Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000585224
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
16/04/2018
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The depth of epidural space: Correlation of ultrasonographic measurements and the actual depth in patients undergoing inguinal hernia repair under combined spinal epidural anesthesia
Scientific title
Epidural Depth: The correlation of transverse plane and sagittal paramedian oblique plane distance measured with ultrasound and the actual depth in patients undergoing inguinal hernia repair under combined spinal epidural anesthesia
Secondary ID [1] 294088 0
none
Universal Trial Number (UTN)
U1111-1209-5734
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
combined spinal epidural anesthesia 306659 0
inguinal hernia repair 306660 0
Condition category
Condition code
Anaesthesiology 305759 305759 0 0
Other anaesthesiology
Musculoskeletal 305760 305760 0 0
Normal musculoskeletal and cartilage development and function

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 patient in accordance with the standards of American Society of Anesthesiologists. An anesthesiologist experienced in sonoanatomy will do the ultrasonographic examination of epidural space in both transverse and saggital 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 3ml 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] 300363 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304831 0
actual epidural depth will be determined . The actual epidural depth will be measured as follows: after locating epidural space with loss of resistance technique, epidural needle will be marked with a sterile permanent marker at skin level and after removal of epidural needle, the length of epidural needle will be measured with a tape measure from the marked point to the tip of the epidural needle.
Timepoint [1] 304831 0
following the acceptance of patient to operation room, just before the start of surgery
Primary outcome [2] 304834 0
epidural distance measured with ultrasonography at sagittal paramedian oblique plane will be determined.
Timepoint [2] 304834 0
following the acceptance of patient to operation room, just before the start of surgery
Primary outcome [3] 304835 0
epidural distance measured with ultrasonography at transverse plane will be measured
Timepoint [3] 304835 0
following the acceptance of patient to operation room, just before the start of surgery
Secondary outcome [1] 345491 0
none
Timepoint [1] 345491 0
none

Eligibility
Key inclusion criteria
patients scheduled for elective inguinal hernia repair with combined spinal epidural anesthesia aged between 18-80 years, with american society of anesthesiologists physical risk score<IV
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
American society of anesthesiologists physical risk score >3, any contraindication for spinal 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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2018
Actual
2/06/2018
Date of last participant enrolment
Anticipated
28/09/2018
Actual
25/09/2018
Date of last data collection
Anticipated
28/09/2018
Actual
25/09/2018
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 9604 0
Turkey
State/province [1] 9604 0
kirsehir

Funding & Sponsors
Funding source category [1] 298718 0
Hospital
Name [1] 298718 0
Ahi Evran University Training and Research Hospital
Country [1] 298718 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] 297892 0
None
Name [1] 297892 0
none
Address [1] 297892 0
none
Country [1] 297892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299665 0
ahi evran üniversitesi tip fakültesi klinik arastirmalar etik kurulu
Ethics committee address [1] 299665 0
Ethics committee country [1] 299665 0
Turkey
Date submitted for ethics approval [1] 299665 0
15/12/2017
Approval date [1] 299665 0
26/12/2017
Ethics approval number [1] 299665 0
2017-20/243

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

Contacts
Principal investigator
Name 81222 0
Dr mehmet cantürk
Address 81222 0
ahi evran university training and research hospital
address: kervansaray mahallesi 2019.sokak no:1
merkez/kirsehir/turkey
p.k.40100
Country 81222 0
Turkey
Phone 81222 0
+905053574372
Fax 81222 0
Email 81222 0
[email protected]
Contact person for public queries
Name 81223 0
mehmet cantürk
Address 81223 0
ahi evran university training and research hospital
address: kervansaray mahallesi 2019.sokak no:1
merkez/kirsehir/turkey
p.k.40100
Country 81223 0
Turkey
Phone 81223 0
+905053574372
Fax 81223 0
Email 81223 0
[email protected]
Contact person for scientific queries
Name 81224 0
mehmet cantürk
Address 81224 0
ahi evran university training and research hospital
address: kervansaray mahallesi 2019.sokak no:1
merkez/kirsehir/turkey
p.k.40100
Country 81224 0
Turkey
Phone 81224 0
+905053574372
Fax 81224 0
Email 81224 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
No additional documents have been identified.