Survey effect of Transnasal Sphenopalatin ganglion nerve block for treatment of postdural puncture headache after spinal anesthesia in cesarean section.
the effect of sphenopalatine ganglion block in treating PDPH following spinal anesthesia in cesarean section.
Design
The clinical trial has a control group, with parallel groups without blinding, randomized phase 3 through the random function of Excel software on 60 patients.
Settings and conduct
Pregnant women undergoing cesarean section with spinal anesthesia, who present with headache while standing after dura mater puncture at Nik Nafs and Ali Ibn Abi Talib (AS) maternity hospital in Rafsanjan, are performed using a numerical rating scale. Their headache is graded in terms of severity. In this way, based on the intensity of the pain, the patient is asked to give a score to the headache they are currently suffering from and this score is recorded. The first group (intervention), is the group receiving sphenopalatine ganglion block through The nose and the second group is the control group receiving drug treatment (pain reliever and serum).
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnant women undergoing cesarean section with spinal anesthesia who present with a headache after dural puncture.
Exclusion criteria include depression disorders, other mental disorders, history of drug or alcohol addiction, previous neurological headaches including migraine, nervous headache, etc., and previous brain defects and pre-eclampsia.
Intervention groups
the group receiving sphenopalatine ganglion block through the nose and the other group receiving pain analgesia and serum
Main outcome variables
Postural puncture headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190817044544N4
Registration date:2022-11-05, 1401/08/14
Registration timing:registered_while_recruiting
Last update:2022-11-05, 1401/08/14
Update count:0
Registration date
2022-11-05, 1401/08/14
Registrant information
Name
Fatemeh Jadidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0185
Email address
dr.fjadidi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-15, 1401/02/25
Expected recruitment end date
2022-11-16, 1401/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey effect of Transnasal Sphenopalatin ganglion nerve block for treatment of postdural puncture headache after spinal anesthesia in cesarean section.
Public title
Survey of PDPH through sphenopalatine ganglion block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women undergoing cesarean section are performed with spinal anesthesia who come with PDPH. At the beginning, headache characteristics (inclusion criteria) are examined, which include frontooccipital headache and positional headache.
Exclusion criteria:
It includes depression disorders, other mental disorders, history of drug or alcohol addiction, previous neurological headaches including migraines, neuralgia headaches, etc., and previous brain defects and pre-eclampsia.
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: First, by referring the samples to the pain clinic of Rafsanjan University of Medical Sciences, 60 cases are selected based on the entry and exit criteria, and then they are divided into two groups, intervention, and control groups. In this method, by merging the cards together ( cards shuffling), one card is removed and its assignment to the intervention or control group is recorded, and that card is removed from the other cards. Then the cards are merged again and another card is drawn. This process continues until reaching a random sequence corresponding to the sample size of 30 cases for the intervention group and 30 cases for the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of rafsanjan University of Medical Sciences
Street address
Rafsanjan, Imam Ali Boulevard
City
rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2022-05-14, 1401/02/24
Ethics committee reference number
IR.RUMS.REC.1401.031
Health conditions studied
1
Description of health condition studied
Postural puncture headache
ICD-10 code
O74.5
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during labour and delivery
Primary outcomes
1
Description
postural puncture headache
Timepoint
Before the intervention, one, six, 24 hours after the intervention
Method of measurement
Numerical rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group :Group receiving sphenoplatin ganglion block through the nose , In the patient lying down, two cc of 2% lidocaine are inserted into the middle turbinate of the nose using an applicator and the drug is discharged next to the sphenopalatine ganglion, then the patient remains in the same lying position for five minutes.
Category
Treatment - Drugs
2
Description
Control group: They receive drug treatment (analgesic and serum).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan University of Medical Sciences
Full name of responsible person
Saeid Khoram nia
Street address
Imam Ali Boulevard, Ali-Ibn Abi-Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
Email
saeed.khorramnia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vaziri Nejad
Street address
Emam Ali Blvd.
City
rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0086
Email
vcrt@rums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Saied Khoram Nia
Position
َAssistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Ali Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0086
Email
saeed.khorramnia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Saied Khoram Nia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Ali Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0086
Email
saeed.khorramnia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Jadidi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mofateh Blvd., Ali Ibn Abitaleb Hospital, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0185
Fax
Email
dr.fjadidi@rums.ac.ir
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in scientific centers
Under which criteria data/document could be used
Use of data for review studies
From where data/document is obtainable
Rafsanjan University of Medical Sciences
What processes are involved for a request to access data/document
Rafsanjan University of Medical Sciences, Research Assistant