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). Fracture of patella Fracture of upper end of tibia Fracture of lower end of femur
Conditions
Interventions
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
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohadeseh Masoumi
Tehran University of Medical Sciences
Outcome results
None listed