Lidocaine as a local anesthetic drug is used for spinal anesthesia for many years without any concern. But recently some reports indicate this drug as a possible cause of some neurologic complications. One of these complications is transient neurologic symptom which in this study we investigated that. The incidence of this complication is very different in articles. In this study we investigated the true incidence of transient neurologic symptom with lidocaine in cesarean section and factors affecting it such as needle type. Materials and methods: sixty women candidate for cesarean delivery were randomly allocated to receive spinal anesthesia with 25-gauge Whitacre needle or Quincke needle. Spinal anesthesia will administer all of patients in sitting position using 75mg lidocaine 5%.the occurrence of TNS recorded in ten consecutive days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404211616N4
Registration date:2014-05-15, 1393/02/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-15, 1393/02/25
Registrant information
Name
Parisa Golfam
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6332
Email address
pgolfam@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-06-01, 1393/03/11
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Incidence of transient neurologic symptom (TNS) following intrathecal anesthesia with lidocaine in cesarean and factors affecting it.
Public title
Incidence of transient neurologic symptom following intrathecal anesthesia with lidocaine in cesarean and factors affecting it.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: women aged 20-40 years old who candidate for elective or urgent cesarean section surgery.
Exclusion criteria: patients with history of chronic pain; use of analgesic drugs; neurologic diseases; morbid obese patients and diabetic patients.
Age
From 20 years old to 40 years old
Gender
Female
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
kermanshah university of medical science
Street address
imam reza hospital,kermanshah
City
kermanshah
Postal code
Approval date
2012-03-03, 1390/12/13
Ethics committee reference number
11152/آ/707/7/پ
Health conditions studied
1
Description of health condition studied
Transient neuorologic syndrom
ICD-10 code
G45.8
ICD-10 code description
Other transient cerebral ischaemic attacks and related syndromes
Primary outcomes
1
Description
Paresthesia
Timepoint
Daily during 1 weak
Method of measurement
according to patient report
2
Description
Pain
Timepoint
Daily during 1 weak
Method of measurement
According to patient report
Secondary outcomes
1
Description
Pain intensity, duration
Timepoint
After spinal anesthesia replenish
Method of measurement
History taking
Intervention groups
1
Description
25 g sprotte needle. Bupivacaine 25 g quincke needle. Bupivacaine
Category
Treatment - Devices
2
Description
25 G sporotte needle, Lidocaine 25 G quincke needle, Lidocaine
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Parisa Golfam
Street address
Imam reza hospital, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences, Research Department
Full name of responsible person
Farid Najafi
Street address
Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences, Research Department
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
Kermanshah University of Medical Sciences
Full name of responsible person
Parisa Golfam
Position
Assistant professor
Other areas of specialty/work
Street address
imam reza hospital,kermanshah,iran
City
Kermanshah
Postal code
Phone
+98 83 1725 5097
Fax
Email
pgolfam@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parisa Golfam
Position
Assistant professor
Other areas of specialty/work
Street address
Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 1725 5097
Fax
Email
pgolfam@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parisa Golfam
Position
Assistant professor
Other areas of specialty/work
Street address
Imam Reza hospital, Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 831427300
Fax
Email
pargolfam@yahoo.com; pgolfam@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)