Comparison of the effect of Bupivacaine 0.5% , Lidocaine 5% , Pethidine , Lidocaine 5% & intratecal on the incidence of decrease blood pressure , nausea and vometing for elective caesarean section
To compare the effect of Bupivacaine 0.5% and Lidocaine 5% - Pethedine and Lidocaine 5% intrathecal on the incidence of hypotension and nausea and vomiting during cesarean section
Design
Randomised single blind clinical trial, parallel groups trial. Randomisation was centralised and computerised
Settings and conduct
Methods: Patients will be divided into three groups of 25 people and spinal anesthesia will be performed for them.
Local anesthetic in group one is: Lidocaine 5% - Pethedine (60 mg Lidocaine 5% -15 mg Pethedine), in group 2: 75 mg Lidocaine 5% and in group three: 15 Bupivacaine 0.5 % .
Place of study:Gerash Amir-al-Momenin medical and educational center
Participants/Inclusion and exclusion criteria
Study population: 75 women undergoing cesarean section.
Inclusion criteria: term pregnancy (42-37 weeks); willingness to participate in the study; NPO; ASA I; elective caesarean section.
Exclusion criteria: operation duration more than 80 minutes; using beta tocolytic, fetal abnormalities ; pregnancy complications ; failure in performing spinal; low level of blocks; stomachache; metabolic diseases, hypertension; nausea and vomiting before surgery; any underlying diseases; complications during surgery; arterial or venous disease in lower extremities; defects in the immune system and gestational diabetes, smoking, alcoholism and opium addiction, malnutrition; anemia.
Intervention groups
group one : Lidocaine 5% - Pethedine (60 mg Lidocaine 5% -15 mg Pethedine) intratecal
group 2 : 75 mg Lidocaine 5% intratecal
group 3 : 15 Bupivacaine 0.5 % intratecal
Main outcome variables
pulse rate, mean, systolic and diastolic blood pressure will be measured and recorded immediately after the block every 3 minutes and then every 15 minutes until the end of the recovery.
The incidence of itching, nausea and vomiting during surgery and recovery will be measured and recorded.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033491N2
Registration date:2018-08-09, 1397/05/18
Registration timing:retrospective
Last update:2018-08-09, 1397/05/18
Update count:0
Registration date
2018-08-09, 1397/05/18
Registrant information
Name
Jalal Saem
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 713634001
Email address
saemj@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic Chancellor for Research, Gerash University of Medical Sciences
Expected recruitment start date
2017-10-04, 1396/07/12
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Bupivacaine 0.5% , Lidocaine 5% , Pethidine , Lidocaine 5% & intratecal on the incidence of decrease blood pressure , nausea and vometing for elective caesarean section
Public title
Study the effect of Bupivacaine 0.5% , Lidocaine 5%, Pethidine , Lidocaine 5% & intratecal on the incidence of decrease blood pressure, nausea and vomiting for elective caesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45 - 18 years
Term pregnancy (42-37 weeks)
Willingness to participate in the study
NPO (Nil Per Os)
ASA I
Elective caesarean section
Exclusion criteria:
Operation duration more than 80 minutes
Using ritodrine or other beta tocolytic
Fetal abnormalities or pregnancy complications
Failure in performing spinal
Low level of blocks (block level lower than T8)
Stomachache; metabolic diseases; hypertension; nausea and vomiting before surgery
Any underlying diseases
Complications during surgery
Arterial or venous disease in lower extremities
Defects in the immune system and gestational diabetes
Smoking
Alcoholism and opium addiction
Malnutrition
Anemi
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple allocation by Statistical software
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients will be blind to the kind of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gerash University of Medical Sciences
Street address
Gerash University of Medical sciences, Student Blv, Imam Hussain (AS) Blv, Gerash, Fars Province, Iran
City
Gerash
Province
Fars
Postal code
58666 – 74417
Approval date
2017-10-02, 1396/07/10
Ethics committee reference number
IR.GERUMS.REC.1396.1032
Health conditions studied
1
Description of health condition studied
Caesarean Section
ICD-10 code
O.82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Percentage of people who have nausea and vomiting during surgery
Timepoint
During surgery and then until the end of the recovery
Method of measurement
Observasion
2
Description
Blood Pressure
Timepoint
Measure and record pulse rate, mean, systolic and diastolic blood pressure immediately after the block (during surgery) every 3 to 15 minutes and then every 5 minutes until the end of the recovery
Method of measurement
Automatic sphygmomanometer
Secondary outcomes
1
Description
Itching
Timepoint
Every 3 to 15 minutes and then every 5 minutes until the end of the recovery
Method of measurement
Observasion
Intervention groups
1
Description
Patients in group one received lidocaine 5% - pethedine (60 mg lidocaine 5% -15 mg pethedine as local anesthetic.
Category
Treatment - Drugs
2
Description
Patients in group two received 75 mg lidocaine 5% as local anesthetic.
Category
Treatment - Drugs
3
Description
Patients in group three received 15 bupivacaine 0.5 % as local anesthetic.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Jalal Saem
Street address
Gerash University of Medical sciences, Student Blv, Imam Hussain (AS) Blv, Gerash, Fars Province, Iran
City
Gerash
Province
Fars
Postal code
58666 – 74417
Phone
+98 71 5244 2002
Email
saemj@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gerash University of Medical Sciences
Full name of responsible person
Dr Mehdi Mohsenzadeh
Street address
Gerash University of Medical sciences, Student Blv, Imam Hussain (AS) Blv, Gerash, Fars Province, Iran
City
Gerash
Province
Fars
Postal code
۵۸۶۶۶ – ۷۴۴۱۷
Phone
+98 71 5245 2339
Email
saemj@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gerash University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gerash University of Medical Sciences
Full name of responsible person
Jalal Saem
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Gerash University of Medical sciences, Student Blv, Imam Hussain (AS) Blv, Gerash, Fars Province, Iran
City
Gerash
Province
Fars
Postal code
58666 – 74417
Phone
+98 71 5244 8108
Fax
Email
saemj@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gerash University of Medical Sciences
Full name of responsible person
Jalal Saem
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Gerash University of Medical sciences, Student Blv, Imam Hussain (AS) Blv, Gerash, Fars Province, Iran
City
Gerash
Province
Fars
Postal code
58666 – 74417
Phone
+98 71 5244 8108
Fax
Email
saemj@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gerash University of Medical Sciences
Full name of responsible person
Jalal Saem
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Gerash University of Medical sciences, Student Blv, Imam Hussain (AS) Blv, Gerash, Fars Province, Iran
City
Gerash
Province
Fars
Postal code
58666 – 74417
Phone
+98 71 5244 8108
Fax
Email
saemj@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data will be coded without the names of the participants.
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
The published article for this study will be accessible to everyone, but other information will only be available to the sponsoring organization.
Under which criteria data/document could be used
The published paper for this study will be accessible to everyone, but other information will only be available to the sponsoring organization
From where data/document is obtainable
Visit the Research Deputy of the Gerash University of Medical Sciences.
What processes are involved for a request to access data/document
Visit the Research Deputy of the University of Medical Sciences. The vice chancellor will refer the applicant to the researcher if the applicant agrees.