Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000572561
Ethics application status
Approved
Date submitted
24/01/2024
Date registered
6/05/2024
Date last updated
24/11/2024
Date data sharing statement initially provided
6/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of small gauge spinal needle on post Dural puncture headache after spinal anesthesia in elective caesarian section.
Scientific title
Efficacy and safety of 27G vs 25G Quincke spinal needle on post Dural puncture headache after spinal anesthesia in patients undergoing elective caesarean section.
Secondary ID [1] 311391 0
nil known
Universal Trial Number (UTN)
u1111-1303-1245
Trial acronym
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Post Dural puncture headache. 332670 0
Spinal Anesthesia complications. 332671 0
Elective Caesarian Section. 333217 0
Condition category
Condition code
Anaesthesiology 329377 329377 0 0
Pain management
Mental Health 329906 329906 0 0
Anxiety
Infection 329907 329907 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the procedure all ethical and hospital protocols will be followed. After proper counselling, preparation and monitoring according to local protocols, an injection of 3ml of lidocaine 2% local anesthetic will be given at injection site five minutes before spinal anesthesia.
Patients with ASA 2 classification for elective caesarian section are divided into two groups ;Group A (Intervention Group) will receive spinal anesthesia with 27G Quincke needle for elective caesarian section and group B (Comparator group) will receive spinal anesthesia with 25G Quincke needle for elective caesarian section by a consultant anesthetist, around fifteen minutes prior to surgery. Patients will be observed for Post Dural Puncture headache for the next 72 hours.
Intervention code [1] 327838 0
Treatment: Devices
Comparator / control treatment
Group B, ASA-2 classified patients who will receive spinal anesthesia with 25G Quincke needle for elective Caesarean section.
Control group
Active

Outcomes
Primary outcome [1] 337200 0
Incidence of Post Dural Puncture Headache (PDPH) with 27G Quincke needle in elective caesarian section
Timepoint [1] 337200 0
72 hours, starting from the time of spinal anesthesia procedure.
Secondary outcome [1] 431040 0
Stay time in hospital, primarily due to Post Dural Puncture Headache.
Timepoint [1] 431040 0
96 hours after spinal anesthesia for elective caesarian section.
Secondary outcome [2] 432792 0
Anxiety
Timepoint [2] 432792 0
96 hours after spinal anesthesia for elective caesarian section.

Eligibility
Key inclusion criteria
All ASA 2 elective caesarian sections admitted through Out patient department in designated hospital who consented and have no contraindications to spinal anesthesia and consented for this study.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.ASA 3 and 4 patients for elective caesarian section.
2..Emergency caesarian sections.
3.Those who have history of Post Dural puncture headache, migraine or any other space occupying lesions associated with headache.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization as according to computer admission number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All eligible patients will be randomly divided into two groups according to computer generated lists.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
all data will be stored and analyzed in SPSS version 23.0. Mean + SD will be calculated for quantitative variables like age ,BMI, Gravity ,parity and number of attempts. Frequency and percentages will be calculated for categorical like PDPH. PDPH will be stratified among age ,BMI, Gravity, parity and number of attempts to see the effect modification using chi square test with p value of 0.5as significant. all results will be presented in the form of tables and graphs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/06/2024
Actual
13/05/2024
Date of last participant enrolment
Anticipated
2/09/2024
Actual
30/08/2024
Date of last data collection
Anticipated
9/09/2024
Actual
2/09/2024
Sample size
Target
218
Accrual to date
Final
207
Recruitment outside Australia
Country [1] 26100 0
Pakistan
State/province [1] 26100 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 315651 0
Hospital
Name [1] 315651 0
Khyber Medical College
Country [1] 315651 0
Pakistan
Primary sponsor type
Hospital
Name
Khyber Medical College
Address
Khyber Medical College, Khyber Teaching Hospital, Main University Road, Peshawar
Country
Pakistan
Secondary sponsor category [1] 317752 0
None
Name [1] 317752 0
Address [1] 317752 0
Country [1] 317752 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314535 0
Khyber Medical College Institutional Research and Ethical Review Board
Ethics committee address [1] 314535 0
Ethics committee country [1] 314535 0
Pakistan
Date submitted for ethics approval [1] 314535 0
30/11/2023
Approval date [1] 314535 0
14/12/2023
Ethics approval number [1] 314535 0
801/DME/KMC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131926 0
A/Prof Fazal wadood
Address 131926 0
Flat 12, Doctors Flats, Street No.1, Khyber Teaching Hospital, Main University Road, Peshawar, Khyber Pakhtunkhwa 25120 Pakistan
Country 131926 0
Pakistan
Phone 131926 0
+923009595074
Fax 131926 0
Email 131926 0
fazal.wadood@kmc.edu.pk
Contact person for public queries
Name 131927 0
Fazal wadood
Address 131927 0
Flat 12, Doctors Flats, Street No.1, Khyber Teaching Hospital, Main University Road, Peshawar, Khyber Pakhtunkhwa 25120 Pakistan
Country 131927 0
Pakistan
Phone 131927 0
+923009595074
Fax 131927 0
Email 131927 0
fazal.wadood@kmc.edu.pk
Contact person for scientific queries
Name 131928 0
Syed Osama Farooq
Address 131928 0
Room No 9, Old Doctors Hostel, Gate 2, Khyber Teaching Hospital, Main University Road, Peshawar, Khyber Pakhtunkhwa 25120 Pakistan
Country 131928 0
Pakistan
Phone 131928 0
+923339149561
Fax 131928 0
Email 131928 0
osama.farooq@kth.edu.pk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
1.Baseline Assessments and inclusion exclusion criteria .
2.Visual analogue scale of all patients.
3.Randomization of groups
When will data be available (start and end dates)?
13/05/2024 till 02/09/2024
Available to whom?
1.Original researchers
2.instituational Research board.
3.Trial registry.
Available for what types of analyses?
1.Original Research
2.Meta analysis /systemic review.
How or where can data be obtained?
Email the corresponding author
fazal.wadood@kmc.edu.pk


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21478Study protocol  fazal.wadood@kmc.edu.pk
21479Ethical approval  fazal.wadood@kmc.edu.pk
21480Informed consent form  fazal.wadood@kmc.edu.pk



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.