Comparing the effects of bupivacaine and ropivacaine on patients undergoing cesarean section in spinal anesthesia
Design
A double-blind randomized clinical trial with parallel groups and 60 patients (30 people in each group).
Settings and conduct
60 patients undergoing elective cesarean section with anesthesia risk (ASA I-II) in Imam Khomeini Hospital will be randomly divided into two groups of 30 patients: group1 receiving ropivacaine 1%( 15mg) and group 2 receiving hyperbaric bupivacaine 0.5% (10 mg). Spinal anesthesia will be performed in sitting position in the L3-L4 or L4-L5 space using the spinal needle. The patient's blood pressure will be measured every five minutes. Sensory and motor evaluation will be performed every 5 minutes in the first 32 minutes and then at 12-minute intervals until the end of surgery. The pain score of patients will be measured at the beginning and end of the surgery and at the time of discharge from the recovery room. Postoperative clinical complications of patients will be evaluated until 24 hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Term pregnancy (over 37 and less than 42 weeks), elective cesarean section, 20-40 years, weight between 65 and 95 kg, height between 155 and 175 cm, ASA Class I - II.
Exclusion criteria: Preterm and post term, abnormalities and problems of placenta or fetus, allergy to local anesthetics, spinal anesthesia contraindications.
Intervention groups
Patients were randomly divided into two groups receiving bupivacaine and ropivacaine. Group1: ropivacaine 1%( 15mg) was injected during surgery
Group2: hyperbaric bupivacaine 0.5% (10 mg)was injected during surgery.
Main outcome variables
Sensory and motor block duration; blood pressure; heart rate; pain score; postoperative clinical complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190529043751N1
Registration date:2019-07-08, 1398/04/17
Registration timing:registered_while_recruiting
Last update:2019-07-08, 1398/04/17
Update count:0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
Raziyeh Homayoon
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 1492
Email address
homayon_r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of bupivacaine and ropivacaine on the patients undergoing cesarean section in spinal anesthesia
Public title
Comparing the effects of bupivacaine and ropivacaine in the casarean section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term pregnancy (over 37 and less than 42 weeks)
Elective cesarean section
20-40 years
Weight between 65 and 95 kg
Height between 155 and 175 cm
ASA class I,II
Exclusion criteria:
Preterm and post term
Abnormalities and problems of placenta or fetus
Allergy to local anesthetics
Spinal anesthesia contraindications
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
By random block permutation, individuals will be randomly divided into two groups. The block sizes can be 4, 6 and so on. 6 blocks including 4 characters will be considered; AABB, ABAB, BBAA, BABA, ABBA, and BAAB. We will sample from the six blocks, with replacement to the extent that the sample size is completed. In this case, a sequence of letters will be obtained, in which individuals will be randomly divided into two equal groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
All medications will be in similar and dark pockets. A numeric label will be on each pack of medications. Patient and researcher will not inform of the number assigned to the relevant group. Then, according to the random sequence based on random block permutation, the packets of medications will be given to the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan Blvd., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.AJUMS.REC.1397.903
Health conditions studied
1
Description of health condition studied
cesarean
ICD-10 code
O74
ICD-10 code description
Complications of anesthesia during labor and delivery
Primary outcomes
1
Description
Motor block duration
Timepoint
Every 5 minutes in the first 32 minutes and then at 12-minute intervals until the end of surgery.
Method of measurement
Modified bromage scale
2
Description
ُSensory block duration
Timepoint
Every 5 minutes in the first 32 minutes and then at 12-minute intervals until the end of surgery.
Method of measurement
pin prick
Secondary outcomes
1
Description
Blood pressure
Timepoint
Every 5 minutes before injection until delivery and then every 15 minutes until discharge from the recovery room.
Method of measurement
Non-invasive Blood Pressure (NIBP)
2
Description
Heart rate
Timepoint
Every 5 minutes before injection until delivery and then every 15 minutes until discharge from the recovery room.
Method of measurement
ECG
3
Description
Analgesia
Timepoint
In the beginning and end of surgery and, when discharging from recovery room
Method of measurement
Visual analogues Scale
4
Description
Postoperative Clinical complications
Timepoint
Until 24 hours after discharge from the recovery room
Method of measurement
Examination
Intervention groups
1
Description
Ropivacaine group: Ropivacaine 1%( 15mg) ) (manufactured by Dei Fratelli Societa Di Eserciozio SpA C & Molteni L, Italy) will be injected during surgery.
Category
Treatment - Drugs
2
Description
Bupivacaine group: Hyperbaric bupivacaine 0.5% (10 mg)(manufactured by AstraZeneca, Sweden) will be injected during surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Raziyeh Homayoon
Street address
Imam Khomeini Hospital., Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2114
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Jundishapur University of Medical Sciences, Chancellor for Research and Technology Development, Golestan Blvd., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8286
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Raziyeh Homayoon
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2114
Email
raziyeh.homayoon@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2114
Email
akhoundzadeh-r@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Raziyeh Homayoon
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2114
Email
raziyeh.homayoon@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD