Comparing Effect of Gabapentin and Caffeine on Treatment of Headache Following Spinal Anesthesia in Women Candidate for Cesarean Section
Design
In this double-blind clinical trial, patients are assigned to the intervention and control groups by block random sampling.
Settings and conduct
Patients are not aware of the grouping and the study outcomes observed by a nurse who does not know the patient grouping and taking care of patients in the ward and recorded(outcomes) in the questionnaire. The site of this clinical trial is Besat Hospital in Sanandaj.
Participants/Inclusion and exclusion criteria
Being in level 1 and 2 of the ASA classification system,
Incidence of post dural puncture headache,
Elective cesarean section surgery,
Intervention groups
Intervention group 1: Administration of 300 mg of gabapentin orally every 12 hours for 3 days in patients after cesarean section with a history of post-dural puncture headache.
Intervention group 2: Administration of 100 mg of caffeine orally every 12 hours for 3 days in patients after cesarean section with a history of post-dural puncture headache.
Main outcome variables
Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210314050703N2
Registration date:2021-06-15, 1400/03/25
Registration timing:prospective
Last update:2021-06-15, 1400/03/25
Update count:0
Registration date
2021-06-15, 1400/03/25
Registrant information
Name
Negin Ghadami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3324 8519
Email address
ghadaminegin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Effect of Gabapentin and Caffeine on Treatment of Headache Following Spinal Anesthesia in Women Candidate for Cesarean Section
Public title
Comparing Effect of Gabapentin and Caffeine on Treatment of Headache Following Spinal Anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being in level 1 and 2 of the ASA classification system
Incidence of post dural puncture headache
Elective cesarean section surgery
Exclusion criteria:
History of co-existing diseases such as asthma, cardiovascular disease, diabetes.
History of caffeine or gabapentin allergy
Need for other painkillers (such as acetaminophen) during the study period
Preeclampsia and eclampsia
History of chronic headaches and migraines
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to one of the intervention and control groups by block randomization method.
In this method, how to randomize people to each of the intervention groups, the formation of 4 random blocks is used for randomization. The letter A is for group 1 (gabapentin) and the letter B is for group 2 (caffeine). The order of letters in each block is as follows. AABB, ABAB, ABBA, BBAA, BABA, BAAB
Patients are assigned to one of the study groups based on the letters in each randomly selected block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know which study groups they will be in.
Also, the nurse in the study provides the medication to the patients and is not aware of the patient's grouping. He/She also does not know which medication giving to the patient.
Medications are coded by a nurse who does not participate in the study and provides the medication to the prescribing nurse based on the code.
Also, the nurse who collects and records patient information does not know which group the patient belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St., Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.MUK.REC.1399.202
Health conditions studied
1
Description of health condition studied
Post dural puncture headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Headache
Timepoint
At intervals of 24, 48 and 72 hours after starting treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Administration of 300 mg capsule of gabapentin(Mehr Darou- Tehran- Iran) orally every 12 hours for 3 days in patients after cesarean section with a history of post-dural puncture headache.
Category
Treatment - Drugs
2
Description
Intervention group 2: Administration of 100 mg capsule of caffeine (Weider - Canada) orally every 12 hours for 3 days in patients after cesarean section with a history of post-dural puncture headache.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Negin Ghadami
Street address
Mardokh south Street- Keshavarz St.
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3328 5910
Email
besathospital@muk.ac.ir
Web page address
https://muk.ac.ir/Page?pageId=15
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3366 4351
Email
Research@muk.ac.ir
Web page address
https://research.muk.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Negin Ghadami
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bessat Hospital Keshavarz street
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3324 8519
Fax
Email
ghadaminegin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Negin Ghadami
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bessat Hospital Keshavarz street
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3324 8519
Fax
Email
ghadaminegin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Negin Ghadami
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bessat Hospital Keshavarz street
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3324 8519
Fax
Email
ghadaminegin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
Part of data on the primary outcomes will be shared.
When the data will become available and for how long
Six months after the publication of the results data access is possible.
To whom data/document is available
َAcademic researchers
Under which criteria data/document could be used
Meta-analysis is allowed.
From where data/document is obtainable
Dr. Negin Ghadami via Email: ghadaminegin@gmail.com
What processes are involved for a request to access data/document
Three months after the request, the data will be sent.