Protocol summary

Summary
The aim of this study is to compare the level of sensory blockage in spinal anesthesia with bupivacaine %0.5 and lidocaine %5 in surgical patients. Study is a double blind randomized clinical trial. Patients who are candidates for spinal anesthesia and over 16 years old, estimated maximum operation duration until 90 minutes, body mass index(BMI) less than 30 Kg/m2, no history of aspirin and anticoagulant drugs administration at 7 days prior to surgical operation, without columnar deformity, no history of surgical operation on lumbar area, no abscess or infection on the insertion area of spinal needle, no lumbar disc herniation, no history of allergy to bupivacaine and lidocaine, migraine and chronic headache referring to operation room will select for study. pregnant patient, obesity patient with BMI more than 30kg/m2, patient with other than supine position, patient receiving hypnotic and opium drugs will exclude from study. Study population include all patient candidated for spinal anesthesia. sample size is 300 cases:will divide in two groups and each group include 150 cases. quincke spinal needle no 25 insert to L3-L4 interspinous space at sitting position. Lidocaine %5-100mg and bupivacaine %0.5- 15mg will inject in subarachnoid space then patients lie at supine position. intervention time will be 8 months. Pin prick test assessment is done for determination of sensory block level every 5 minutes by needle no 23

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014012416338N1
Registration date: 2014-07-24, 1393/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-24, 1393/05/02
Registrant information
Name
Seyyed Mohsen Pouryaeghobi
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3253 3488
Email address
dr.pooryaghobi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2014-03-06, 1392/12/15
Expected recruitment end date
2014-09-06, 1393/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the level of sensory blockage in spinal anesthesia with bupivacaine %0.5 and lidocaine %5 in surgical patients in Karaj Shahid madani and Bahonar hospital
Public title
Spreading of anesthesia at spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterias: Adult patients over 16 years old؛ maximum surgery duration 150 minutes؛ body mass index(BMI) less than 30 kg/m2؛ without history of taking aspirin and any anticoagulant drugs at 1 week before surgery؛ without spine columnar deformity؛ no history of any surgery at lumbar area؛ without abscess or infection at spinal needle insertion area؛ no involve to lumbar disc herniation؛ no history of allergy to lidocaine and bupivacaine؛ no history of migraine and chronic headache Exclusion criteria: pregnant patients؛ obesity patients with BMI more than 30kg/m2؛ patient with other than supine position؛ patient receiving hypnotic and opium drugs
Age
From 16 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Alborz University of Medical Science
Street address
Shahrak-e-edari, North Taleghani Ave.
City
Karaj
Postal code
Approval date
2013-12-24, 1392/10/03
Ethics committee reference number
2303995

Health conditions studied

1

Description of health condition studied
Spinal anesthesia sensory blockade level
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Bupivacaine
Timepoint
8 months
Method of measurement
mg

2

Description
Lidocaine
Timepoint
8 months
Method of measurement
mg

Secondary outcomes

1

Description
Sensory blockade level
Timepoint
each 5 minutes
Method of measurement
dermatomes anesthsia test

Intervention groups

1

Description
injection of lidocaine%5-100mg into CSF for spinal anesthesia done
Category
Prevention

2

Description
injection of bupivacaine %0.5-15mg into CSF for spinal anesthesia done
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
dr.emad addin mohsen
Street address
Shahid Madani Sq. Jahan shahr
City
Karaj

2

Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Dr. elahi seyyed ahmad
Street address
Kaj Blv.
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz University of Medical Science
Full name of responsible person
Ali
Street address
Shahrak -e-edari,North Naleghani Ave.
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz University of Medical Science
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
Alborz University of Medical Science
Full name of responsible person
Dr. pouryaeghobi seyyed mohsen
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahrak -e-edari, North Taleghani Ave.
City
Karaj
Postal code
Phone
+98 26 3253 3488
Fax
Email
pour.mohsen@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Science
Full name of responsible person
Dr.Pouryaeghobi Seyyed Mohsen
Position
Anesthesiologist
Other areas of specialty/work
Street address
Golestan 6th, Eshteraki Avn.
City
Karj
Postal code
Phone
+98 26 3253 3488
Fax
Email
dr.pooryaghobi@abzums.ac.ir&pour.mohsen@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Science
Full name of responsible person
Dr. pouryaeghobi seyyed mohsen
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahrak -e-edari, North Taleghani Ave.
City
Karaj
Postal code
Phone
+98 26 3253 3488
Fax
Email
pour.mohsen@yahoo.com
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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