Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000578202
Ethics application status
Approved
Date submitted
6/03/2018
Date registered
16/04/2018
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Correlation of actual epidural depth with ultrasonographic measurements at transverse plane and sagittal paramedian oblique plane in parturients undergoing elective cesarean section with combined spinal epidural anesthesia
Scientific title
Correlation of actual epidural depth with ultrasonographic measurements at transverse plane and sagittal paramedian oblique plane in parturients undergoing elective cesarean section with combined spinal epidural anesthesia
Secondary ID [1] 294241 0
none
Universal Trial Number (UTN)
U1111-1210-3274
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
combined spinal epidural anesthesia 306918 0
cesarean section 306919 0
Condition category
Condition code
Anaesthesiology 306013 306013 0 0
Other anaesthesiology
Surgery 306014 306014 0 0
Other surgery
Musculoskeletal 306015 306015 0 0
Normal musculoskeletal and cartilage development and function
Reproductive Health and Childbirth 306016 306016 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The measurements will be done at the operation room after monitorization of the parturient in accordance with the standards of American Society of Anesthesiologists. Patient will be placed at sitting position on the operation table and ultrasonography will be done at this position which will also be the position for combined spinal epidural anesthesia. An anesthesiologist experienced in sonoanatomy will do the ultrasonographic examination of epidural space in both transverse and sagittal paramedian oblique plane. The depth of epidural space in both examinations will be recorded. While performing combined spinal epidural anesthesia, after aseptic preparing the skin and infiltration of entry site for epidural needle with local anesthetic drug, epidural needle will be introduced from skin through epidural space with loss of resistance technique. At the point epidural space is reached, epidural needle will be marked with a sterile permenant marker and after introducing spinal needle through epidural needle, free flow of cerebrospinal fluid will be observed, spinal needle will be locked within the epidural needle and 2ml 0.5% hyperbaric bupivacaine will be injected. The distance between the tip of epidural needle and the spinal needle will be measured. The actual depth of epidural space will be measured as the distance marked on the epidural needle to its tip. The depth of subarachnoid space will be accepted as the distance between the tip of spinal needle and the tip of epidural needle plus the measured actual epidural depth which was formerly defined.
Intervention code [1] 300535 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305048 0
One of the composite outcomes of the study is determination of epidural depth at transverse plane and sagittal paramedian oblique plane with ultrasound in parturients undergoing elective cesarean section with combined spinal epidural anesthesia.
Timepoint [1] 305048 0
following the acceptance of parturient into the operation room, just before the cesarean section.
Primary outcome [2] 305049 0
determination of actual epidural depth with measuring the epidural and spinal needle lengths introduced from the skin to the epidural and subarachnoid spaces.
Timepoint [2] 305049 0
after administration of combined spinal epidural anesthesia just before cesarean section.
Primary outcome [3] 305050 0
Another composite outcome of the study is determining the correlation between actual epidural depth and epidural depth measured with ultrasound at transverse plane and sagittal paramedian oblique plane. Actual epidural depth is measured as follows: Epidural needle is inserted with loss of resistance to air technique and when epidural space is located a permenant marker is used to mark the length of epidural needle at the level of patient's skin. The distance between the marked point on the epidural neddle to the tip of epidural needle is accepted as actual epidural depth.
Timepoint [3] 305050 0
following the acceptance of parturient to operation room, just before the start of cesarean section.
Secondary outcome [1] 345339 0
A composite secondary outcome is determining the correlation between parturients' BMI and the epidural depth measurements with ultrasound at transverse and sagittal paramedian oblique planes.
Timepoint [1] 345339 0
following the acceptance of parturient into the operation room, just before the cesarean section.

Eligibility
Key inclusion criteria
parturients undergoing elective cesarean section with combined spinal epidural anesthesia
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
multiple and/or complicated pregnancies, eclampsia, preeclampsia, American society of anesthesiologists physical risk score >II, Any contraindication for combined spinal epidural anesthesia, coagulopathy and/or anticoagulant drug use , patient refusal to participate to study, and emergency cases.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
IBM SPSS ver 21.0 will be used to analyze the data collected. mean, standard deviation, frequencies, median will be used for the analysis of quantitative data. normal distribution of data will be analyzed by Kolmogorov- Smirnow and Shapiro Wilk tests. Spearman's rho correlation and Pearson correlation tests will be used to analyze the correlation between the actual epidural depth and the epidural depth measured with ultrasound at saggital paramedian oblique plane and transverse plane. Bland altman plot will also be used to compare the epidural depth measurements.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2018
Actual
2/06/2018
Date of last participant enrolment
Anticipated
Actual
28/09/2018
Date of last data collection
Anticipated
Actual
28/09/2018
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 9649 0
Turkey
State/province [1] 9649 0
kirsehir

Funding & Sponsors
Funding source category [1] 298880 0
Hospital
Name [1] 298880 0
hi evran university training and research hospital
Country [1] 298880 0
Turkey
Primary sponsor type
Individual
Name
mehmet cantürk
Address
ahi evran university training and research hospital
address: kervansaray mahallesi 2019.sokak no:1
merkez/kirsehir/turkey
p.k.40100
Country
Turkey
Secondary sponsor category [1] 298093 0
None
Name [1] 298093 0
none
Address [1] 298093 0
none
Country [1] 298093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299822 0
ahi evran üniversitesi tip fakültesi klinik arastirmalar etik kurulu
Ethics committee address [1] 299822 0
Ethics committee country [1] 299822 0
Turkey
Date submitted for ethics approval [1] 299822 0
15/12/2017
Approval date [1] 299822 0
26/12/2017
Ethics approval number [1] 299822 0
2017-20/242

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

Contacts
Principal investigator
Name 81674 0
Dr mehmet cantürk
Address 81674 0
ahi evran university training and research hospital address: kervansaray mahallesi 2019.sokak no:1 merkez/kirsehir/turkey p.k.40100
Country 81674 0
Turkey
Phone 81674 0
+905053574372
Fax 81674 0
Email 81674 0
[email protected]
Contact person for public queries
Name 81675 0
mehmet cantürk
Address 81675 0
ahi evran university training and research hospital address: kervansaray mahallesi 2019.sokak no:1 merkez/kirsehir/turkey p.k.40100
Country 81675 0
Turkey
Phone 81675 0
+905053574372
Fax 81675 0
Email 81675 0
[email protected]
Contact person for scientific queries
Name 81676 0
mehmet cantürk
Address 81676 0
ahi evran university training and research hospital address: kervansaray mahallesi 2019.sokak no:1 merkez/kirsehir/turkey p.k.40100
Country 81676 0
Turkey
Phone 81676 0
+905053574372
Fax 81676 0
Email 81676 0
[email protected]

No information has been provided regarding IPD availability


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
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