Protocol summary

Study aim
Comparing the effects of bupivacaine and bupivacaine-methylprednisolone in ultrasound guided erector spinae plane block on post operative pain in Lumbar spine surgery
Design
Clinical trial with control and intervention group, single blind, on 64 patients, randomized with sealed envelope.
Settings and conduct
Patients referred to Luqman Hospital are divided into two intervention and control groups of 32 people by block randomization. After anesthesia with the same method, both groups will be placed in the prone position before the surgery under ultrasound guidance under bilateral erector spina block at the level of the surgical site. Paramedian sagittal ultrasound probe, about 2 cm outside the spinous processes, we find the transverse process on the same side. We insert the needle caudal to the cranial so that the tip of the needle hits the transverse process. If the needle site is suitable, 20 cc of bupivacaine-methylprednisolone will be injected in the intervention group and 20 cc of bupivacaine 0.25% in the control group. Isoflurane and opioid consumption during surgery, pain, nausea and vomiting during recovery and sugar measurement The blood will be determined up to 24 hours later, as well as the pain level of the patient up to one month.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients 18-65 years old; Normal kidney and liver function; ASA score 1-2; Patient consent ; No history of allergies to local anesthetics; No drug addiction Exclusion criteria:, Increase the scope of surgery to more than three level ,time of surgery for more than 6 hours; No diabetes
Intervention groups
The intervention group, after anesthesia and changing to the prone position, ,are subjected to erector spinae block with bupivacaine-methylprednisolone, and the control group are subjected to block with bupivacaine
Main outcome variables
Consumption of isofluran , opioids, pain score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210415050983N6
Registration date: 2024-04-18, 1403/01/30
Registration timing: prospective

Last update: 2024-04-18, 1403/01/30
Update count: 0
Registration date
2024-04-18, 1403/01/30
Registrant information
Name
Sogol Asgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8836 3185
Email address
drasgari98429@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of bupivacaine and bupivacaine-methylprednisolone in ultrasound guided erector spinae plane block on postoerative pain in Lumbar spine surgery
Public title
Comparing the effects of bupivacaine and bupivacaine-methylprednisolone in ultrasound guided erector spinae plane block on postoerative pain in Lumbar spine surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18-65 years old are candidates for two or three level spine surgery ASA score 1-2 Normal kidney and liver function Patient consent to perform the block No history of allergies to local anesthetics No drug addiction No diabetes
Exclusion criteria:
Increase the scope of surgery to more than three level Extending the length of surgery for more than 6 hours Block site infection or systemic History of anticoagulant use
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Randomized Blocks :In this method, 10 random blocks are generated by computer. Each block includes 5 people in the intervention group and 5 people in the control group. The order of these people is randomly arranged by computer and people are assigned to groups in the same way. At the end of each block, a new block of 10 is produced and this process will continue until the final sample volume is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study are unaware of the groupings because the intervention is performed after anesthesia. The patient's clinical caregiver, the evaluator and recorder of the results, and the data analyzer are not aware of the grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice for Research and Technology, Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yemen Street, Shahid Shahriari Square
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-01-24, 1402/11/04
Ethics committee reference number
IR.SBMU.MSP.REC.1402.575

Health conditions studied

1

Description of health condition studied
Lumbar discopathy
ICD-10 code
M51.36
ICD-10 code description
Other intervertebral disc degeneration, lumbar region

Primary outcomes

1

Description
Intraoperative isoflurane Consumption in tow groups
Timepoint
Before the start of anesthesia and after the end of anesthesia
Method of measurement
By a graduated glass based on mL

2

Description
Intraoperative fentanyl consumption in the two groups
Timepoint
End of surgery
Method of measurement
Dosage consumed based on mcg

3

Description
Pain after surgery
Timepoint
0, 1 and 6 hours after surgery and one month after surgery
Method of measurement
NRS

4

Description
blood sugar
Timepoint
After surgery up to 24 months
Method of measurement
Blood test

Secondary outcomes

1

Description
nausea and vomiting
Timepoint
0, 1 and 6 hours after surgery
Method of measurement
Ask the patient

Intervention groups

1

Description
Control group: After anesthesia and change of position to peron before surgery, in sterile conditions, using peripheral nerve block needle (stimuQuik, ARROW use) with sonosite-Nerve Ultrasound system under the erector spina block One-sided and each-sided injection of 20 ml of 0.25% bupivacaine was performed by a trained anesthesiologist in accordance with standard guidelines.A 5-8MHz liner probe is used for nerve block ultrasound guides. After selecting the target process transducer, the sagittal paramedic prop is placed about 2 cm outside the spinous processes so that the process transducer can be seen in the same direction. Insert the needle inplean the codal from the cranial to cudal until the tip of the needle hits the process transducer. 1-2 cc of local anesthetic is injected to ensure the correct location of the needle. If the location of the needle is suitable, the medicine is injected. The needle point is towards the posterior and inferior side.
Category
Treatment - Drugs

2

Description
Intervention group: Intervention group: After anesthesia and change of position to peron before surgery, in sterile conditions, using peripheral nerve block needle (stimuQuik, ARROW use) with sonosite-Nerve Ultrasound system under the erector spina block One-sided and each-sided injection of 20 ml of Bupivacaine and methylprednisolone 40 was performed by a trained anesthesiologist in accordance with standard guidelines.A 5-8MHz liner probe is used for nerve block ultrasound guides. After selecting the target process transducer, the sagittal paramedic prop is placed about 2 cm outside the spinous processes so that the process transducer can be seen in the same direction. Insert the needle inplean the codal from the cranial to cudal until the tip of the needle hits the process transducer. 1-2 cc of local anesthetic is injected to ensure the correct location of the needle. If the location of the needle is suitable, the medicine is injected. The needle point is towards the posterior and inferior side.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Sogol Asgari
Street address
South Kargar St. - Kamali St. - Special St.
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5291
Email
drasgari98429@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Ziaei
Street address
Velenjak, Yemen Street, Shahid Shahriari Square
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
aliziai@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Sogol Asgari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
South Kargar St. Kamali St. Special Loghman Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
Drasgari98429@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sogol Asgari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
South Kargar St. Kamali St. Special Loghman Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
Drasgari98429@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sogol Asgari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Velenjak, Yemen Street, Shahid Shahriari Square
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
Drasgari98429@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
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