Investigation of the intrathecal fentanyl effect on post spinal anesthesia headache in patients undergoing elective cesarean section
Design
Double-blinded randomized clinical trial with block randomization, two parallel groups on 56 patients, phase III
Settings and conduct
Women between aged 15 and 35 years undergoing elective cesarean section under spinal anesthesia in Urmia Mahzad Hospital were included. In intervention group the spinal anesthesia will be performed using hyperbaric bupivacaine 0.5% (2.5 ml) and 25 micrograms of fentanyl (0.5 ml) and in the control group spinal anesthesia will be performed using only hyperbaric bupivacaine 0.5 % (2.5 ml).The patient and the person who will be assessed the outcomes (anesthesia assistant) will be blind about the intervention or control groups (Double-blined).
Participants/Inclusion and exclusion criteria
In this study, 56 patients undergoing elective cesarean section under spinal anesthesia with aged 15 to 35 years will be included. the exclusion criteria are Any contraindication for spinal anesthesia; A history of migraine or chronic headache ; Mental diseases; Neurological diseases; Epilepsy; Coagulation disorders; Drug abusers; and Eclampsia and preeclampsia during pregnancy.
Intervention groups
In intervention group the spinal anesthesia will be performed using hyperbaric bupivacaine 0.5% (2.5 ml) and 25 micrograms of fentanyl (0.5 ml) and in the control group spinal anesthesia will be performed using only hyperbaric bupivacaine 0.5 % (2.5 ml).
Main outcome variables
Frequency and severity of headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170515033986N3
Registration date:2022-01-30, 1400/11/10
Registration timing:registered_while_recruiting
Last update:2022-01-30, 1400/11/10
Update count:0
Registration date
2022-01-30, 1400/11/10
Registrant information
Name
Nazli Karami
Name of organization / entity
Urmia University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9932
Email address
karami.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the intrathecal fentanyl effect on post spinal anesthesia headache in patients undergoing elective cesarean section
Public title
The effect of fentanyl on headache after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women undergoing elective cesarean section under spinal anesthesia
Women aged 15 to 35 years
Patients with class ASA I and ASA II
Exclusion criteria:
Any contraindication for spinal anesthesia
A history of migraine or chronic headache
Mental diseases
Neurological diseases
Epilepsy
Coagulation disorders
Drug abusers
Eclampsia and preeclampsia during pregnancy
Age
From 15 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups using block randomization based on generated numbers by random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Current study is a double blind study. The patient and the person who will be assessed the outcomes (anesthesia assistant) will be blind about the intervention or control groups. therefore, the drugs will be prepared and coded by another anesthesiologist or anesthesia assistant, and the spinal anesthesia will be performed by anesthesia assistant (principal investigator).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-11-01, 1400/08/10
Ethics committee reference number
IR.UMSU.REC.1400.286
Health conditions studied
1
Description of health condition studied
Headache after cesarean section
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Frequency of headaches
Timepoint
In recovery, 6, 12 and 24 hours after surgery
Method of measurement
self-reporting
2
Description
The severity of the headache
Timepoint
In recovery, 6, 12 and 24 hours after surgery
Method of measurement
Verbal Rating Scale (VRS)
Secondary outcomes
1
Description
Mean arterial blood pressure
Timepoint
In recovery, 6, 12 and 24 hours after surgery
Method of measurement
Monitoring
2
Description
Heart rate
Timepoint
In recovery, 6, 12 and 24 hours after surgery
Method of measurement
Monitoring
Intervention groups
1
Description
Intervention group: The spinal anesthesia will be performed using hyperbaric bupivacaine 0.5% (2.5 ml) and 25 micrograms of fentanyl (0.5 ml). Fentanyl is a product of Caspian Pharmaceutical Company. Hyperbaric bupivacaine 0.5% is a product of the French pharmaceutical company, MYLAN S.A.S. The drugs are injected as a single dose.
Category
Treatment - Drugs
2
Description
Control group: The spinal anesthesia will be performed only using hyperbaric bupivacaine 0.5% (2.5 ml). No opioid will be used intrathecally. This drug is a product of the French pharmaceutical company, MYLAN S.A.S. The drug is injected as a single dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahzad hospital
Full name of responsible person
Dr. Nazli Karami
Street address
Mahzad hospital; Hassani Ave; Urmia; Iran
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
+98 44 3198 8293
Email
karami.n@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3222 2010
Email
mohebbi.i@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Nazli Karami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mahzad hospital, Hassani Ave., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
+98 44 3198 8293
Email
karami.n@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Nazli Karami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mahzad hospital; Hassani Ave; Urmia; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
+98 44 3198 8293
Email
karami.n@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Nazli Karami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mahzad hospital; Gassani Ave; Urmia; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
+98 44 3198 8293
Email
karami.n@umsu.ac.ir
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