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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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