Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000553178
Ethics application status
Approved
Date submitted
15/03/2019
Date registered
9/04/2019
Date last updated
9/04/2019
Date data sharing statement initially provided
9/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of the Needle's Direction Inserted From the Waist at Postoperative Headache
Scientific title
The Effect of The Spinal Needle's Direction to Dura Mater at Postoperative Headache After Spinal Anesthesia Applications
Secondary ID [1] 296611 0
Nil known
Universal Trial Number (UTN)
U1111-1223-9963
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cesarean section 310418 0
headache 310419 0
Condition category
Condition code
Surgery 309132 309132 0 0
Surgical techniques
Anaesthesiology 310654 310654 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before the operation,patient’s previous history of spinal anesthesia, current headache and low back pain data will be recorded . Patients will be placed in the sitting position according to routine spinal anesthesia protocol.
In this initiative; 25G Quincke tipped spinal needle used in the hospital Patients were grouped according to the cutting direction of the dura mater of the spinal needle ; sagittal (parallel to duramater fibers) and transverse (perpendicular to duramater fibers). Randomization was performed by a computer-generated scheme (computerized sequence generation). In both groups, 2 ml of .0.5% hyperbaric bupivacaine will be given intrathecally after the free flow of cerebrospinal fluid is observed. Patients's hemodynamic data (noninvasive systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, pulse, oxygen saturation) will be recorded before the operation and after the spinal anesthesia at 1st, 3rd, 5th, 7th, 10th,15th, 20th, 25th, 30th, 40th, 50th, 60th minute. After the intervention, the patients will be placed in the supine position and support will be placed on the back and hip area to be left lateral for 15 degrees. Sensory block will be evaluated with pinprick test and operation will start at T4-T6 level.
10 ml / kg of ringer lactate solution will be given to the patients before the operation. In case of a 20% or more decrease in arterial pressure compared to basal measurments during operation, 5-10 mg ephedrine intravenously will be given. In addition, the number of attempts for successful intervention will be recorded. Patients will be phoned by the investigators in terms of headache and other possible complications one week after the operation. Patients with headache will be evaluated according to VAS score.
Intervention code [1] 312917 0
Diagnosis / Prognosis
Comparator / control treatment
two groups: sagittal and transverse
Control group
Active

Outcomes
Primary outcome [1] 319454 0
postspinal puncture headache by using VAS (Visual Analog Scale) score
Timepoint [1] 319454 0
The patients will be questioned for the presence of headache complaints before the operation and will be questioned again a week after the operation.
Secondary outcome [1] 368249 0
Blood pressure values of the patients will be measured by the non-invasive method with the monitor in the anesthesia device and evaluated according to the basal values.
Timepoint [1] 368249 0
before the operation and after the spinal anesthesia at 1st, 3rd, 5th, 7th, 10th,15th, 20th, 25th, 30th, 40th, 50th, 60th minute
Secondary outcome [2] 368492 0
Heart rate values of patients will be evaluated according to basal measurements by monitoring electrocardiography and pulse oximetry
Timepoint [2] 368492 0
before the operation and after the spinal anesthesia at 1st, 3rd, 5th, 7th, 10th,15th, 20th, 25th, 30th, 40th, 50th, 60th minute

Eligibility
Key inclusion criteria
ASA 1-2
pregnant
cesarean/section
spinal anaesthesia
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
elder 40 years
emergancy cases
patients refusing spinal anaesthesia
conditions for contraindication for spinal anesthesia (incompatible, infection, hematological problems, preeclampsia, sendrom of increased intracranial pressure)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2019
Actual
Date of last participant enrolment
Anticipated
22/05/2019
Actual
Date of last data collection
Anticipated
29/05/2019
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 21346 0
Turkey
State/province [1] 21346 0
Sanliurfa

Funding & Sponsors
Funding source category [1] 301189 0
Hospital
Name [1] 301189 0
Sanliurfa Training and Research Hospital
Country [1] 301189 0
Turkey
Primary sponsor type
Individual
Name
MEHMET TERCAN
Address
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country
Turkey
Secondary sponsor category [1] 300811 0
Individual
Name [1] 300811 0
AHMET KAYA
Address [1] 300811 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country [1] 300811 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301929 0
Harran University medical faculty ethics committee
Ethics committee address [1] 301929 0
Ethics committee country [1] 301929 0
Turkey
Date submitted for ethics approval [1] 301929 0
22/10/2018
Approval date [1] 301929 0
05/11/2018
Ethics approval number [1] 301929 0
05/11/2018-11-03

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

Contacts
Principal investigator
Name 88594 0
Dr MEHMET TERCAN
Address 88594 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country 88594 0
Turkey
Phone 88594 0
+905323445635
Fax 88594 0
Email 88594 0
[email protected]
Contact person for public queries
Name 88595 0
MEHMET TERCAN
Address 88595 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country 88595 0
Turkey
Phone 88595 0
+905323445635
Fax 88595 0
Email 88595 0
[email protected]
Contact person for scientific queries
Name 88596 0
MEHMET TERCAN
Address 88596 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country 88596 0
Turkey
Phone 88596 0
+905323445635
Fax 88596 0
Email 88596 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.