Comparison of the effect of intrathecal injection of pethidine, pethidine-bupivacaine and bupivacaine on pain severity and hemodynamic parameters after elective cesarean section
The aim of this study is to compare postoperative analgesia, hemodynamics and Apgar score of neonates in cesarean section patients under spinal anesthesia with pethidine, bupivacaine, and a combination of the two.
Design
In this double-blind randomized clinical trial, the rate of postoperative analgesia in 90 healthy women candidates for elective cesarean section with spinal anesthesia using pethidine, bupivacaine, and a combination of these two drugs will be evaluated. The method of data collection is using a questionnaire. Patients will be divided into 3 groups (30 patients in each).
Settings and conduct
In this double-blind clinical trial that will be performed in Vali Asr Hospital in Birjand, the rate of postoperative analgesia in healthy patients who are candidates for elective cesarean section with spinal anesthesia using pethidine, bupivacaine and a combination of these two drugs will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA 1 and ASA 2 from 20 to 40 years; No drug and smoking addiction; No history of hypertension, diabetes, and uncontrolled comorbidities; Elective cesarean section; No chronic pain; No mental disorder and hysteria
Exclusion criteria: Emergency cesarean section; Placental abruption; Placental accreta; Severe bleeding during surgery; Drug and smoking addiction; Uncontrolled comorbidities; Take painkillers or antiemetics 24 hours before surgery; Skin infection at the site of lumbar injection; Bupivacaine or pethidine allergy history; Intraoperative change of anesthesia type; Intraoperative Blood transfusion
Intervention groups
Healthy pregnant women aged 20 to 40 years undergo spinal anesthesia in three groups (one group with pethidine, the other group with bupivacaine and the last group with pethidine-bupivacaine mixture).
Main outcome variables
SBP
DBP
HR
Apgar score
Need for painkiller
PONV
Age
Itching
Shortness of breath
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200413047056N2
Registration date:2021-01-28, 1399/11/09
Registration timing:prospective
Last update:2021-01-28, 1399/11/09
Update count:0
Registration date
2021-01-28, 1399/11/09
Registrant information
Name
malihe zangoue
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 7036
Email address
mzangoue@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-31, 1399/11/12
Expected recruitment end date
2021-04-01, 1400/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intrathecal injection of pethidine, pethidine-bupivacaine and bupivacaine on pain severity and hemodynamic parameters after elective cesarean section
Public title
Comparison of pethidine and bupivacaine in spinal anesthesia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
ASA 1 and ASA 2 (patients with healthy or controlled mild disease) in the range of 20 to 40 years
No drug and smoking addiction
No history of hypertension, diabetes and uncontrolled comorbidities
Elective cesarean section
No chronic pain
No mental disorder and hysteria
Exclusion criteria:
Emergency cesarean section
Placental abruption
Placental accreta
Severe bleeding during surgery
Drug and smoking addiction
Uncontrolled comorbidities
Take painkillers or antiemetics 24 hours before operation
Skin infection at the site of lumbar injection
History of bupivacaine or pethidine allergy
Change ofanesthesia type during the operation
Blood transfusion during the operation
Age
From 20 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, a simple randomization method will be used. In this way 90 sealed envelopes, each containing a card of a different color and each color representing a group, will be placed in a box. After entering the operating room, if the patient has the inclusion criteria, she will pull one envelope out of the box and will be placed in the desired group according to the color of the card inside.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind clinical study, 90 sealed envelopes, each containing a card of a different color and each color representing a group, will be placed in a box. After entering the operating room, if the patient has the inclusion criteria, she will pull one envelope out of the box and will be placed in the desired group according to the color of the card inside, and then the drug will be prepared by an independent researcher (anesthesia technician).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.BUMS.REC.1398.144
Health conditions studied
1
Description of health condition studied
The rate of analgesia in cesarean section
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anesthesia during labor and delivery
Primary outcomes
1
Description
pain
Timepoint
Within 24 hours after the intervention
Method of measurement
Number of suppositories consumed
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Healthy pregnant women 20 to 40 years old undergoing spinal anesthesia with pethidine. After prepping and draping, spinal anesthesia with 100mg of pethidine will be performed using a 25 G Quincke needle in the L4-L5 or L5-S1 intervertebral space in a sitting position. After the injection, the patient is immediately returned to the supine position, and standard monitoring including continuous pulse oximetry and ECG will be used.
Category
Treatment - Drugs
2
Description
Intervention group 2: Healthy pregnant women 20 to 40 years old undergoing spinal anesthesia with bupivacaine. After prepping and draping, spinal anesthesia with 10mg of bupivacaine will be performed using a 25 G Quincke needle in the L4-L5 or L5-S1 intervertebral space in a sitting position. After the injection, the patient is immediately returned to the supine position, and standard monitoring including continuous pulse oximetry and ECG will be used.
Category
Treatment - Drugs
3
Description
Intervention group 3: Healthy pregnant women 20 to 40 years old undergoing spinal anesthesia with the pethidine-bupivacaine mixture. After prepping and draping, spinal anesthesia with 50mg of pethidine and 5mg of bupivacaine will be performed using a 25 G Quincke needle in the L4-L5 or L5-S1 intervertebral space in a sitting position. After the injection, the patient is immediately returned to the supine position, and standard monitoring including continuous pulse oximetry and ECG will be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital, Birjand
Full name of responsible person
Zahra Younesi
Street address
Ghaffari Ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
younesi13200@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tuba Kazemi
Street address
Ghaffari Ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Maliheh Zangoue
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaffari Ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
Mzangoue@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Amirs Saber Tanha
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaffari Ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
amirsaber63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zahra Younesi
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaffari Ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
younesi13200@gmail.com
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Total data after unidentifiable individuals
When the data will become available and for how long
One year after the results are published
To whom data/document is available
every one
Under which criteria data/document could be used
For research
From where data/document is obtainable
By Email with corresponding
What processes are involved for a request to access data/document