View older revisions Content changed at 2020-05-29, 1399/03/09

Protocol summary

Study aim
The purpose of this study will be to assess the effect of dexmedetomidine with bupivacaine and bupivacaine alone on postoperative pain in upper limb ortopedice surgery with supraclavicular block
Design
Clinical trial with two arm parallel groups, randomised trial with double blinded assessment. Study phase will be 3-2.
Settings and conduct
In Urmia Imam Khomeini hospital operating room after the onset time of the sensory and motor block, the duration of the sensory and motor block and postoperative pain will be measured.
Participants/Inclusion and exclusion criteria
inclusion criteria: aged 20-60 years old; American Society of Anesthesiologists physical status classification I; general anesthesia. Exclusion criteria: history of cardiovascular disease; history of respiratory disease; history of renal disease; history of liver disease; pregnancy; allergy to the drugs studied; contraindication of supraclavicular block; coagulopathy.
Intervention groups
In Intervention group patients will be received 39 ml of bupivacaine 0.25% with 1 ml (1 µg/kg) dexmedetomidine. In control group patients will be received 39 ml of bupivacaine 0.25% with 1 ml saline 0.9%.
Main outcome variables
Duration of the sensory and motor block; post operative pain

General information

Reason for update
Correction of the date of illness getting patient
Acronym
IRCT registration information
IRCT registration number: IRCT20160430027677N15
Registration date: 2019-05-28, 1398/03/07
Registration timing: prospective

Last update: 2020-05-29, 1399/03/09
Update count: 1
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of dexmedetomidine with bupivacaine and bupivacaine alone on postoperative pain in upper limb ortopedice surgery with supraclavicular block
Public title
Evaluation the effect of dexmedetomidine with bupivacaine on postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 20-60 years old American Society of Anesthesiologists physical status classification I General anesthesia
Exclusion criteria:
History of cardiovascular disease History of respiratory disease History of renal disease History of liver disease Pregnancy Allergy to the drugs studied Contraindication of supraclavicular block Coagulopathy
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups of Dexmedetomidine and Bupivacaine (group D) and Bupivacaine (group B) using Random Allocation Software 2.0, and the target codes will be written and placed in sealed envelopes with sequential allocation using double-blind method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist will be unaware of which patient will be assigned to which group. Syringes will be identical and only the operating room nurse will knew about the contents of each of them, and finally, after collecting information from the anesthesia residents, the anesthesiologist will be informed of the group each patient will be assigned to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Emergent Street, Ershad Avenue
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-09-05, 1397/06/14
Ethics committee reference number
IR.UMSU.REC.1397.181

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Generalized pain NOS

Primary outcomes

1

Description
Pain
Timepoint
In recovery, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale

2

Description
Duration of the sensory block
Timepoint
From the onset of the sensory block until the onset of the first pain after surgery
Method of measurement
Pinprick

3

Description
Duration of the motor block
Timepoint
Since full paralysis of limb until complete restoration of limb movement
Method of measurement
Bromage scale

Secondary outcomes

1

Description
Mean Arterial Blood Pressure
Timepoint
During surgery
Method of measurement
None Invasive Blood Pressure

2

Description
Mean pulse Rate
Timepoint
During surgery
Method of measurement
Electrocardiogram

3

Description
Pentazocine consumption
Timepoint
After transferring the patient to the ward in the first 24 hours
Method of measurement
milligram

Intervention groups

1

Description
Intervention group: Patients in Group dexmedetomidine will be received 39 ml of bupivacaine 0.25% with 1 ml (1 µg/kg) dexmedetomidine
Category
Prevention

2

Description
Control group: Patients in Group bupivacaine will be received 39 ml of bupivacaine 0.25% with 1 ml saline 0.9%
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini Hospital, C operating room
Full name of responsible person
Shahryar Sane
Street address
Modarres Boulevard, Ershad Boulevard
City
Uemia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Emergent Street, Ershad Avenue
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ormia 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
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emergrnt Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
sanesh@umsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emergrnt Street, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
sanesh@umsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emergent Street, Ershad Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.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
Not applicable
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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