Comparison of postoperative pain control results between intracranial and anterior supraspolar nerve block techniques on postoperative pain in patients undergoing shoulder surgery.
Design
Two groups (30 cases each), 2-3 clinical trials, non-randomized, not blinded
Settings and conduct
Shariati Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients undergoing atherosclerotic shoulder surgery, individuals 21 years and older, body mass index 18-35 kg / m2, complete satisfaction with participation in the study
Exclusion criteria
Patients who were unable to consent, people who were chronically treated for opioids, people who were allergic to the drug under study, people with neurological defects, people with advanced lung disease (COPD and uncontrolled asthma), high surgeries 3 hours and people who had any contraindications for local anesthesia such as coagulopathy and local infection.
Intervention groups
60 patients will be randomly divided into two groups (ISB, anterior SSNB) based on exclusion criteria.Intracranial nerve blocks (ISBs) (local anesthesia in the area between the C5 and C6 nerve roots, in the gap between the scalps) and the anterior suprascapular (SSNB) (nerves until they detach from the brachial plexus and from under the ohmoid muscle to the supraclavicular cavity Enters) Under the guidance of ultrasound will be performed by a specialist and experienced physician according to the techniques of anesthesia guidelines. Local anesthesia is then applied outside the suprascapular nerve and just below the omoid muscle.
Main outcome variables
side effects, the first time required opioid in 24 hours after surgery, The amount of opioid required in 24 hours after surgery, Pain scoring
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220425054655N1
Registration date:2022-06-01, 1401/03/11
Registration timing:registered_while_recruiting
Last update:2022-06-01, 1401/03/11
Update count:0
Registration date
2022-06-01, 1401/03/11
Registrant information
Name
Rihanna Khorsandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2241 1632
Email address
khorsandi.rihanna@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pain in patients undergoing shoulder surgery using interscalene in comparison with anterior suprascapular nerve block technique
Public title
Pain in patients undergoing shoulder surgery using interscalene in comparison with anterior suprascapular nerve block technique
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing atherosclerotic shoulder surgery,
People 21 years and older,
body mass index 18-35 kg / m2
Complete satisfaction from participating in the study
Exclusion criteria:
Patients who are unable to express satisfaction
People who have been chronically treated for opioids
People who are allergic to the drugs under study
People with neurological defects
Patients with advanced lung disease (COPD and uncontrolled asthma)
Surgeries over 3 hours
People who have any contraindications to local anesthesia such as coagulopathy and local infection
Age
From 21 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tehran University of Medical Sciences
Street address
Tehran, the intersection of Keshavarz Boulevard and Ghods St., the headquarters of Tehran University of Medical Sciences, sixth floor, Room 605, Research and Technology Affairs Department
City
tehran
Province
Tehran
Postal code
1417613151
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1508
Health conditions studied
1
Description of health condition studied
Patients undergoing shoulder surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain scoring
Timepoint
16 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ISB local anesthesia. Intravenous access is provided and sedation is performed with midazolam (up to 2 mg) and 50 μg fentanyl if necessary. Standard monitors will be used throughout the block and supplemental oxygen will be provided. Intrascal block (ISB) and anterior suprascapular block (SSNB) will be performed under ultrasound guidance. In each group of 15 ml (75 mg) of 0.5% rupivacaine will be used to block. The anterior ISB and SSNB will be performed while the patient is in a supine position. To perform an ISB, an ultrasound scan will be performed to identify the C5, C6, and C7 nerve roots between the scapular muscles. Local anesthesia will be performed in the area between the C5 and C6 nerve roots, in the gap between the scales. Local anesthesia will be performed in the area between the C5 and C6 nerve roots, in the gap between the scales. The success rate of the block in the first 30 minutes after the block will be measured by assessing the degree of sensory and motor block. General anesthesia will be performed with intravenous fentanyl up to 3 micrograms per kilogram of patient weight, propofol 2 milligrams per kilogram of body weight and atracurium 0.5 mg per kilogram of patient weight. Endotracheal tubes are also implanted for patients. Fentanyl will be used in the recovery room if necessary and its amount will be recorded. Pain will be measured by the VAS scale 16 and 24 hours after recovery recovery. The first request for analgesia, the need for analgesia in the first 24 hours after the block, patient satisfaction, and side effects will also be considered. The total number of additional analgesic prescriptions for 48 hours after surgery will also be calculated.
Category
N/A
2
Description
Intervention group: SSNB local anesthesia. Intravenous access is provided and sedation is performed with midazolam (up to 2 mg) and 50 μg fentanyl if necessary. Standard monitors will be used throughout the block and supplemental oxygen will be provided. Intrascal block (ISB) and anterior suprascapular block (SSNB) will be performed under ultrasound guidance. In each group of 15 ml (75 mg) of 0.5% rupivacaine will be used to block. The anterior ISB and SSNB will be performed while the patient is in a supine position. For the anterior SSNB, the nerve will follow until it separates from the brachial plexus and enters the supraclavicular cavity below the ohmoid muscle. Local anesthesia will then be applied outside the suprascapular nerve and just below the omoid muscle. The success rate of the block in the first 30 minutes after the block will be measured by assessing the degree of sensory and motor block. General anesthesia will be performed with intravenous fentanyl up to 3 micrograms per kilogram of patient weight, propofol 2 milligrams per kilogram of body weight and atracurium 0.5 mg per kilogram of patient weight. Endotracheal tubes are also implanted for patients. Fentanyl will be used in the recovery room if necessary and its amount will be recorded. Pain will be measured by the VAS scale 16 and 24 hours after recovery recovery. The first request for analgesia, the need for analgesia in the first 24 hours after the block, patient satisfaction, and side effects will also be considered. The total number of additional analgesic prescriptions for 48 hours after surgery will also be calculated.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان شریعتی
Full name of responsible person
Reza AtefYekta
Street address
Tehran, North Kargar St., Jalal Al-Ahmad Intersection, in front of the Faculty of Economics, Dr. Shariati Research and Treatment Center.
City
tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Ghods St., Poursina St., North Door of the University, Building No. 1, School of Medicine
City
tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3334
Email
okazi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellor in Research Affairs of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Reza Atefyekta
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran, North Kargar St., Jalal Al-Ahmad Intersection, Opposite the Faculty of Economics, Dr. Shariati Research and Training Center
City
tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 0008 4901
Email
khorsandi.rihanna@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza AtefYekta
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
North Kargar St., Jalal Al-Ahmad Three Ways, Opposite the Faculty of Economics, Dr. Shariati Research and Treatment Center
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 0008 4901
Fax
Email
khorsandi.rihanna@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reihane Khorsandi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
North Kargar St., Jalal Al-Ahmad Three Ways, Opposite the Faculty of Economics, Dr. Shariati Research and Treatment Center
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 0008 4901
Email
khorsandi.rihanna@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
Not applicable
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 is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period starts 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
The use of data and documents is permitted in accordance with what will be extracted from the article.
From where data/document is obtainable
Reza AtefYekta
What processes are involved for a request to access data/document
Six months after the publication of the article, the application will be reviewed by the project manager and submitted as soon as possible.