Comparison between the analgesic effects of the Erector Spinae Plane Block and direct Infiltration under the Erector Spinae muscles in degenerative lumbar vertebral surgeries
Comparison between the Analgesic Effects of the Erector Spinae Plane Block and Direct Infiltration Under the Erector Spinae muscles in Degenerative Lumbar vertebral Surgeries
Design
A randomized controlled clinical trial with parallel groups, double blinded
Settings and conduct
After approval by the ethics committee of Shahid Beheshti University of Medical Sciences and obtaining the consent of the patients, 64 patients aged between 20-70 years and ASA class I and II who are Degenerative Lumbar Vertebral Surgeries will be randomly assigned to 2 groups according to the table of random numbers.
Participants/Inclusion and exclusion criteria
Inclusion:ASA class I and II
No history of psychiatric diseases
No surgery or fracture in other body parts
Exclusion: BMI over 30
Duration of surgery more than 3 hours
Intervention groups
Group 1: Degenerative Lumbar Vertebral Surgeries using ultrasound-guided erector spinae plane: A C60 curved array ultrasound probe (FUJIFILM SonoSite Edge II Total) with a frequency of 2-5 MHz is used, which is placed in the midline in the parasagittal. By in-plane method using a 20-Ga 4-inch needle, 20 milliliters of ropivacaine 0.25% will be injected bilaterally at the tips of the transverse process under visual guidance.
Group 2: Degenerative Lumbar vertebral Surgeries using Direct Infiltration Under the Erector Spinae muscles: After the midline incision, the fascia is opened in the midline, then the muscles are dissected subperiosteally, and the muscle dissection continues from the transverse process to its lateral part. After laminectomy and screw insertion, at the end of the surgery, 20 cc of 0.25% rupivacaine solution is injected on each side of the device site.
Main outcome variables
intra-operative opioid consumption; Pain
General information
Reason for update
Acronym
ESPB
IRCT registration information
IRCT registration number:IRCT20221107056427N1
Registration date:2022-11-23, 1401/09/02
Registration timing:retrospective
Last update:2022-11-23, 1401/09/02
Update count:0
Registration date
2022-11-23, 1401/09/02
Registrant information
Name
Alireza Mirkheshti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 4287
Email address
amirkheshti@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the analgesic effects of the Erector Spinae Plane Block and direct Infiltration under the Erector Spinae muscles in degenerative lumbar vertebral surgeries
Public title
Determining the effectiveness of erector spinae block under ultrasound guidance in analgesia after lumbar vertebral surgeries
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for degenerative lumbar vertebral surgeries with a maximum of 4 screws in one or two adjacent vertebral levels.
ASA class I and II
No history of psychiatric diseases or drug and stimulant abuse
No surgery or fracture in other body parts
Exclusion criteria:
History of previous lumbar vertebral surgeries
BMI above 30
Duration of surgery more than 4 hours
Bleeding rate more than 20% of body blood volume
Surgery requiring the insertion of more than 4 screws or more than two adjacent lumbar vertebrae
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
A statistics consultant will perform randomization using permuted block technique. The permuted block technique randomizes patients between groups within a set of study participants, called a block. Treatment assignments within blocks are determined so that they are random in order but that the desired allocation proportions are achieved exactly within each block. The randomization sequences are delivered in sealed opaque envelopes to the anesthesiologist responsible for performing the blocks and induction of anesthesia.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before the start of the study and at the time of patient admission, a full explanation is given in relation to the study, and an optional informed consent form is obtained from the patients to participate in the study. The randomization sequences will be delivered in sealed opaque envelopes to the anesthesiologist responsible for performing the blocks and induction of anesthesia. The principal investigator of the project, the medical personnel, the person in charge of data collection (anesthetist assistant), and the person who analyzes the data are also not aware of the grouping of the study.
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
Yemen Street, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.SBMU.MSP.REC.1401.95
Health conditions studied
1
Description of health condition studied
Degenerative Lumbar vertebral Surgeries
ICD-10 code
S32.0
ICD-10 code description
Fracture of lumbar vertebra
Primary outcomes
1
Description
Postoperative analgesia
Timepoint
2, 6, 12 and 24 hours after the operation
Method of measurement
Patient file information
2
Description
morphine intake
Timepoint
2, 6, 12 and 24 hours after the operation
Method of measurement
Patient file information
Secondary outcomes
1
Description
Fentanyl used during surgery
Timepoint
during the surgery
Method of measurement
observation
Intervention groups
1
Description
Intervention group 1: Degenerative Lumbar vertebral Surgeries using Ultrasound-Guided Erector Spinae Plane Block: Bilateral ultrasound-guided ESPBs were performed with the patient in a prone position after induction of general anesthesia, prior to surgical incision. Blocks will be performed by experienced attending anesthesiologists, all of whom were fellowship-trained in regional anesthesia and were members of a dedicated spine anesthesia service. A C60 curved array ultrasound probe (FUJIFILM SonoSite Edge II Total) with 2-5 MHz was placed in parasagittal orientation in the midline to identify the spinous processes. The probe was translated laterally until the tips of the transverse processes were viewed. A 20-Ga 4-inch Ultraplex needle (B. Braun Medical Inc., PA, USA) was placed in-plane and advanced in a cranial-to-caudal direction until the tip was under the erector spinae plane. Depending on the patient's body mass index (BMI) 20 mL 0.25% rupivacaine was injected bilaterally at the tips of the transverse process/under visual guidance.
Category
Treatment - Surgery
2
Description
Intervention group 2: Degenerative Lumbar vertebral Surgeries using Direct Infiltration Under the Erector Spinae muscles: After the midline incision, the fascia is opened in the midline, then the muscles are dissected subperiosteally, and the muscle dissection continues from the transverse process to its lateral part. After laminectomy and screw insertion, at the end of the surgery, 20 cc of 0.25% rupivacaine solution is injected on each side on the device site.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Parisa Raji
Street address
The beginning of Shahid Madani Street, Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
Raji1389@gmail.com
Web page address
https://ehmc.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
Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9331
Email
zarghi@sbmu.ac.ir
Web page address
https://remsp.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
Parisa Raji
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Hussein Medical, Educational, Research and Medical Center, lower than Martyr Madani Metro, Martyr Madani Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
Raji1389@gmail.com
Web page address
https://ehmc.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Raji
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Hussein Medical, Educational, Research and Medical Center, lower than Martyr Madani Metro, Martyr Madani Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
raji1389@gmail.com
Web page address
https://ehmc.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Raji
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Hussein Medical, Educational, Research and Medical Center, lower than Martyr Madani Metro, Martyr Madani Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
Raji1389@gmail.com
Web page address
https://ehmc.sbmu.ac.ir
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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available