Comparison of the effect of Fentanyl and Sufentanil added to intrathecal Bupivacaine on post operative pain after elective cesarean section in pregnant women
The current study was a prospective double blind randomized clinical trial, phase 2, one center. The study population was comprised of pregnant women who were candidates for elective cesarean section and had signed written consent. Sampling in this study was based on inclusion and exclusion criteria. The Randomization was done using random number table. The person who assessed the patients and patient who accepted to be put under treatment were blind to the group allocation. Patients in one group received 10 mg bupivacaine 0.5% plus 25 mg fentanyl while Patients in other group received 10 mg of 0.5% bupivacaine plus 5 µg of sufentanil through injection in to the cerebrospinal fluid using a 5 cc syringe, at the intrathecal space in a completely sterile condition. Inclusion criteria included all pregnant women classified as class І or П of ASA (American Society of Anesthesiologists) who were candidate for elective cesarean section. Exclusion criteria: pregnant women who were not satisfied with spinal anesthesia. Primary outcome measures were included anesthesia level, blood pressure, analgesia level and secondary outcome measures were nausea and vomiting
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101530303N1
Registration date:2017-03-21, 1396/01/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-21, 1396/01/01
Registrant information
Name
Abbas Paknahad
Name of organization / entity
Hormozgan University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 71 5344 2196
Email address
apnabbas68@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hormozgan University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Fentanyl and Sufentanil added to intrathecal Bupivacaine on post operative pain after elective cesarean section in pregnant women
Public title
Comparison of the effect of Fentanyl and Sufentanil added to Bupivacaine on post-cesarean pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: class І or П of ASA (American Society of Anesthesiologists; candidate for elective cesarean section; no history of heart disease, hypertension, preeclampsia, gestational diabetes; being satisfied to receive intrathecal anesthesia and participate in the study. Exclusion criteria: contraindication for spinal anesthesia; presence of infection in the needle insertion site; high intracranial pressure; coagulopathy; platelet count lower than 75000.
Age
From 10 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization has been done using random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences, Bandar Abbas.
Street address
Shahid Mohammadi Hospital, Bandar Abbas.
City
Bandar Abbas
Postal code
7468178978
Approval date
2015-06-06, 1394/03/16
Ethics committee reference number
HUMS.REC.1394.163
Health conditions studied
1
Description of health condition studied
Pain after cesarean section
ICD-10 code
080-084
ICD-10 code description
Delivery
Primary outcomes
1
Description
The numbness
Timepoint
3 times (every 8 hours) in the first 24 hours.
Method of measurement
Questionnaire
2
Description
Blood Pressure
Timepoint
Monitoring during the first 24 hours.
Method of measurement
Questionnaire
3
Description
Analgesia
Timepoint
3 times (every 8 hours) in the first 24 hours.
Method of measurement
Questionnaire
Secondary outcomes
1
Description
nausea and vomiting
Timepoint
3 times (every 8 hours) in the first 24 hours.
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: 10 mg of 0.5% bupivacaine with 25 micrograms of fentanyl prescribed intrathecally into cerebrospinal fluid, at the space between the vertebrae 4 and 5 lumbar in the midline, using a syringe 5 cc in sterile condition under the supervision of an anesthesiologist.
Category
Other
2
Description
Intervention group 2: 10 mg of 0.5% bupivacaine with 25 micrograms of sufentanil prescribed intrathecally into cerebrospinal fluid, at the space between the vertebrae 4 and 5 lumbar in the midline, using a syringe 5 cc in sterile condition under the supervision of an anesthesiologist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Abbas Pak Nahad
Street address
Shariati hospital, Farhangian street, Bandar Abbas
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hormozgan University of Medical Sciences, Bandar Abbas.
Full name of responsible person
Abbas Pak Nahad, Dr. Manoochehr Kamali
Street address
Hormozgan University of Medical Sciences, Dabbaghian street, Bandar Abbas
City
Bandar Abbas
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 of Hormozgan University of Medical Sciences, Bandar Abbas.
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
Anaesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical
Full name of responsible person
Abbas Pak Nahad
Position
BSc
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Dabbaghian street, Bandar Abbas
City
Bandar Abbas
Postal code
7468178972
Phone
+98 71 5344 2196
Fax
Email
apnabbas68@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anaesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical
Full name of responsible person
Abbas Pak Nahad
Position
BSc
Other areas of specialty/work
Street address
Hormozgan University of Medical Sciences, Dabbaghian street, Bandar Abbas
City
Bandar Abbas
Postal code
7468178978
Phone
+98 71 5344 2196
Fax
Email
apnabbas68@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas.
Full name of responsible person
Maryam Sharafi
Position
BSc
Other areas of specialty/work
Street address
Hormozgan University of Medical Sciences, Farmandari street, Bandar Abbas
City
Bandar Abbas
Postal code
7468178970
Phone
+98 987633332196
Fax
Email
mr.shararfi.74@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)