Pain is one of the most post operative complications in cesarean. Nowadays local anesthesia has been more used due to its advantages. One hundred sixty six pregnant women aged 15-40, with ASA class I or II, are going to enter this double blind randomized trial. They should fulfill the criteria of elective cesarean without neonatal distress. Control group will receive 75-100 mg Lidocaine 5% (based on their height) while case group will receive the same plus 75 mcg Intratechal Clonidine. Pulse rate and blood pressure will be assessed each 5 minutes for the first 20 minutes; each 10 minutes till recovery discharge, then each 4 hours for 12 hours. Analgesia will be assessed just after recovery admission, then each 4 hours for 12 hours, and so, APGAR score will be assessed at first, fifth and tenth minutes after delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901212080N3
Registration date:2010-05-17, 1389/02/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-17, 1389/02/27
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
Deputy of research & education of Arak University of Medical Sciences
Expected recruitment start date
2010-04-10, 1389/01/21
Expected recruitment end date
2010-09-12, 1389/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Intratechal Clonidine in analgesia in elective cesarean
Public title
Impact of Intratechal Clonidine in analgesia in elective cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. age: 15-40 2. ASA score I, II 3. Elective and term cesarean; Exclusion criteria: 1. Emergent cesarean 2. Fetal perinatal distress due to thick meconium, deculment or low APGAR score 3. Patient`s low compliance for entering the study and spinal analgesia 4. positive history of preeclampsia, chronic hypertension, consumption of B-blockers, Antipsychotics or Anti depressants 5. Perioperative Anti emetics use
Age
From 15 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
166
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
Arak University of Medical Sciences
Street address
Alamhoda St.
City
Arak
Postal code
Approval date
empty
Ethics committee reference number
88-65-2
Health conditions studied
1
Description of health condition studied
elective cesarean
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
analgesia
Timepoint
Immediately after recovery admission then each 4 hours for 12 hours
Method of measurement
VAS(Visual Analage Scale)
Secondary outcomes
1
Description
mother`s pulse rate & blood pressure
Timepoint
each 5 minutes for the first 20 minutes,each 10 minutes till recovery discharge,each 4 hours for 12 hours
Method of measurement
physical exam & check list
2
Description
neonate`s APGAR score
Timepoint
first,fifth and tenth minutes
Method of measurement
check list
Intervention groups
1
Description
75-100 mg Intratechal Lidocaine 5%
Category
Treatment - Drugs
2
Description
75-100 mg Intratechal Lidocaine 5%+75 mcg Intratechal Clonidine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr. Afsaneh Norouzi
Street address
Emam Khomeiny street
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Saeed Changizi Ashtiyani
Street address
Alamhoda st.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak university of medical sciences
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
Arak University of Medical Sciences
Full name of responsible person
Afsaneh Norouzi
Position
Assistant professor,Anesthesiologist
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak
Postal code
Phone
+98 86122247900
Fax
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Afsaneh Norouzi
Position
Assistant professor,Anesthesiologist
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak
Postal code
Phone
+98 86122247900
Fax
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Saran Lotfollahzade
Position
Medical student
Other areas of specialty/work
Street address
Vaaliasr hospital
City
Arak
Postal code
Phone
+98 86122247900
Fax
Email
h23nn23h@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)