Comparison the effect of preincisional local infiltration of Lidocaine 2% and Marcaine 0/25% on severity of pain in patients after ceasarian section in ALZAHRA hospital in Rasht on 2011
The purpose of this study is to compare the effect of preincisional local infiltration of lidocaine 2% and marcaine0/25% on severity of pain in patients after ceasarian section in Alzahra hospital in rasht . After signing the informed consent , this double blind study, will be perfomed on 87 primiparum women with no history of drug reactions to anesthetics. The patients will randomly divided to 3 intervention groups with marcaine, lidocaine and control group , who will receive normal saline. If surgery prolonged more than 1 hour, or another surgery needed, the case will be excluded. The severity of pain in 1, 2, 3, 4, 8 and 12 hours after surgery will be assessed by visual analog scale, total dose of analgesic used and mean pain scale in the patient will be compare in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102131946N6
Registration date:2011-05-09, 1390/02/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-09, 1390/02/19
Registrant information
Name
Mandana Mansur Ghanaie
Name of organization / entity
Giulan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
m_m_ghanaie@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of preincisional local infiltration of Lidocaine 2% and Marcaine 0/25% on severity of pain in patients after ceasarian section in ALZAHRA hospital in Rasht on 2011
Public title
Comparison the effect of preincisional local infiltration of Lidocaine 2% and Marcaine 0/25% on severity of pain in patients after Ceasarian section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primiparity , Indications for spinal anesthesia .
Exclusion criteria: Surgery duration last more than 1 hour, need to another surgery , history of drug reaction to anesthetics, contraindications for spinal anesthesia .
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
87
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan Medical Science University
Street address
Melat st, Namjoo Ave
City
Rasht
Postal code
Approval date
2011-03-04, 1389/12/13
Ethics committee reference number
35
Health conditions studied
1
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O74.8
ICD-10 code description
Other complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
Pain after ceasarian section.
Timepoint
1, 2, 3, 4, 8 and 12 hours after surgery
Method of measurement
Visual Analog Pain Scale (VAS)
Secondary outcomes
1
Description
The mean score of pain after surgery
Timepoint
1, 2, 3, 4, 8 and 12 hours after surgery
Method of measurement
Visual Analog Pain Scale (VAS)
2
Description
The dose of analgesic used.
Timepoint
1, 2, 3, 4, 8 and 12 hours after surgery
Method of measurement
mg
3
Description
Time of the first dose of analgesics administration.
Timepoint
After surgery finished untile the first dose of analgesics
Method of measurement
Hours
4
Description
Patients mobilization time
Timepoint
After surgery finished untile the Patients mobilization time
Method of measurement
Hours
Intervention groups
1
Description
Single dose of 0.5 mg/kg of marcaine0.25% with 30cc volume will infiltrated in peritoneum, facia and muscle
Category
Treatment - Drugs
2
Description
Single dose of 4 mg/kg of lidocaine2% with 30cc volume will infiltrated in peritoneum, facia and muscle
Category
Treatment - Drugs
3
Description
Single dose of Normal saline with 30cc volume will infiltrated in peritoneum, facia and muscle
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital-Guilan University of Medical Sciences
Full name of responsible person
Street address
Alzahra hospital-Namjo street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Mellat St., Namjoo Ave.
City
Rasht
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, Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr. Mandana Mansour Ghanaie
Position
Obstetrics & Gynecologist
Other areas of specialty/work
Street address
Reproduction Health research center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
m_m_ghanaie@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Mandana Mansour Ghanaie
Position
Obstetrics & Gynecologist
Other areas of specialty/work
Street address
Reproductive health research center, Alzahra Hospital, Namjoo Avenue
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
m_m_ghanaie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Seyedeh Maryam Mousavi Chahardeh
Position
B.S
Other areas of specialty/work
Street address
Reproduction Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
+98 13 1322 2021
Email
h_fertility@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)