Comparing the effects of using knee immobilizer and skin traction in pain management in patients with peritrochanteric fractures
Design
This study will be a three-arm, parallel-group, nonblinded, randomized, active-controlled trial.
Settings and conduct
A total of 75 patients with peritrochantric fracture in the orthopedic ward of the Imam Hossein will randomly be divided into three groups. Patients in the treatment groups will receive the study interventions, including knee immobilizer or skin traction, and in the control group will receive the standard analgesia protocol without any additional intervention. No blinding will be performed in this study.
Participants/Inclusion and exclusion criteria
Patients aged 40 to 70 who have peritrochanteric fractures and are aware of their pain level will be included in this study. Exclusion criteria are patients with multiple trauma or concurrent fractures and hepatic or renal dysfuntion.
Intervention groups
In this study, patients will be randomly divided into three groups, including skin traction, knee immobilizer, and control. The two intervention groups including the skin traction and knee immobilizer ones will receive the interventions during the preoperative course and patient hospitalization. The control group will receive no additional intervention for pain management except for the standard analgesia protocol.
Main outcome variables
The visual analog scale (VAS, 0-10) for pain at rest.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221226056923N1
Registration date:2023-06-03, 1402/03/13
Registration timing:prospective
Last update:2023-06-03, 1402/03/13
Update count:0
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Farzad Amouzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 3000
Email address
f.amouzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of knee immobilizer and skin traction in pain management of patients with peri-trochanteric fracture
Public title
Analgesic effect of knee immobilizer and skin traction in pertrochantric fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 and 70
patients with peri-trochantric fractures
Patients who are neurologically oriented and aware of their pain
Exclusion criteria:
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
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
7th Floor, Building Number 2, Shahid Beheshti University of Medical Sciences, Arabi Avenue, Daneshjoo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2022-08-14, 1401/05/23
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.337
Health conditions studied
1
Description of health condition studied
Pertrochanteric fracture of femur
ICD-10 code
S72.1
ICD-10 code description
Pertrochanteric fracture
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Devices
3
Description
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.