Determining the pregabalin effects on post-dural puncture headache after spinal anesthesia in elective cesarean surgery.
Design
The double-blind, randomized clinical trial with parallel designs
The study was performed on 68 patients in two groups. The randomization method is permuted block randomization.
Settings and conduct
This study was performed in Urmia Shahid Motahari Hospital to assess the effect of pregabalin on reducing the incidence and severity of headache after Dora puncture as a double-blind clinical trial. It should be noted that the patients and their parents were unaware of being in the intervention groups and the clinical evaluator was unaware of the placement of patients in the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women candidate for elective cesarean surgery with ASA1 and ASA2, obtaining informed consent.
Exclusion criteria: Having a history of migraine - the patient with ASA 3 and above, the patients with indications for emergency cesarean section, previous history of post-dural puncture headache, prohibitions of spinal anesthesia for patients who are unable to cooperate will also be excluded from the study.
Intervention groups
The pregnant women who were candidates for elective cesarean section were prescribed 150 mg pregabalin capsule 90 minutes before preparation for surgery.Control group receive placebo.
Main outcome variables
Post-dural puncture headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033992N4
Registration date:2020-12-26, 1399/10/06
Registration timing:retrospective
Last update:2020-12-26, 1399/10/06
Update count:0
Registration date
2020-12-26, 1399/10/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 2010
Email address
karami.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-16, 1398/09/25
Expected recruitment end date
2020-05-14, 1399/02/25
Actual recruitment start date
2019-12-16, 1398/09/25
Actual recruitment end date
2020-05-14, 1399/02/25
Trial completion date
2020-07-20, 1399/04/30
Scientific title
Assessment of Pregabalin Effects on Post-Dural Puncture Headache After Spinal Anesthesia in Elective Cesarean Surgery.
Public title
The effect of pregabalin on post dural puncture headache.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women who undergo elective cesarean section
American Society of Anesthesiologists (ASA) 1 and 2
Exclusion criteria:
Having a history of migraine
The patient with ASA 3 and above
The patients with indications for emergency cesarean section
Previous history of post-dural puncture headache
Prohibitions of spinal anesthesia for patients who are unable to cooperate
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
136
Actual sample size reached:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be conducted based on the permuted block randomization method. We will have 34 blocks of 4 letters in which every block contains 2 A and 2 B e.g. ABAB. Each block will have four capacities. Then, in each block, subjects will be randomly assigned to intervention (n=68) or placebo (n=68) groups. Random assignment will be done using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients in the study are behind the investigator and the statistical analyzer is unaware of how the groups are allocated.
Placebo
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
No. 30, Jahad Sq., Resalat St., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Approval date
2019-12-14, 1398/09/23
Ethics committee reference number
IR.UMSU.REC. 1398.341
Health conditions studied
1
Description of health condition studied
Headach
ICD-10 code
R51
ICD-10 code description
Headache
Primary outcomes
1
Description
Severity of headach
Timepoint
Evaluation of the incidence and Severity of post-dural puncture headache in the interval of 6,12, 24, 48, 72 hours after spinal anesthesia
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
post-dural puncture headache
Timepoint
6,12, 24, 48, 72 hours after spinal anesthesia
Method of measurement
Visual analog scale
2
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: pregnant women, candidates for elective cesarean section were prescribed 150 mg pregabalin capsule made by Pfizer 90 minutes before preparation for surgery.
Category
Treatment - Drugs
2
Description
Control group: pregnant women, candidates for elective cesarean section were prescribed placebo capsule 90 minutes before preparation for surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Shahid Motahari University Hospital
Full name of responsible person
Tohid Karami
Street address
No. 30, Jahad Sq., Resalat St., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3348 9752
Email
karami.tohid@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
No. 30, Jahad Sq., Resalat St., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7224
Email
mohebbi_iraj@yahoo.co.uk
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
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No. 30, Jahad Sq., Resalat st., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Email
karami.tohid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No. 30, Jahad Sq., Resalat st., Urmia University of Medical Sciences, Urmia, Iran
City
Uremia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Email
karami.tohid@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No. 30, Jahad Sq., Resalat st., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Email
karami.tohid@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
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
Individual data will be confidential and the results of the study will be published as an article.
When the data will become available and for how long
2020
To whom data/document is available
The article will be published internationally.
Under which criteria data/document could be used
There is no special condition.
From where data/document is obtainable
Internet
What processes are involved for a request to access data/document