Studying the effect of intravenous Propofol used with two different volumes of local anesthetic(Bupivacaine) on sensory and motor blockade in patients undergoing upper limb surgery by sonographic supraclavicular brachial plexus block approach
This study is performed as a controlled randomized clinical trial in order to sedate with a better quality by lower volumes of local anesthetic(Bupivacaine) in patients undergoing upper limb surgery by sonographic supraclavicular brachial plexus blockade. Inclusion and exclusion criteria are applied. Inclusion Criteria are: ages between 20 and 50; ASA classes: I,II,III; BMI under 35; absence of the history of drug induced hypersensitivity; taking of informed consent. Exclusion Criteria are: failure of supraclavicular blockade; need to general anesthesia. Supraclavicular blockade is performed by sonographic guidance after taking informed consent from the patients and randomized division of the patients into 3 different groups based on the use of Propofol or placebo with different volumes of local anesthetic(Bupivacaine). Demographic information and pain score is obtained by interviewing the patients. The onset and duration of sensory and motor blockage is determined by Pinprick Test and Lovett Rating Scale. Hemodynamic information is obtained by monitoring the patients by digital equipments. The onset and duration of sensory and motor blockage is compared in these 3 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021430855N1
Registration date:2017-02-14, 1395/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-14, 1395/11/26
Registrant information
Name
Mehrdad Sadri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3724 9292
Email address
m-sadri@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, The Vice-Chancellery for Research
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of intravenous Propofol used with two different volumes of local anesthetic(Bupivacaine) on sensory and motor blockade in patients undergoing upper limb surgery by sonographic supraclavicular brachial plexus block approach
Public title
The Effect of Intravenous Propofol on Local Anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Ages between 20 and 50; ASA classes: I,II,III; BMI under 35; Absence of the history of drug induced hypersensitivity; Taking of informed consent
Exclusion Criteria: Failure of supraclavicular blockade; Need to General Anesthesia
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences, School of Medicine
Street address
Plate 23, 16th of Azar St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2016-11-22, 1395/09/02
Ethics committee reference number
medicine2IR.TUMS.MEDICINE.REC.1395.1082
Health conditions studied
1
Description of health condition studied
Supraclavicular Blochade of the Brachial Plexus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of Motor Blockage
Timepoint
During and after the intervention
Method of measurement
Physical examination by the physician
2
Description
Duration of Sensory Blockage
Timepoint
During and after the intervention
Method of measurement
Physical examination by the physician
3
Description
Onset of the Motor Blockage
Timepoint
During the intervention
Method of measurement
Physical examination by the physician
4
Description
Onset of the Sensory Blockage
Timepoint
During the intervention
Method of measurement
Physical examination by the physician
Secondary outcomes
1
Description
Patient's feeling of pain
Timepoint
After the intervention in the same admission
Method of measurement
Visual Analogue Scale (VAS)
2
Description
The measure of motor blockade
Timepoint
During and after the intervention
Method of measurement
Lovett Rating Scale
3
Description
The time of the first opioid request by the patient
Timepoint
After the intervention in the same admission
Method of measurement
By using PCA(Patient Controlled Anaesthesia)
4
Description
Administered opioid dosage in 24 hours
Timepoint
After the intervention in the same admission
Method of measurement
Patient Medical Document
5
Description
Duration of the surgery
Timepoint
During the intervention
Method of measurement
Patient Medical Document
6
Description
Nausea and vomiting after the surgery
Timepoint
After the intervention in the same admission
Method of measurement
Asking the patient
7
Description
Mean arterial blood pressure 1 minute after the blockade
Timepoint
1 minute after the blockade
Method of measurement
Non-invasive automatic manometer
8
Description
Mean arterial blood pressure 3 minutes after the blockade
Timepoint
3 minutes after the blockade
Method of measurement
Non-invasive automatic manometer
9
Description
Mean arterial blood pressure 5 minutes after the blockade
Timepoint
5 minutes after the blockade
Method of measurement
Non-invasive automatic manometer
10
Description
Mean arterial blood pressure 1 minute after the recovery
Timepoint
1 minute after recovery admission
Method of measurement
Non-invasive automatic manometer
11
Description
Mean arterial blood pressure 3 minutes after the recovery
Timepoint
3 minutes after the recovery admission
Method of measurement
Non-invasive automatic manometer
12
Description
Mean arterial blood pressure 5 minutes after the recovery
Timepoint
5 minutes after the recovery admission
Method of measurement
Non-invasive automatic manometer
13
Description
Heart rate 1 minute after the blockade
Timepoint
1 minute after the blockade
Method of measurement
Pulse Oxymetery
14
Description
Heart rate 3 minutes after the blockade
Timepoint
3 minutes after the blockade
Method of measurement
Pulse Oxymetery
15
Description
Heart rate 5 minutes after the blockade
Timepoint
5 minutes after the blockade
Method of measurement
Pulse Oxymetery
16
Description
Heart rate 1 minute after the recovery
Timepoint
1 minute after the recovery admission
Method of measurement
Pulse Oxymetery
17
Description
Heart rate 3 minutes after the recovery
Timepoint
3 minutes after the recovery admission
Method of measurement
Pulse Oxymetery
18
Description
Heart rate 5 minutes after the recovery
Timepoint
5 minutes after the recovery admission
Method of measurement
Pulse Oxymetery
Intervention groups
1
Description
Supraclavicular injection of 30ml Bupivacaine 0.5% + Administration of 25mcg/kg/min IV Propofol
Category
Treatment - Drugs
2
Description
Supraclavicular injection of 20ml Bupivacaine 0.5% + Administration of 25mcg/kg/min IV Propofol
Category
Treatment - Drugs
3
Description
Supraclavicular injection of 30ml Bupivacaine 0.5% + Administration of 25mcg/kg/min IV normal saline as placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, The Vice-Chancellery for Research
Full name of responsible person
Mehrdad Sadri
Street address
5th floor, Central Building of Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, The Vice-Chancellery for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Medicine
Full name of responsible person
Mehrdad Sadri
Position
Medical student(Intern)
Other areas of specialty/work
Street address
Dormitory of Tehran University of Medical Sciences, 16th St, Kargar Shomali St
City
Tehran
Postal code
Phone
008337249292
Fax
Email
m.sadri71@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shariati Hospital
Full name of responsible person
Dr. Reza Atef Yekta
Position
Anesthesiology and Critical Care Medicine
Other areas of specialty/work
Street address
Shariati Hospital, Jalal Al Ahmad crossroad, Kargar Shomali St, Tehran
City
Tehran
Postal code
Phone
+218 4901
Fax
Email
rezaatefyekta@yshoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mehrdad Sadri
Position
Medical Student(Intern)
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 83 3724 9292
Fax
Email
m.sadri71@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)