An investigation into the analgesic effects of Apotel and transcutaneous electrical nerve stimulation on post-operative pain management of patients with knee replacement
An investigation into the analgesic effects of Apotel and transcutaneous electrical nerve stimulation on post-operative pain management of patients with knee replacement
Design
This study is clinical trial and double blind. patients will be divided in 2 groups by simple randomization.Groups are parallel.
Settings and conduct
Patients candidate knee joint replacement in Valiasr hospital in Arak will enter this study. This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria:People aged 20 to 80 with normal preoperative mobility
Exclusion criteria:Patients with neuropathic pain or sensory impairment in the case of surgery, history of previous knee surgery, sensitivity to medications, body mass index more than 40 , no underlying disease
Intervention groups
Intervention group:In the TENS group, 4 pads are placed on each side of the waist around L1 to T10 for half an hour 1, 6, and 12 hours after surgery. Pad sizes are 40 x 100.To study the frequency of the device is set to 100 Hz.
The device is for Body Clock Health Care London.With an output of 0 to 110 mA, which is represented by Tasmanim Arman Behbod Company in Iran.
control group:In the Apotel group, one gram in 10 ml of normal saline was given in recovery and continued for 24 hours postoperatively.
Main outcome variables
Pain, mean heart rate, mean blood pressure, oxygen saturation percent, opioid intake in 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N127
Registration date:2019-12-26, 1398/10/05
Registration timing:registered_while_recruiting
Last update:2019-12-26, 1398/10/05
Update count:0
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An investigation into the analgesic effects of Apotel and transcutaneous electrical nerve stimulation on post-operative pain management of patients with knee replacement
Public title
An investigation into the analgesic effects of Apotel and transcutaneous electrical nerve stimulation on post-operative pain management of patients with knee replacement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 20 to 80 with normal preoperative mobility
Exclusion criteria:
Patients with neuropathic pain or sensory impairment in the case of surgery
History of previous knee surgery
Sensitivity to medications
Body mass index more than 40
No underlying disease
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.ARAKMU.REC.1397.150
Health conditions studied
1
Description of health condition studied
Knee joint replacement
ICD-10 code
M23.9
ICD-10 code description
Internal derangement of knee, unspecified
Primary outcomes
1
Description
Pain
Timepoint
At recovery time, 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Visual analogue pain questionnaire
2
Description
Amount of narcotic drug used
Timepoint
During 24 hours after surgery
Method of measurement
milligram
3
Description
Mean arterial blood pressure
Timepoint
First and in recovery
Method of measurement
Barometer
4
Description
Mean heart rate
Timepoint
First and in recovery
Method of measurement
Count
5
Description
Oxygen saturation percentage
Timepoint
First and in recovery
Method of measurement
Pulse Oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the TENS group, 4 pads are placed on each side of the waist around L1 to T10 for half an hour 1, 6, and 12 hours after surgery. Pad sizes are 40 x 100.To study the frequency of the device is set to 100 Hz. The device is for Body Clock Health Care London.With an output of 0 to 110 mA, which is represented by Tasmanim Arman Behbod Company in Iran.
Category
Treatment - Devices
2
Description
Control group: In the Apotel group, one gram in 10 ml of normal saline was given in recovery and continued for 24 hours postoperatively.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 68 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street