Comparative assessment of the effectiveness of Erector Spina plane block with Thoracic Epidural anesthesia on postoperative pain of patients undergoing thoracic surgery.
Comparing the effectiveness of Erector Spina plane block to Thoracic Epidural anesthesia on postoperative analgesia in patients undergoing thoracic surgery
Design
A single blind, controlled clinical trial
Settings and conduct
76 patients aged 18 to 74, candidates for thoracic surgery, referred to Masih Daneshvari Hospital in Tehran, were divided into two groups of 38 by simple sequential randomization. Patient blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients aged 18 to 74, candidates for thoracic surgery.
Exclusion criteria: patients with spinal deformity or history of addiction; coagulation disorder; Sensitivity to local anesthetic drugs and diseases related to nerve fibers.
Intervention groups
Intervention group: 38 patients will receive 20 ml of Bupivacaine 0.25% within erector spina plane block before surgery. For erector spina plane block one-sided single injection will be done deep in the erector spina muscle at the level of fifth thoracic vertebra
Control group: 38 patients will receive 10 ml of Bupivacaine 0.25% via epidural catheter before surgery. The epidural catheter will be inserted before initiating surgery at the level of T6-T7.
Main outcome variables
Postoperative pain after thoracic surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230314057715N1
Registration date:2023-09-01, 1402/06/10
Registration timing:retrospective
Last update:2023-09-01, 1402/06/10
Update count:0
Registration date
2023-09-01, 1402/06/10
Registrant information
Name
Jalil Sadeghi Bakhshmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2214 1399
Email address
jalilsadeghi824@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-18, 1402/03/28
Expected recruitment end date
2023-08-19, 1402/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment of the effectiveness of Erector Spina plane block with Thoracic Epidural anesthesia on postoperative pain of patients undergoing thoracic surgery.
Public title
Effectiveness of Erector spina plane block, Effectiveness of Thoracic epidural anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing thoracic surgery
Age: 18 to 74 years
Exclusion criteria:
Patient dissatisfaction
History of drug addiction
History of allergy to local anesthetics
History of coagulation disorders
Critically ill patients, evidence of sepsis and patients who will require mechanical ventilation after surgery
Patients with chest deformity
Patients with neurological disorders and axonal diseases
Age
From 18 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who will do the analysis will be blind to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Medicin-Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, School of medicine, Erabi street, Yaman street, Shahid Chamran highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1451744791
Approval date
2023-03-07, 1401/12/16
Ethics committee reference number
IR.SBMU.MSP.REC.1401.722
Health conditions studied
1
Description of health condition studied
Postoperative pain in thoracic surgery.
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Numerical score of pain after thoracic surgery
Timepoint
1 hour after surgery, 3 hours after surgery, 6 hours after surgery and 12 hours after surgery.
Method of measurement
Asking the patient based on the numerical pain score.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 38 patients will receive 20 ml of Bupivacaine 0.25% within erector spina plane block before surgery. For erector spina plane block one-sided single injection will be done deep in the erector spina muscle at the level of fifth thoracic vertebra.
Category
Treatment - Other
2
Description
Control group: 38 patients will receive 10 ml of Bupivacaine 0.25% via epidural catheter before surgery. The epidural catheter will be inserted before initiating surgery at the level of T6-T7.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Tahereh Parsa
Street address
Darabad ,Nyavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Fax
+98 21 2610 9490
Email
pr.nritld@sbmu.ac.ir
Web page address
https://nritld.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
5th floor, Building number 2, Shahid Beheshti university of medical sciences, Erabi street, Yaman Street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 2243 9780
Fax
+98 21 2243 9780
Email
info@sbmu.ac.ir
Web page address
https://research.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
Jalil Sadeghi Bakhshmand
Position
Resident of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Darabad Nyavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Fax
+98 21 2610 9490
Email
jalilsadeghi824@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Parsa
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Darabad, nyavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
tparsa849@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jalil Sadeghi Bakhshmand
Position
Resident of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Darabad, Nyavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
jalilsadeghi824@yahoo.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
Upon request by correspondence via email or phone call.
When the data will become available and for how long
6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
To conduct relevant research and meta-analysis.
From where data/document is obtainable
National Research Institute of Tuberculosis and Lung Diseases
What processes are involved for a request to access data/document
Correspondence via e-mail with the person in charge of the project, Dr. Tahereh Parsa.