A Comparison of the effects of 5% lidocaine and 5% meperidine plus 5% lidocaine on hypotension and duration of analgesia postoperative for cesarean section
This study was a Double-blind clinical trial that was to compare the effect combination of meperidine 5% + lidocaine 5% with single lidocaine 5% for spinal anesthesia in non emergency cesarean patients.
Inclusion criteria : Elective cesarean, previous cesarean, dystocia , full term pregnant women. Exclusion criteria: emergency cesarean, Preterm delivery. Sample size was determined 25 patients in each group.
The study groups included: Spinal anesthesia group 5% meperidine plus 5% lidocaine and other group 5% lidocaine Single. All patient received IV 15 ml/kg Ringers solution 15 minutes prior to block, and IV 10mg metoclopramide just before entering the O.R. Blood pressure Was measured before anesthesia and every five minutes during the operation to end the operation .spo2 Was measured by Pulse Oxy-meter. The time interval between injection of anesthetic and analgesic injections calculated were recorded as minute as the duration of analgesia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108286808N3
Registration date:2012-06-02, 1391/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-02, 1391/03/13
Registrant information
Name
Maryam Tolyat
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 9056
Email address
tolyatm@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Scienses
Expected recruitment start date
2008-09-05, 1387/06/15
Expected recruitment end date
2009-03-05, 1387/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the effects of 5% lidocaine and 5% meperidine plus 5% lidocaine on hypotension and duration of analgesia postoperative for cesarean section
Public title
A Comparison of the effects of 5% lidocaine and 5% meperidine plus 5% lidocaine on hypotension and duration of analgesia postoperative in cesarean section for spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Elective cesarean, previous cesarean, dystocia , full term pregnant women. Exclusion criteria: emergency cesarean, Preterm delivery.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Zahedan University of Medical Sciences
Street address
University of Medical Sciences-Pardis- Square Doctor Hesabi- Zahedan- Iran
City
Zahedan
Postal code
98167-43463
Approval date
2008-08-19, 1387/05/29
Ethics committee reference number
7247
Health conditions studied
1
Description of health condition studied
non-emergency caesarean
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
duration of post operative analgesia
Timepoint
Upon the occurrence of pain after surgery
Method of measurement
Pain recorded in form the precisely
2
Description
Hypotention
Timepoint
Prior to spinal anesthesia - Every 5 minutes during surgery until the end of surgery
Method of measurement
The mercury manometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: injection 5%meperidine1.25 mg/kg and 5% heavy lidocaine 60-75 mg for spinal anesthesia
Category
Treatment - Drugs
2
Description
Control group: injection 5% heavy lidocaine alone60-75 mg for spinal anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Street address
Zahedan University of Medical Sciences-Pardis- Square Doctor Hesabi- Zahedan- Iran
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Scienses
Full name of responsible person
mahdi Mohamadi
Street address
Zahedan University of Medical Sciences-Pardis- Square Doctor Hesabi- Zahedan- Iran
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Scienses
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
Birjand University of Medical Sciences
Full name of responsible person
Maryam Tolyat
Position
Msc
Other areas of specialty/work
Street address
Birjand University of Medical Sciences- Ghaffari Street- Birjand- South Khorasan-Iran
City
Birjand
Postal code
Phone
+98 56 1444 9056
Fax
Email
tolyatm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam tolyat
Position
Msc
Other areas of specialty/work
Street address
Birjand University of Medical Sciences- Ghaffari Street- Birjand- South Khorasan-Iran
City
Birjand
Postal code
Phone
+98 56 1444 9056
Fax
Email
tolyatm@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Tolyat
Position
Msc
Other areas of specialty/work
Street address
Birjand University of Medical Sciences- Ghaffari Street- Birjand- South Khorasan-Iran
City
Birjand
Postal code
Phone
+98 56 1444 9056
Fax
Email
tolyatm@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)