Protocol summary

Summary
Sixty patients undergoing lower limb orthopedic surgery with torniquet are studied in this randomized clinical trial. Inclusion criteria: ASA class 1, 2 and aged between 20-65. Exclusion criteria: emergency surgeries;patient dissatisfaction; infection of injection site; high intracranial pressure; coagulopathy; difficulties to communicate with patient in order to evaluate them during surgery; addiction; allergies to spinal anesthetic drugs. Patients are randomly allocated into one of these two groups: A= 12-15 milligram bupivacaine+ 25 microgram fentanyl+ 0.1 milligram epinephrine. B= 12-15 milligram bupivacaine+ 25 microgram fentanyl+ 0.3 milligram epinephrine. Spinal anesthetic is administered in lumbar space in sitting position. Then patients are located in supine position. Patients will receive 0.01-0.03 milligram/kilogram midazolam as sedative. These parameters will be measured 5, 10, 20, 30, 60, 90, 120 minutes after spinal and in post anesthesia care unit: sensory block level will be evaluated by pinprick method and time of reaching to the highest level and 4 dermatome backsliding will be evaluated. Motor block level will be evaluated by bromage scale (0= patient is able to move the hip, knee and ankle; 1= patient is unable to move the hip but is able to move the knee and ankle; 2= patient is unable to move the hip and knee but is able to move the ankle; 3= patient is unable to move the hip, knee and ankle) . Heart rate, blood pressure, nausea and vomiting, apnea, shivering and suffering from pain during surgery and in post anesthesia care unit are recorded and will be treated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201505193829N5
Registration date: 2016-02-16, 1394/11/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-16, 1394/11/27
Registrant information
Name
Pejman Pourfakhr
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 5770
Email address
pourfakhr@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sina Hospital
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of adding different doses of epinephrine to the fentanyl and bupivacaine solution in spinal anesthesia in lower limb orthopedic surgeries with torniquet
Public title
Effects of adding different doses of epinephrine to the fentanyl and bupivacaine solution in spinal anesthesia in lower limb orthopedic surgeries with torniquet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidates of lower limb orthopedic surgeries with torniquet with ASA class I and II; ages between 20-65 Exclusion criteria: emergency surgeries;patient dissatisfaction; infection of injection site; high intracranial pressure; coagulopathy; difficulties to communicate with patient in order to evaluate them during surgery; addiction; allergies to spinal anesthetic drugs
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Sealed Envelolope

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
Taleqani St، Qods St، Enghelab Sq.
City
Tehran
Postal code
Approval date
2015-07-20, 1394/04/29
Ethics committee reference number
IR.TUMS.REC.1394.387

Health conditions studied

1

Description of health condition studied
spinal anesthesia in lower limb orthopedic surgeries
ICD-10 code
XIII
ICD-10 code description
M22, M23

Primary outcomes

1

Description
Sensory Block
Timepoint
After spinal up to reaching to the highest sensory block level and 4 dermatome backsliding
Method of measurement
Pinprick method

2

Description
Motor Block
Timepoint
After spinal up to complete motor block, 10, 20, 30, 60, 90, 120 minutes after spinal
Method of measurement
Bromage scale

Secondary outcomes

1

Description
Atropin
Timepoint
During Surgery
Method of measurement
Usage dose (milligram)

2

Description
Ephedrin
Timepoint
During Surgery
Method of measurement
Usage dose (milligram)

3

Description
Nausea and Vomiting
Timepoint
During and After Surgery
Method of measurement
Observation-Yes/No

Intervention groups

1

Description
Group A : 0.1 mg Epinephrine + 25 microgram Fentanyl + 12-15 mg Bupivacaine.(According Methods) Fentanyl: Darou Pakhsh Company Bupivacaine: Aburaihan Company Epinephrine: Darou Pakhsh Company
Category
Treatment - Drugs

2

Description
Group B : 0.3 mg Epinephrine + 25 microgram Fentanyl + 12-15 mg Bupivacaine.(According Methods) Fentanyl: Darou Pakhsh Company Bupivacaine: Aburaihan Company Epinephrine: Darou Pakhsh Company
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Pejman Pourfakhr
Street address
Sina Hospital، Hasan Abad Sq، Imam Khomeini St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Sina Hospital
Full name of responsible person
Dr. Reza Shariat Moharari
Street address
Sina Hospital، Hasan Abad Sq، Imam Khomeini St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Sina Hospital
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
Sina Hospital
Full name of responsible person
Negin Saeedi
Position
BS-Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital، Hasan Abad Sq، Imam Khomeini St.
City
Tehran
Postal code
Phone
+98 21 6634 8533
Fax
Email
n-saeedi@alumnus.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr. Pejman Pourfakhr
Position
Assistant Professor-Anesthesiologist
Other areas of specialty/work
Street address
Sina Hospital، Hasan Abad Sq، Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
Email
pourfakhr@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Negin Saeedi
Position
BS-Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital، Hasan Abad Sq، Imam Khomeini St.
City
Tehran
Postal code
Phone
Fax
Email
n-saeedi@alumnus.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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