]>
IRCT20230416057923N1 IRCT 2023-05-16 Tehran University of Medical Sciences Comparing the efficacy of Pregabalin with Duloxetine in perioperative pain management in knee fractures surgery Comparing the efficacy of Pregabalin with Duloxetine in perioperative pain management in knee fractures surgery: A randomized, double-blind, clinical trial 2023-06-22 anticipated 68 Complete https://irct.ir/trial/69617 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple block randomization: Patients will be divided into two groups by block randomization of 4 and 6 numbers. The random sequence will be created using the site https://www.sealedenvelope.com/simple-randomiser/v1/li. Concealment will also be done using The block randomization method is guaranteed. Packs of 8 capsules containing Duloxetine and Pregabalin, which are completely similar, are coded and provided to the researcher by a person who is not involved in the treatment, patient monitoring and analysis given in the study. The codes will be kept with this person until the end of the study, Blinding description: We will have two types of capsules A and B that are completely similar in terms of appearance, which are coded and prepared by someone other than the researchers and the patient, and he knows which type of capsule contains which of the study drugs, and the researcher who interviews the patients and the patients do not know which one Pregabalin or Duloxetine is prescribed for each patient. 2 Condition 1: perioperative pain in knee fractures surgery (patella). Condition 2: perioperative pain in knee fractures surgery (upper end of tibia). Condition 3: perioperative pain in knee fractures surgery (lower end of femur). Intervention 1: The first intervention group: a group of patients, from at least 24 hours before (at least two doses) until 48 hours after the operation, every 12 hours, an oral capsule containing 75 mg of Pregabalin (which is similar in appearance to the capsule of the other group) will do In addition, patients will similarly receive other analgesics according to hospital protocol. Intervention 2: The second intervention group: a group of patients, from at least 24 hours before (at least two doses) to 48 hours after the operation, every 12 hours, received an oral capsule containing 30 mg of Duloxetine (which is similar in appearance to the capsule of the other group). will do In addition, all patients will similarly receive other analgesics according to hospital protocol. 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 release schedule is not yet known
public Mohadeseh Masoumi
clinical pharmacy department, school of pharmacy 16th azar st.
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4709 Masoumimohadese@gmail.com Tehran University of Medical Sciences scientific Farhad Najmeddin
clinical pharmacy department, school of pharmacy 16th azar st.
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4709 f-najmeddin@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18 to 80 years Patients with fractures around the knee who are hospitalized and undergo surgery The patient is willing to participate in the study and sign the informed consent form. 18 years 80 years Both History of taking Duloxetine, Pregabalin and Gabapentin within two weeks before surgery History of allergy to study drugs Severe active infection leads to cognitive impairment Severe renal failure (MDRD renal clearance less than 30 ml/min/1.73m2) Severe liver failure (Child Pugh C or liver enzymes more than 5 times the maximum normal range) Moderate to severe dependence (according to DSM5 criteria) to opioids or use within 24 hours before entering the study BMI greater than or equal to 40 kg/m2 ASA Physical status IV/V Use of epidural anesthesia in surgery Pregnancy and breastfeeding NPO patients Active gastrointestinal ulcer high risk of bleeding before or after surgery Participate in another trial at the same time Concomitant use of SNRI, TCA, MAOI, st john wort within two weeks before entering the study Hemodynamic instability Being a communication barrier with the patient to evaluate him S82.0 S82.1 S72.4 Fracture of patella Fracture of upper end of tibia Fracture of lower end of femur Treatment - Drugs Treatment - Drugs The first intervention group: a group of patients, from at least 24 hours before (at least two doses) until 48 hours after the operation, every 12 hours, an oral capsule containing 75 mg of Pregabalin (which is similar in appearance to the capsule of the other group) will do In addition, patients will similarly receive other analgesics according to hospital protocol The second intervention group: a group of patients, from at least 24 hours before (at least two doses) to 48 hours after the operation, every 12 hours, received an oral capsule containing 30 mg of Duloxetine (which is similar in appearance to the capsule of the other group). will do In addition, all patients will similarly receive other analgesics according to hospital protocol. Pain intensity score. Timepoint: At the beginning of the study (before the start of the intervention), immediately before the operation and 6, 12, 24 and 48 hours after the operation. Method of measurement: Asking the patient with a numerical rating scale (NRS) (0 to 10). Cumulative dose of opioid consumption. Timepoint: 48 hours after the operation. Method of measurement: Record the cumulative amount of opioid consumed (using the patient file report) in the period from the beginning of the study to 48 hours after the operation. The time of the patient's first need for opioids. Timepoint: During 48 hours after the operation. Method of measurement: The time recorded in the patient's record report. Nausea or vomiting. Timepoint: At the beginning of the study (before the start of the intervention), immediately before the operation and then during the 48 hours after the operation. Method of measurement: Visiting and asking the patient. Hypoxia, Oxygen saturation (spo2) less than 89% on ambient air. Timepoint: At the beginning of the study (before the start of the intervention), immediately before the operation and then during the 48 hours after the operation. Method of measurement: View the Oxygen saturation (SpO2) values recorded in each visit from the patient's file. Bradycardia, Heart rate number less than 60 beats/min. Timepoint: At the beginning of the study (before the start of the intervention), immediately before the operation and then during the 48 hours after the operation. Method of measurement: Viewing the heart rate values recorded in each visit from the patient file. Hypotension, Systolic blood pressure less than 60.90 mmHg that causes symptoms in the patient. Timepoint: At the beginning of the study (before the start of the intervention), immediately before the operation and then during the 48 hours after the operation. Method of measurement: View blood pressure values recorded in each visit from the patient file. Occurrence or non-occurrence of delirium according to confusion assessment method for the ICU (CAM-ICU). Timepoint: At the beginning of the study (before the start of the intervention), immediately before the operation and then during the 48 hours after the operation. Method of measurement: confusion Assessment Method for the ICU (CAM-ICU) method in each visit. Tehran University of Medical Sciences Approved 2023-04-16 Institute of Pharmaceutical Sciences of Tehran University of Medical Sciences (Research Ethics Commi Faculty of Pharmacy, Tehran University of Medical Sciences, poorsina Ave Tehran Tehran Iran (Islamic Republic of)