Comparison of ultrasound guided erector spinae plane block with intra-venous fentanyl in the management of refractory renal colic pain
Design
clinical trial with two factorial groups was performed randomly on 40 patients.
Settings and conduct
This study was performed in Bahonar Hospital of Kerman University of Medical Sciences. In one group with refractory renal colic, the spina erector block method was used. In the second group, fentanyl with a starting dose of 1 μg / kg was injected slowly intravenously and under monitoring.
Participants/Inclusion and exclusion criteria
The study population was patients 20-65 years who had renal colic.
Intervention groups
In the group 1, which includes the spina erector block, using the 7.5 MHz (surface) probe of the ultrasound device, which is placed in the paravertebral region (between 5 to 10 cm from the midline) and at the perimeter of the T5 vertebra, the appendix Identification of the vertebrae and fascia of the erected spinach to which it is attached, and needle number 20 under sterile conditions and after permeation under ultrasound-guided approach to the nerve sheath and 20 cc of 1% lidocaine (in patients with the ideal weight below 90 and above 65 kg is calculated based on 4.5 mg / kg of 1% lidocaine solution) at the injection site and diffusion of anesthetic fluid was observed under the fascia of the spina erector. In the group 2, fentanyl with a starting dose of 1 μg / kg was injected slowly intravenously and under monitoring.
Main outcome variables
Complications that can be attributed to any method include headache, nausea, vomiting, dyspnea, arrhythmia and local complications (artery and vein perforation, nerve damage, hematoma) and systemic complications of lidocaine injection and patient satisfaction score in each group of 1 (lowest satisfaction ) To 4 (maximum satisfaction).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220113053709N1
Registration date:2022-01-24, 1400/11/04
Registration timing:retrospective
Last update:2022-01-24, 1400/11/04
Update count:0
Registration date
2022-01-24, 1400/11/04
Registrant information
Name
Javad Darijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 5011
Email address
j.darijani@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
2021-12-22, 1400/10/01
Actual recruitment end date
2022-01-20, 1400/10/30
Trial completion date
2022-01-20, 1400/10/30
Scientific title
Comparison of ultrasound guided erector spinal plane block with intra-venous fentanyl in the management of refractory renal colic pain
Public title
Comparison of ultrasound guided erector spinal plane block with intra-venous fentanyl in the management of refractory renal colic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The study population was patients 20-65 years who had renal colic.
Exclusion criteria:
Patients who had distracting injury
Patients who had not full consciousness or cognitive activity
Patients who had a history of allergies to Lidocaine and fentanyl
Patients who had diseases that interfere with the procedure or pain rating (such as bleeding defects or peripheral neuropathy)
Patients who did not agree to participate in the study or local block
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed by simple randomization using Random software allocation and demographic similarity between the two groups (including age and sex, etc.) was checked. The sample subjects were selected by easy sampling method and were divided into two groups based on the numbers generated by the software. After being randomly placed between the two groups, the individuals underwent one of the two procedures after confirming the informed consent form.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Afzalipour educational and Medical Center- Kerman University of Medical Sciences
Street address
Somayeh Crossroads (Tahmasb Abad)
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2021-12-20, 1400/09/29
Ethics committee reference number
IR.KMU.AH.REC.1400.226
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
pain score
Timepoint
pain score in the start, 30 minute and 60 minute
Method of measurement
Iowa questionnaire
Secondary outcomes
1
Description
complication
Timepoint
start, 30 minute, 60 minute
Method of measurement
Checklist
Intervention groups
1
Description
Intervention group: n the first group, which includes the spina erector block, using the 7.5 MHz (surface) probe of the ultrasound device, which is placed in the paravertebral region (between 5 to 10 cm from the midline) and at the perimeter of the T5 vertebra, the appendix Identification of the vertebrae and fascia of the erected spinach to which it is attached, and needle number 20 under sterile conditions and after permeation under ultrasound-guided approach to the nerve sheath and 20 cc of 1% lidocaine (in patients with the ideal weight below 90 and above 65 kg is calculated based on 4.5 mg / kg of 1% lidocaine solution) at the injection site and diffusion of anesthetic fluid was observed under the fascia of the spina erector.
Category
Treatment - Drugs
2
Description
Intervention group: In the second group, fentanyl with a starting dose of 1 μg / kg was injected slowly intravenously and under monitoring.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar hospital
Full name of responsible person
Mehdi Torabi
Street address
Qharani street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
j.darijani@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Reza Malek Pourafshar
Street address
Somayeh Crossroads (Tahmasb Abad)
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
j.darijani@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr Javad Darijani
Position
Resercher
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Gharani street, Shahid Bahonar hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
j.darijani@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Javad Darijani
Position
Researcher
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Gharani street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
j.darijani@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Javad Darijani
Position
Resercher
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Gharani street, Shahid Bahonar hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
j.darijani@kmu.ac.ir
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
Information about outcome
When the data will become available and for how long
6 month after publish
To whom data/document is available
Researcher
Under which criteria data/document could be used
Any use is permitted for other researchers.
From where data/document is obtainable
Javad Darijani
j.darijani@kmu.ac.ir
What processes are involved for a request to access data/document