Study of the effect of lumbar arch support in the prevention of low back pain during spinal anesthesia: A clinical trial
Design
This randomized clinical trial design is a parallel design with a control group. This randomized, phase 2-3 study will be performed on 154 patients undergoing surgery. A random number table is used for randomization and participants are assigned to intervention and control groups.
Settings and conduct
This study, which will be conducted in Imam Reza Hospital of Kermanshah, is a single-blinded one. In this single-blinded study, the outcome assessor is unaware of the allocation of individuals to intervention and control groups. Spinal anesthesia for all patients is performed by a specific person with a Quinke needle size 25 in a sitting position using bupivacaine 0.5%. All patients in both control and intervention groups use the same type of bed and mattress.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years old; Patient satisfaction; No history of mental illness.
Exclusion criteria: Patients with a history of taking painkillers (opioids or non-opioids) in the recent week; Having symptoms of high intracranial pressure; Abnormal spinal anatomy such as scoliosis; Coagulation problems; Patients with low back pain under previous spinal anesthesia.
Intervention groups
In the intervention group, patients will be asked to place an air mattress under the lumbar vertebrae according to the anatomical position before surgery and after performing spinal anesthesia in the supine position until the anesthetic effect wears off. No intervention will be performed in the control group
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211019052817N1
Registration date:2021-11-13, 1400/08/22
Registration timing:registered_while_recruiting
Last update:2021-11-13, 1400/08/22
Update count:0
Registration date
2021-11-13, 1400/08/22
Registrant information
Name
Omid Bahiraee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3845 3254
Email address
o_bahiraei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-10, 1400/08/19
Expected recruitment end date
2022-02-08, 1400/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of lumbar arch support in the prevention of low back pain during spinal anesthesia: A clinical trial
Public title
The effect of lumbar arch support in the prevention of low back pain during spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Patient satisfaction
No history of mental illness
Exclusion criteria:
Patients with a history of taking painkillers (opioids or non-opioids) or any drugs in one recent week.
Having symptoms of high intracranial pressure
Abnormal spinal anatomy such as scoliosis
Coagulation problems
Patients with low back pain during previous spinal anesthesia
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
Using a table of random numbers. Patients based on random numbers generated by the program (Excel version 2016 and RANDBETWEEN function) that values less than 5.0 (0.0009-0.000) will be assigned to the intervention group and more than 5.0 (0.500-999) will be assigned to the control group
Blinding (investigator's opinion)
Single blinded
Blinding description
The project partner, who does not know how the volunteers are assigned in the groups, will evaluate the incidence and severity of low back pain in the project.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-11-07, 1400/08/16
Ethics committee reference number
IR.KUMS.MED.REC.1400.055
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain intensity
Timepoint
6 hours, 24 hours and 7 days after surgery
Method of measurement
The visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, patients will be asked to place an air mattress under the lumbar vertebrae according to the anatomical position before surgery and after performing spinal anesthesia in the supine position until the anesthetic effect wears off.
Category
Treatment - Other
2
Description
No intervention will be performed in the control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Omid Bahiraei
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
omidbahiraee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Omid Bahiraei
Position
Resident anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
omid39bahiraee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Javad Amini Saman
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
aminisaman399@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Omid Bahiraei
Position
Resident anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
omid39bahiraee@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD