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IRCT20221226056923N1 IRCT 2023-06-03 Shahid Beheshti University of Medical Sciences Analgesic effect of knee immobilizer and skin traction in pertrochantric fracture Comparison of the effects of knee immobilizer and skin traction in pain management of patients with peri-trochanteric fracture 2023-06-22 anticipated 75 Complete https://irct.ir/trial/67744 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into three groups using block randomization. For randomization, no stratification will be performed. For block randomization “R” version 3.6.3 (R Foundation for Statistical Computing, Vienna, Austria), RStudio, and "blockrand" package will be used (randomization tool will be statistical computer software). For allocation concealment, sealed opaque envelops will be used. N/A Pertrochanteric fracture of femur. Intervention 1: Intervention group 1: In the intervention group 1, patients will receive the study intervention, including the knee immobilizer during their hospitalization and before the operation. Knee immobilizer is a removable device that maintains the stability of the knee. In addition, patients will receive the standard protocol for the preoperative analgesia. The standard protocol will be IV acetaminophen (Apotel) 1 g every 12 h and IV morphine sulfate 5 g as needed. Intervention 2: Intervention group 2: In the intervention group 2, patients will receive the study intervention, including the skin traction during their hospitalization and before the operation. Traction is a directional pull on an extremity. In addition, patients will receive the standard protocol for the preoperative analgesia. The standard protocol will be IV acetaminophen (Apotel) 1 g every 12 h and IV morphine sulfate 5 g as needed. Intervention 3: Control group: Patients in the control group will only receive the standard protocol for preoperative analgesia without any additional intervention. The standard protocol will be IV acetaminophen (Apotel) 1 g every 12 h and IV morphine sulfate 5 g as needed. 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 Mohammad Ali Abdollahzadeh
Imam Hossein Hospital, Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 dr.mohammadali.abdollahzadeh@gmail.com Shahid Beheshti University of Medical Sciences scientific Farzad Amouzadeh Omrani
Imam Hossein Hospital, Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 f.amouzadeh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age between 40 and 70 patients with peri-trochantric fractures Patients who are neurologically oriented and aware of their pain 40 years 70 years Both Patients who have multiple trauma or those with fractures in other bones Obesity (BMI > 35) Patients with renal and/or hepatic disorders Patients who are diagnosed with Myasthenia Gravis, Dermatitis or have delusions Opium addict patients S72.1 Pertrochanteric fracture Treatment - Devices Treatment - Devices Treatment - Devices Intervention group 1: In the intervention group 1, patients will receive the study intervention, including the knee immobilizer during their hospitalization and before the operation. Knee immobilizer is a removable device that maintains the stability of the knee. In addition, patients will receive the standard protocol for the preoperative analgesia. The standard protocol will be IV acetaminophen (Apotel) 1 g every 12 h and IV morphine sulfate 5 g as needed. Intervention group 2: In the intervention group 2, patients will receive the study intervention, including the skin traction during their hospitalization and before the operation. Traction is a directional pull on an extremity. In addition, patients will receive the standard protocol for the preoperative analgesia. The standard protocol will be IV acetaminophen (Apotel) 1 g every 12 h and IV morphine sulfate 5 g as needed. Control group: Patients in the control group will only receive the standard protocol for preoperative analgesia without any additional intervention. The standard protocol will be IV acetaminophen (Apotel) 1 g every 12 h and IV morphine sulfate 5 g as needed. Visual analog scale (VAS) for pain at rest. Timepoint: 0, 12, AND 24 h after the hospitalization and daily afterward up to the time of operation. Method of measurement: Visual analog scale. Shahid Beheshti University of Medical Sciences Approved 2022-08-14 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor, Building Number 2, Shahid Beheshti University of Medical Sciences, Arabi Avenue, Daneshjoo Boulevard, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)