: Control group: Receiver of 10 mg of bupivacaine, which has reached a volume of 10 ml with normal saline, which is injected by the surgeon at the incision site at the end of the operation. 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 Doctor Seyed Abdollah Emadi
Amir Mazandarani Blvd. Imam Khomeini Hospital Anesthesiology Department
Sari Iran (Islamic Republic of) 33131 - 48166 +98 11 3336 1700 aemadi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Doctor Seyed Abdollah Emadi
Amir Mazandarani Blvd. Imam Khomeini Hospital Anesthesiology Department
Sari Iran (Islamic Republic of) 33131 - 48166 +98 11 3336 1700 aemadi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age between 15-45 years Have informed written consent to cooperate with the study Patient classification in class ASA1,2 15 years 45 years Female The patient refused to continue collaborating in this study Adequate spinal anesthesia and its conversion to general anesthesia Allergy to any of the drugs used History of addiction Existence of underlying pain such as back pain, headache History of using psychiatric drugs Get preoperative housing History of addiction O82.1 Delivery by emergency caesarean section Prevention Prevention Prevention Intervention group: The recipient of 100 mg of tramadol, which has reached a volume of 10 ml with normal saline, is finally injected by the surgeon at the incision site. Intervention group: The recipient receives 10 mg of bupivacaine and 100 mg of tramadol, which has reached 10 ml of normal saline, at the end of the operation by the surgeon at the incision site. Control group: Receiver of 10 mg of bupivacaine, which has reached a volume of 10 ml with normal saline, which is injected by the surgeon at the incision site at the end of the operation. The amount of pain. Timepoint: Intervals 6, 12 and 24 hours after surgery. Method of measurement: The Visual Analogue Scale (VAS) consists of a pain ruler that includes a horizontal line that is graded from zero to 10, with a 0-1 sign of pain 2-3 mild pain 4-6 moderate pain and 7 or more It is a sign of severe pain. In addition, it has various visual forms to determine the severity of pain. Nausea and vomiting. Timepoint: Intervals of 6, 12 and 24 hours. Method of measurement: Yes-no based on patient observations and statements. Mazandaran University of Medical Sciences Approved 2021-08-11 Imam Hospital of Sari - Research Ethics Committee of Mazandaran University of Medical Sciences Amir Mazandaran Blvd. Imam Khomeini Educational and Medical Center Sari Mazandaran Iran (Islamic Republic of)