Evaluation of the effect of two types of Quincke and Whitaker needles on the incidence and severity of postdural puncture headache (PDPH) in women candidates for elective cesarean section under spinal block in Rafsanjan in 1399
Design
A clinical trial with a control group, two parallel groups, single-blind, randomized based on a random number table, and according to the number of patients entering the study was performed on 130 patients.
Settings and conduct
Field of work: Women candidates for elective cesarean section, Rafsanjan Women's Training Hospital. How to do: Follow up women after elective cesarean section for up to one week for the occurrence and severity of the postural headache and also evaluate accompanying symptoms such as shoulder pain, photophobia until one week after cesarean section, single blinding of participants
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women candidates for elective cesarean section under spinal anesthesia who have completed the informed consent form to participate in the study.
2. Age range 15 to 45 years
Exclusion criteria: 1- Women whose spinal anesthesia fails for the first time for any reason or partial anesthesia and we have to use analgesics and hypnotics to continue the operation.
2. Women taking anticoagulants or high blood pressure
Intervention groups
Intervention group 1: Quincke needle.
Intervention group 2: Whitaker needle.
Main outcome variables
Postdural puncture headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190817044544N2
Registration date:2022-01-13, 1400/10/23
Registration timing:retrospective
Last update:2022-01-13, 1400/10/23
Update count:0
Registration date
2022-01-13, 1400/10/23
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
2020-07-22, 1399/05/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
2020-07-22, 1399/05/01
Actual recruitment end date
2021-07-23, 1400/05/01
Trial completion date
empty
Scientific title
Assessment PDPH in women under elective cesarean section with two types of spinal needles
Public title
Postdural puncture headache
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Elective cesarean section women with ASA class1
Exclusion criteria:
Women candidates for emergency cesarean section and underlying disease
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
130
Actual sample size reached:
130
Randomization (investigator's opinion)
Randomized
Randomization description
First, using the excel file and random between function, 65 numbers were randomly selected from the numbers 1-130, which were assigned to the intervention group and the remaining numbers to the control group, then according to the number of women entering the study, the type of her group A (intervention) or B (control) was determined
Blinding (investigator's opinion)
Single blinded
Blinding description
For the participants in the study, the complication of postural puncture headache is explained and it said that two types of needles are used in this study, but each participant does not know the type of needle specifically.
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
Emam Ali Blvd., Main building of Medical sciences University
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.RUMS.REC.1399.041
Health conditions studied
1
Description of health condition studied
PDPH in elective cesarean surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of Postdural puncture headache
Timepoint
During the first 7 days after the intervention, the evaluation is performed every day
Method of measurement
In case of PDPH after spinal anesthesia, it is stated in the questionnaire form
Secondary outcomes
1
Description
severity of PDPH after spinal anesthesia
Timepoint
It is evaluated daily for seven days after cesarean section
Method of measurement
Visual analogue scale
2
Description
Days of PDPH
Timepoint
During seven days follow up after spinal block how many days PDPH occurs
Method of measurement
In case of this type of headache, complete the questionnaire on the number of days of PDPH
3
Description
If PDPH occurs after spinal anesthesia, it is necessary to take analgesic within seven days or not
Timepoint
During seven days follow up after spinal block,In case of PDPH، number of times the need for analgesic in total is evaluated
Method of measurement
The number of times the need for analgesic during seven days is recorded in the questionnaire
4
Description
there is restriction of movement in sleeping to sitting or sitting to standing
Timepoint
During seven days of follow up of PDPH
Method of measurement
The questionnaire completes the movement restriction section
5
Description
Is there associated symptoms and signs Includes neck pain, shoulder pain, nausea, sensitivity to sound, light
Timepoint
follow up during seven days after spinaL block
Method of measurement
In the questionnaire, the items are recorded in case of occurrence
Intervention groups
1
Description
Intervention group: Intervention group: Women under spinal anesthesia for elective cesarean section with Whitaker needle 25،needle insertion technique: Paramedin
Category
Other
2
Description
Control group: Women candidates for elective cesarean section under spinal anesthesia with Quincke 25 needle, Paramedin needle insertion technique
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ebn Abitaleb Hospital of Rafsanjan
Full name of responsible person
Fatemeh Jadidi
Street address
Ali-Ebn Abitaleb square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0027
Email
aliebn@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsi Zadeh
Street address
Emam Ali Blvd., Main building of Medical Sciences University
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 77 1793 3777
Email
info@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Fatemeh Jadidi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Ali Blvd., Khorasani Street, Hossaini Street, Alley 3th
City
Rafsanjan
Province
Kerman
Postal code
7717949921
Phone
+98 34 3428 6617
Email
fa.jadidi.2020@gmail.com
Person responsible for scientific inquiries
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
Emam Ali Blvd., Khorasani Street, Hossaini Street, Alley 3th
City
Rafsanjan
Province
Kerman
Postal code
7717949921
Phone
+98 34 3428 6617
Email
fa.jadidi.2020@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
Emam Ali Blvd., Khorasani Street, Hossaini Street, Alley 3th
City
Rafsanjan
Province
Kerman
Postal code
7717949921
Phone
+98 34 3428 6617
Email
fa.jadidi.2020@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Participants' personal data can be shared after not being identified
When the data will become available and for how long
Access period starts six months after the results are published
To whom data/document is available
Academic researchers and industry professionals can apply for the data
Under which criteria data/document could be used
In case of data reference, their use is unrestricted
From where data/document is obtainable
Rafsanjan University of Medical Sciences
What processes are involved for a request to access data/document
permission of vise chancellor of research and technology of RUMS