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IRCT20160403027191N5 IRCT 2023-10-29 Mazandaran University of Medical Sciences Comparison of ketorolac-induced analgesia with ketamine in lumbar fusion surgery patients using PCA pain pump Comparison of ketorolac-induced analgesia with ketamine in lumbar fusion surgery patients using PCA pain pump 2023-11-01 anticipated 120 Complete https://irct.ir/trial/71059 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the online system https://www.sealedenvelope.com/, patients will be randomly divided into three equal groups of 40 people based on the drugs used as follows: BACACB, CAACBB, CAACBB, CABBAC, .... For group A patients, ketamine and morphin; for group B Ketorolac and morphin and for group C only morphine will be given with a PCA pump, Blinding description: Before starting the study, the list of people will be randomly assigned to 3 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. The pumps will be marked with numbers 1, 2, and 3 and will be similar in terms of size and appearance, which only the nurse who will be involved in the project will be aware of, and other personnel and anesthesiologists will not be aware of the three studied groups. 3 Lumbar fusion. Intervention 1: Intervention group 1: Ketamine vial: Ketamine used in this study in group A, each milliliter of which contains 50 mg of ketamine (500mg/10ml) and is produced by STEROP-Belgium in Germany. Intervention 2: Intervention group 2: Ketorolac vial: Ketorolac used in this study in group B, each milliliter of which contains 30 mg of ketorolac and is produced by Caspian Tamin Company in Iran. Intervention 3: Intervention group 3: Group C: For group C patients, 20 mg of intravenous morphine, which has reached a volume of 100 cc with normal saline, will be given with a PCA pump. 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 Abdolmajid Gholi Nataj Jelodar
Mazandaran University of Medical Sciences, Valiasr Blvd.
Sari Iran (Islamic Republic of) 4815733971 +98 11 3325 5348 gholinataj54@mazums.ac.ir Mazandaran University of Medical Sciences scientific Abdolmajid Gholi Nataj Jelodar
Mazandaran University of Medical Sciences, Valiasr Blvd.
Sari Iran (Islamic Republic of) 4815733971 +98 11 3325 5348 gholinataj54@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) The patient's willingness to participate in the study and obtain informed consent Performing lumbar fusion surgery during the research Being 20 to 75 years old 20 years 75 years Both History of previous spine surgery Known hypersensitivity to ketamine or ketorolac Occurrence of any unusual complications during surgery Substance abuse and psychoactive drugs M43.26 Fusion of spine, lumbar region Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Ketamine vial: Ketamine used in this study in group A, each milliliter of which contains 50 mg of ketamine (500mg/10ml) and is produced by STEROP-Belgium in Germany. Intervention group 2: Ketorolac vial: Ketorolac used in this study in group B, each milliliter of which contains 30 mg of ketorolac and is produced by Caspian Tamin Company in Iran. Intervention group 3: Group C: For group C patients, 20 mg of intravenous morphine, which has reached a volume of 100 cc with normal saline, will be given with a PCA pump. Intensity of pain. Timepoint: at 2, 4, 6, 12, 18, 24 hours after surgery. Method of measurement: check list. Time of return from Ileus. Timepoint: At times 2, 4, 6, 12, 18, 24 hours after surgery. Method of measurement: check list. Nausea and vomiting. Timepoint: At times 2, 4, 6, 12, 18, 24 hours after surgery. Method of measurement: check list. Mazandaran University of Medical Sciences Approved 2023-06-07 Ethics Committee of Imam Khomeini Educational and Medical Hospital (RA) Sari - Mazandaran University Amir Mazandarani Blvd. Administrative Building of Ethics Committee of Imam Khomeini Hospital Sari Mazandaran Iran (Islamic Republic of)