Objectives: Follow-up of patients undergoing uncomplicated spinal anesthesia have shown that some of them had suffered from pain in the lower extremities. This painful condition that starts immediately after surgery and has a spontaneous and complete improvement is called as transient neurologic symptoms. The aim of this study is to compare the transient neurologic symptoms of lidocaine and bupivacaine after spinal anesthesia in caesarean section.
Design: Simple randomization, double blind, without placebo, trial phase 2, including 150 patients under elective cesarean section.
Setting and conduct: spinal anesthesia will perform with the 25-G Quincke needle.
Participants including major eligibility criteria: All women who are supposed to undergo elective cesarean section.
Intervention: Lidocaine 5%, 75 milligrams, intrathecal injection.
Bupivacaine0.5%, 12 milligrams, intrathecal injection.
Main outcome measures: Tingling and numbness in the thighs and hip, Pain in the lower back and buttocks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404262080N15
Registration date:2014-05-18, 1393/02/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-18, 1393/02/28
Registrant information
Name
Afsaneh Norouzi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 7474
Email address
norouzi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of transient neurologic symptoms induced by lidocaine and bupivacaine after spinal anesthesia in cesarean
Public title
Comparison of transient neurologic symptoms after spinal anesthesia for cesarean
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Women between 20 to 45 years old
2. Term pregnancy
3. Elective cesarean
4. No history of back pain, weakness and numbness in the extremities
Exclusion criteria:
1. Underlying diseases such as pre-eclampsia and eclampsia Hypertension
2. Adding epinephrine or opiate to drugs
3. Using a needle with a larger size
Age
From 20 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Approval date
2012-08-10, 1391/05/20
Ethics committee reference number
91-142-5
Health conditions studied
1
Description of health condition studied
Tingling
ICD-10 code
R20.2
ICD-10 code description
Tingling sensation
Primary outcomes
1
Description
Tingling
Timepoint
Immediately, 6, 12, and 24 hours after cesarean
Method of measurement
based on a scale of four
2
Description
Pain
Timepoint
Immediately, 6, 12, and 24 hours after cesarean
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
75 miligrams of 5% lidocaine, made in Gostaresh Bazargani Daroopakhsh will be injected intrathecally.
Category
Prevention
2
Description
12 miligrams of 0.5% bupivacaine, made in Iran Esalat company will be injected intrathecally.