Evaluation of effectiveness of Erector Spina block in pain reduction after lumbar spinal laminectomy surgery
Design
Two parallel group randomized trial with blinded participants and outcome assessment. Each group contains 20 samples randomized by software.
Settings and conduct
In this study all 18-75 y/o patients candidates for laminectomy surgery in Loghman hospital in Tehran will be divided randomly in two groups of case and control. Each group contains 20 samples. After induction of anesthesia and changing the position to prone the case group receive erector spina block under ultrasound guide with bupivacaine 0.25 % , 20 cc each side . The Control group will receive exactly the same anesthetic regimen as Case group.
After surgery the pain score will be recorded in defined intervals. Also opioid consumption in first 24 hour after surgery will be recorded. We will report the results after analyzing the date.
Participants/Inclusion and exclusion criteria
All 18 to 75 y/o patients candidates for 1-3 level lumbar spinal laminectomy surgery with normal renal and hepatic function and ASA score 1-2 Who has not history of addiction nor allergy to local anesthetics and mental disorders will participate in this trial.
Intervention groups
After induction of anesthesia and changing the position to prone the case group receive erector spina block under ultrasound guide with bupivacaine 0.25 % , 20 cc each side . The Control group will receive exactly the same anesthetic regimen as Case group.
Main outcome variables
Pain score in defined intervals after surgery ; Opioid consumption in first 24 hour after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200628047936N1
Registration date:2020-09-27, 1399/07/06
Registration timing:registered_while_recruiting
Last update:2020-09-27, 1399/07/06
Update count:0
Registration date
2020-09-27, 1399/07/06
Registrant information
Name
Arash Tafrishinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 4715
Email address
arashtafrishi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Ultrasound Guided Erector spina block in postoperative pain reduction in lumbar spinal surgeries
Public title
Erector spina block in lumbar spinal surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
All candidated 18-75 y/o patients for spinal lumbar surgery
patients with normal hepatic and renal function
ASA score 1-2
Exclusion criteria:
addiction
BMI more than 35 or less than 16
allergy to local anesthetics
mental disorders
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
All the participants will be divided randomly by using random number table generated by excel software into two groups of intervention and control. Forty patients will participate in this study and 20 of them will be allocated to intervention and the other 20 will enter control group based on randomization numbers which will be generated by excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants and also data recording personal who will not be the same person who performs block, will not be informed about the group of each case.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti Medical Universityکمیته اخلاق دانشگاه علوم
Street address
Loghman Hakim Hospital, Makhsus Ave., South Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1333625445
Approval date
2020-07-12, 1399/04/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.394
Health conditions studied
1
Description of health condition studied
Pain control after spinal surgery
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Postop pain score in defined intervals
Timepoint
1, 2 , 4, 6, 12, 24 Hours after surgery
Method of measurement
Pain scale chart (NRS)
2
Description
Opioid consumption in first postop 24 hours
Timepoint
First 24 hours
Method of measurement
Amount of Opioid consumption recorded by nurse
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:After induction of anesthesia and changing the position to prone the case group receive erector spina block under ultrasound guide with bupivacaine 0.25 % , 20 cc each side
Category
Other
2
Description
Control group: Due to ethics committee suggestion, we will not perform Erector Spinae block with placebo.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Arash Tafrishinejad
Street address
Loghman hospital, Makhsus St. , South Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Aarabi Ave., Yaman Ave., Chamran Blv
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Tafrishinejad
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Unit 7 , No 7, Mahdavi Milani St., Niavaran Ave..
City
Tehran
Province
Tehran
Postal code
1971953319
Phone
+98 21 2273 4715
Fax
Email
arashtafrishi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Tafrishinejad
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Unit 7 , No 7, Mahdavi Milani St., Niavaran Ave..
City
Tehran
Province
Tehran
Postal code
1971953319
Phone
+98 21 2273 4715
Fax
Email
arashtafrishi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Tafrishinejad
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Unit 7 , No 7, Mahdavi Milani St., Niavaran Ave..
City
Tehran
Province
Tehran
Postal code
1971953319
Phone
+98 21 2273 4715
Fax
Email
arashtafrishi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data and results will be reachable without identification info.
When the data will become available and for how long
Data will be reachable 3 month after publication
To whom data/document is available
All academic researchers
Under which criteria data/document could be used
Data can be used only for research and scientific purposes.
From where data/document is obtainable
Requests should be sent via Email to arashtafrishi@gmail.com
What processes are involved for a request to access data/document
Requests should be sent via Email .We will try to provide requested data in 1 month.