Protocol summary

Study aim
Determining the effect of adding dexmedetomidine, dexamethasone, and sodium bicarbonate to ropivacaine in the ultrasound-guided supraclavicular block on the quality of the block in orthopedic surgery
Design
A clinical trial with the control group, parallel groups, three-way blind, randomized, phase 3 on 120 patients. Random Allocation software was used for randomization.
Settings and conduct
Patients are placed in a semi-sitting position (30 degrees), then the supraclavicular block is performed by an ultrasound guide and half of the drug is injected in the pocket corner and the other half in the middle of the brachial plexus. All injections are performed using a spinal needle No. 22 connected to the Extension tube. The drug used for the block is prepared and coded by the project partner as follows and is provided to the executor. The codes are provided to the executor after sampling and statistical analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 years and older Weight (Lean body mass) between 50 to 90 kg ASA 1 and 2 were Introduced for upper limb surgery (distal to the lower third of the arm) Exclusion criteria: Local infection at the site of the block Existence of coagulation disorder or taking anticoagulants Hypersensitivity to dexmedetomidine, dexamethasone, and ropivacaine
Intervention groups
In all patients, the supraclavicular block is performed under ultrasound guide by injection of 30 ml of ropivacaine 5 mg/ml by the performer. In the first to third groups, the following items are added in a volume of one ml, respectively: 30 micrograms of dexmedetomidine, 0.6 ml of 7.5% bicarbonate solution, 4 mg (1 ml) of dexamethasone In the control group, 1 ml of normal saline is added to the drug.
Main outcome variables
Interval of drug injection to the onset of sensory and motor block, duration of sensory and motor block

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140129016415N9
Registration date: 2022-06-26, 1401/04/05
Registration timing: registered_while_recruiting

Last update: 2022-06-26, 1401/04/05
Update count: 0
Registration date
2022-06-26, 1401/04/05
Registrant information
Name
Mohammad Golparvar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3220 1750
Email address
golparvar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-05, 1401/03/15
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of effects of adding Dexmedetomidine, Dexamethasone and Na Bicarbonate to Ropivacaine in ultrasound-guided supraclavicular block on the quality of the block in orthopedic surgery
Public title
Evaluation of effects of adding Dexmedetomidine, Dexamethasone and Na Bicarbonate to Ropivacaine in ultrasound-guided supraclavicular block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and older Weight (Lean body mass) between 50 to 90 kg ASA 1 and 2 Introduced for upper limb surgery (distal to the lower third of arm)
Exclusion criteria:
Local infection at the site of the block Existence of coagulation disorder or taking anticoagulants Hypersensitivity to dexmedetomidine, dexamethasone and ropivacaine
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are placed in one of four experimental groups using a table of random numbers. The default movement in the table from right to left and from bottom to top is considered and the numbers 0 to 29 in group 1 and the numbers 30 to 59 in group 2 and the numbers 60 to 89 in group 3 and the numbers 90 to 119 They are in group 4. The starting point of the movement in the table is determined randomly by the first client by placing a finger with his eyes closed on the table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The project partner prepared the drug used to perform supraclavicular block by adding additive (dexmedetomidine, sodium bicarbonate, dexamethasone, or normal saline) to ropivacaine in similar syringes and in the same final volume and after coding (1 to 4) It is provided to the executor, the executor (drug injector and data collector) and the patient are not aware of the type of drug added to the injectable ropivacaine and the codes will be opened after sampling and statistical analysis are completed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No.100, Jahan-nama valley, Babalrahmeh street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8136656433
Approval date
2022-04-12, 1401/01/23
Ethics committee reference number
IR.MUI.MED.REC.1401.019

Health conditions studied

1

Description of health condition studied
upper limb surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The interval between the injection of the drug and the onset of anesthesia and immobility
Timepoint
Every 3 minutes
Method of measurement
Evaluation of the movement block is done using 2 movement examinations: 1- Asking the patient to place the index and middle fingers against each other while the other fingers are in the extension position 2- Maintaining the forearm position in a 90 degree position with the arm in a position The performer places the patient's arm perpendicular to the patient's body. The sensory block is evaluated by pressing the Blunted needle on the three points of the dorsal hand, forearm and arm.

Secondary outcomes

1

Description
Duration of sensory and motor block
Timepoint
Every 15 minutes
Method of measurement
Evaluation of the movement block is done using 2 movement examinations: 1- Asking the patient to place the index and middle fingers against each other while the other fingers are in the extension position 2- Maintaining the forearm position in a 90 degree position with the arm in a position The performer places the patient's arm perpendicular to the patient's body. The sensory block is evaluated by pressing the Blunted needle on the three points of the dorsal hand, forearm and arm.

Intervention groups

1

Description
First intervention group: 30 micrograms of dexmedetomidine in 1 ml of normal saline is added to the 30 ml of ropivacaine used to block.
Category
Treatment - Drugs

2

Description
Second intervention group: 0.6 ml of 7.5% bicarbonate solution is increased to 1 ml with normal saline and then added to Block drug (30 CC ropivacaine)
Category
Treatment - Drugs

3

Description
Third intervention group: 4 mg (1 ml) of dexamethasone is added to the 30 ml of ropivacaine used to block.
Category
Treatment - Drugs

4

Description
Control group: 1 ml of normal saline is added to 30 ml of ropivacaine used to block.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Mohammad Golparvar
Street address
No.100, Jahan nama valley, Babalrahmeh street, Isfahn, Iran
City
Isfahan
Province
Isfehan
Postal code
8136656433
Phone
+98 31 3220 1750
Email
golparvar@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mansoor Siavash
Street address
No.4 Headquarters building, Isfahan university of Medical Sciences, hezarjarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Golparvar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.100, Jahan nama valley, Babalrahmeh street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8136656433
Phone
+98 31 3220 1750
Email
golparvar@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Golparvar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.100, Jahan nama valley, Babalrahmeh street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8136656433
Phone
+98 31 3220 1750
Email
golparvar@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Golparvar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.100, Jahan nama valley, Babalrahmeh street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8136656433
Phone
+98 31 3220 1750
Email
golparvar@med.mui.ac.ir

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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