Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000523505
Ethics application status
Approved
Date submitted
6/03/2024
Date registered
26/04/2024
Date last updated
26/04/2024
Date data sharing statement initially provided
26/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Intraoperative Hemodynamic Changes on the Development of Postspinal Headache in Patients undergoing Cesarean Section with Spinal Anesthesia
Scientific title
The Relationship Between Postspinal Headache and Intraoperative Hemodynamic Changes After Cesarean Section Under Spinal Anesthesia
Secondary ID [1] 311686 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postspinal Headache 333389 0
Intraoperative Hemodynamic Changes 333390 0
Condition category
Condition code
Anaesthesiology 329847 329847 0 0
Other anaesthesiology
Reproductive Health and Childbirth 330077 330077 0 0
Childbirth and postnatal care
Anaesthesiology 330078 330078 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will undergo cesarean section under spinal anesthesia.Spinal anesthesia will be administered in sitting position under sterile conditions.25 G quincke needle will be preferred as spinal needle.12 mg bupivacaine heavy will be used as local anesthetic. Surgery will start when the anesthesia level is dermatome T4. During this time, the patient's routine monitoring will be recorded. blood pressure measurement will be before and after anesthesia and every 5 minutes. Any complications that may occur during the operation (nausea, vomiting, headache, chest pain, etc.) and medical drugs administered will be recorded. Patients will be followed up for complications for 1 week postoperatively.
Intervention code [1] 328148 0
Early Detection / Screening
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337616 0
Post-spinal headache rate
Timepoint [1] 337616 0
With in baseline ,postoperative 0, 1, 6, 12, 24 and 48 hours and 7th day
Primary outcome [2] 337834 0
Hemodynamic changes in the intraoperative
Timepoint [2] 337834 0
Before and after anesthesia and every 5 minutes during operation
Secondary outcome [1] 432535 0
Medications used for intraoperative and postoperative vomiting and hypotension
Timepoint [1] 432535 0
intraoperatively every five minutes and 0, 1, 6, 12, 24 and 48 hours in the postoperative period.

Eligibility
Key inclusion criteria
Patients undergoing cesarean section under spinal anesthesia. Aged 18-45 years with American Society of Anesthesiologist (ASA) physical classification score between ASA II- ASAIII
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with heart failure, neurological disorders, chronic headache, a condition that prevents the application of spinal anesthesia, or patients with inadequate block after spinal anesthesia will not be accepted into the study.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The present study is designed as a prospective observational study. The data collection time interval will be two months with an expected patient number of 400 patients. The data collected will be analysed with IBM SPSS package program. the results will be presented as means, madians, percentiles as applicable.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2024
Actual
Date of last participant enrolment
Anticipated
24/06/2024
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 26190 0
Turkey
State/province [1] 26190 0
Bursa

Funding & Sponsors
Funding source category [1] 316013 0
Self funded/Unfunded
Name [1] 316013 0
Serra Topal-Bursa City Hospital
Country [1] 316013 0
Turkey
Primary sponsor type
Individual
Name
Serra Topal-Bursa City Hospital
Address
Country
Turkey
Secondary sponsor category [1] 318164 0
None
Name [1] 318164 0
Address [1] 318164 0
Country [1] 318164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314838 0
Bursa City Hospital Clinical Research Ethics Committee
Ethics committee address [1] 314838 0
Bursa Sehir Hastanesi ,Doganköy, Doganköy Iç Yolu, 16110 Nilüfer/Bursa
Ethics committee country [1] 314838 0
Turkey
Date submitted for ethics approval [1] 314838 0
10/04/2023
Approval date [1] 314838 0
12/04/2023
Ethics approval number [1] 314838 0
2023-6/2

Summary
Brief summary
Hemodynamic changes that may occur during the operation in spinal anesthesia may be thought to impair cerebral blood circulation. In addition, the effects and side effects of drugs used during the operation may also affect cerebral blood circulation. In cesarean section operations performed under spinal anesthesia, conditions that change cerebral blood circulation may be thought to cause postoperative headache.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132882 0
Dr Serra TOPAL
Address 132882 0
Bursa Sehir Hastanesi,Doganköy, Doganköy Iç Yolu, 16110 Nilüfer/Bursa.
Country 132882 0
Turkey
Phone 132882 0
+905068823855
Fax 132882 0
Email 132882 0
dr.serra@msn.com
Contact person for public queries
Name 132883 0
Serra TOPAL
Address 132883 0
Bursa Sehir Hastanesi,Doganköy, Doganköy Iç Yolu, 16110 Nilüfer/Bursa.
Country 132883 0
Turkey
Phone 132883 0
+905068823855
Fax 132883 0
Email 132883 0
dr.serra@msn.com
Contact person for scientific queries
Name 132884 0
Serra TOPAL
Address 132884 0
Bursa Sehir Hastanesi,Doganköy, Doganköy Iç Yolu, 16110 Nilüfer/Bursa.
Country 132884 0
Turkey
Phone 132884 0
+905068823855
Fax 132884 0
Email 132884 0
dr.serra@msn.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to regional laws regarding the 'personal data protection' in Turkey.


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.