Evaluating the Effect of adding Dexamethasone to Lidocaine 1.5% in Infraclavicular Block with Ultrasound Guide on the Onset of Effect and Duration of Block
Evaluating the Effect of adding Dexamethasone to Lidocaine 1.5% in Infraclavicular Block on the Onset of Effect and Duration of Block
Design
Clinical trial with control group, with parallel, double-blind and randomized groups
Settings and conduct
In this study, patients who have referred to Kowsar Hospital in Sanandaj for treatment of upper limb fractures (below the arm) are assessed. Therefore, dividing patients into intervention and control groups randomly, the effect of adding dexamethasone to lidocaine to perform infraclavicular block at the onset and duration of the effect is evaluated. This study was performed in a double-blind manner and patients, outcome assessors and physicians were not studied by grouping patients.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1.Age 18 to 60 years old
2. Placement in ASA classification of class 1 and 2
3. Need orthopedic surgery to repair an upper limb fracture (below the arm)
Non-Inclusion Criteria:
1. Coagulation disorder based on tests (INR> 1.4)
2. History of liver, kidney, peptic ulcer disease
3. History of uncontrolled diabetes
4. Infection in the area of nerve block
5. Hypersensitivity to local anesthetics or dexamethasone
6. History of long-term use of corticosteroids
7. History of drug addiction or drug use
8. Pregnancy
Intervention groups
Intervention Group:
33 ml of 1.5% lidocaine solution (495 mg) and 2 ml of dexamethasone (Dexadic - Caspian Supply Pharmaceutical Company) (8 mg) will be used for Infraclavicular Block .
Control Group:
33 ml of 1.5% lidocaine solution (495 mg) and 2 ml of normal saline (placebo) will be used for Infraclavicular Block .
Main outcome variables
1. The onset of analgesia and immobility
2. The ِduration of analgesia and immobility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220120053774N1
Registration date:2022-02-05, 1400/11/16
Registration timing:prospective
Last update:2022-02-05, 1400/11/16
Update count:0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Aram Khaledian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3361 1232
Email address
aramkhaledian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of adding Dexamethasone to Lidocaine 1.5% in Infraclavicular Block with Ultrasound Guide on the Onset of Effect and Duration of Block
Public title
The effect of adding dexamethasone to lidocaine in infraclavicular block on the onset and duration of block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years old
ASA classification Status 1 and 2
Need to orthopedic surgery to repair an upper limb fracture (below the arm)
Exclusion criteria:
Coagulation disorder (INR> 1.4)
History of liver, kidney, peptic ulcer disease
History of uncontrolled diabetes
Infection in the area of nerve block
History of hypersensitivity to local anesthetics or dexamethasone
History of long-term use of corticosteroids
History of addiction or narcotic use
Pregnancy
Changing the anesthesia plan during surgery from nerve block to general anesthesia
Hemodynamic instability
Patient request to leave the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done randomly using computer generated random numbers. Thus, each "odd number" produced belongs to group 1 ( intervention group) and each randomly generated "even number" belongs to group 2 (patient placement in the control group).
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind this study, patients do not know which study groups they are in. Also, the combination of lidocaine-dexamethasone solution or lidocaine-placebo, in the same volume of 36 ml, is prepared and coded by a nurse colleague who is not present in the study. The anesthesiologist who also performs the procedure is not aware of the prescription drug and the grouping of patients. Patients will be evaluated by an anesthesia assistant who is not in the study group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Approval date
2021-12-21, 1400/09/30
Ethics committee reference number
IR.MUK.REC.1400.233
Health conditions studied
1
Description of health condition studied
Upper limb fractures
ICD-10 code
S.52
ICD-10 code description
Injuries to the elbow and forearm
Primary outcomes
1
Description
The onset of analgesia
Timepoint
Every 5 minutes to complete block.
Method of measurement
Using a question from the patient and using a pinprick test, using a needle with mild skin irritation (normal sense of zero score, inability to understand pinprick score 1 and lack of sense of touch score 2) will be used. To ensure analgesia, a score of 1 sensory block is acceptable. The patient's sensory block is assessed and the patient's onset of analgesia is recorded in a questionnaire. Motion block is also measured using a modified bromage scale. In this way, points are given from zero to 4 (full strength of related muscles, score 4, decrease in muscle strength but the ability to move against resistance 3, ability to move against gravity 2, slight muscle jump 1 and inability to move zero score).
2
Description
The ِduration of analgesia
Timepoint
Every 5 minutes to 30 minutes after injection of block solution, during surgery and then every 30 minutes until complete removal of sensory and motor block in recovery and ward
Method of measurement
Pain in the recovery ward using the Visual Analogue Scale (VAS), which is a numerical scoring scale (zero painless to 10 highest pain).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 33 ml of 1.5% lidocaine solution (495 mg) and 2 ml of dexamethasone (Dexadic - Caspian Supply Pharmaceutical Company) (8 mg) will be used for Infraclavicular Block .
Category
Treatment - Drugs
2
Description
Control group: 33 ml of 1.5% lidocaine solution (495 mg) and 2 ml of normal saline (placebo) will be used for Infraclavicular Block .
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Farzad Sarshivi
Street address
Hamdi Blvd - Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713663
Phone
+98 87 3361 1232
Email
KOWSAR@MUK.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pasadaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4643
Email
Research@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Farzad Sarshivi
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kowsar Hospital - Hamdi Blvd- Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
66177-13663
Phone
+98 87 3361 1231
Email
farzadsarshivi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzad Sarshivi
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kowsar Hospital - Hamdi Blvd- Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
66177-13663
Phone
+98 87 3361 1231
Email
farzadsarshivi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Aram Khaledian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kowsar hospital - Hamdi Blvd - Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713663
Phone
+98 87 3361 1232
Fax
Email
aramkhaledian@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available