Comparison of the effect of neostigmine and placebo in combination with ropivacaine on the onset and severity of axillary block in patients undergoing hand and forearm surgery.
Comparison of the effect of neostigmine and placebo in combination with ropivacaine on the onset and severity of axillary block in patients undergoing hand and forearm surgery.
Design
This study is a clinical trial with a control group, with parallel groups, double-blind, randomized on 40 patients. We use the block randomization method for randomization.
Settings and conduct
After obtaining informed consent, patients are divided into two groups. After standard monitoring is connected, 200cc of Ringer's serum is injected, patients are sedated by injecting 0.15mg/kg midazolam and 1.5μg/kg fentanyl. Then, with the simultaneous use of ultrasound and neurostimulator, the brachial plexus nerves were identified in the axillary region, and in the first group, 30 cc of 0.5% ropivacaine and 500 μg of neostigmine (31 cc in total) were injected for axillary block.In the second group, 30 cc of ropivacaine 0.5% and 1 cc of distilled water are injected as a placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate patients for hand and forearm surgery; patients with ASA I, II anesthesia level.
Exclusion criteria: Allergy to local anestheticsl congenital and acquired neuromuscular diseases.
Intervention groups
Intervention group: patients undergoing hand and forearm surgery in which ropivacaine and neostigmine are used for axillary block.
Control group: patients undergoing hand and forearm surgery in which ropivacaine and placebo are used for axillary block.
Comparison of the effect of neostigmine and placebo in combination with ropivacaine on the onset and severity of axillary block in patients undergoing hand and forearm surgery.
Public title
The effect of neostigmine drug on the onset and intensity of regional anesthesia in upper limb surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for hand and forearm surgery
Patients with ASA I, II anesthesia level
Exclusion criteria:
Allergy to local anesthetics
Congenital and acquired neuromuscular diseases
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.
To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks.
For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit.
Here, based on the block 4, we divide patients into groups.
1. TTCC 2. TCTC 3. TCCT
4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8874113911
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.IUMS.FMD.REC.1401.120
Health conditions studied
1
Description of health condition studied
Upper extremity surgery
ICD-10 code
L02.52
ICD-10 code description
Furuncle hand
Primary outcomes
1
Description
Regional anesthesia onset time
Timepoint
During of surgery
Method of measurement
Using a timer
2
Description
Regional anesthesia intensity
Timepoint
During surgery
Method of measurement
A questionnaire designed by the researcher using the patient's information and the anesthesiologist's opinion.
Secondary outcomes
1
Description
Pain from surgery
Timepoint
During surgery
Method of measurement
Using the Visual Analogue Scale pain questionnaire
Intervention groups
1
Description
Intervention group: After obtaining informed consent, patients are divided into two groups. After standard monitoring is connected, 200cc of Ringer's serum is injected, patients are sedated by injecting 0.15mg/kg midazolam and 1.5μg/kg fentanyl. Then, with the simultaneous use of ultrasound and neurostimulator, the brachial plexus nerves were identified in the axillary region, and in the first group, 30 cc of 0.5% ropivacaine (Made by Jalinous Pharmaceutical Company) and 500 μg of neostigmine (Made by Jalinous Pharmaceutical Company) (31 cc in total) were injected for axillary block. Then, the onset time and intensity of regional anesthesia are recorded using a suitable questionnaire.
Category
Treatment - Drugs
2
Description
Control group: After obtaining informed consent, patients are divided into two groups. After standard monitoring is connected, 200cc of Ringer's serum is injected, patients are sedated by injecting 0.15mg/kg midazolam and 1.5μg/kg fentanyl. Then, with the simultaneous use of ultrasound and neurostimulator, the brachial plexus nerves were identified in the axillary region, and in the first group, 30 cc of 0.5% ropivacaine (Made by Jalinous Pharmaceutical Company) and One cc of distilled water (Made by Jalinous Pharmaceutical Company) (31 cc in total) were injected for axillary block. Then, the onset time and intensity of regional anesthesia are recorded using a suitable questionnaire.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Elham Shasti
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
Shastielham@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8670 5503
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Elham Shasti
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
Shastielham@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Shasti
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
Shastielham@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Shasti
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
Shastielham@yahoo.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