Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000584235
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 correlation of abdominal girth and the epidural depth measured with ultrasound in parturients
Scientific title
The correlation of abdominal girth and the epidural depth measured with ultrasound in parturients scheduled for elective cesarean section under combined spinal epidural anesthesia
Secondary ID [1] 294090 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 306667 0
Condition category
Condition code
Anaesthesiology 305766 305766 0 0
Other anaesthesiology
Musculoskeletal 305767 305767 0 0
Normal musculoskeletal and cartilage development and function
Reproductive Health and Childbirth 305768 305768 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
after acceptance of patient to the operation room and standard monitorisation, age, height, weight, vertebral column length, abdominal girth measurements will be recorded. abdominal girth will be mesaured using a tape meter at the level of umblicus. vertebral column length will be measured from the spinous process of 7th cervical vertebra to sacral hiatus. epidural depth will be measured by an anesthesiologist experienced in sonoanatomy at sagittal paramedian oblique plane and transverse plane in 15 minutes. the measured epidural depths will be recorded
Intervention code [1] 300366 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304840 0
Abdominal girth as measured with a tape measure at the level of umblicus in horizontal plane
Timepoint [1] 304840 0
following the acceptance of patient to operation room, just before the start of surgery
Primary outcome [2] 305428 0
Epidural depth measured with ultrasound at transverse plane.
Timepoint [2] 305428 0
following the acceptance of patient to operation room, just before the start of surgery
Primary outcome [3] 305500 0
Epidural depth as measured with ultrasound at sagittal paramedian oblique plane.
Timepoint [3] 305500 0
following the acceptance of patient to operation room, just before the start of surgery
Secondary outcome [1] 343337 0
secondary outcome of the study is to determine the parturients' body mass index calculated by dividing the weight of the patient (self reported) divided by the square of height in meters (measured with a tape meter).
Timepoint [1] 343337 0
following the acceptance of patient to operation room, just before the start of surgery.
Secondary outcome [2] 343338 0
Vertebral column length as measured using a tape meter starting from the spinous process of 7th cervical vertebra to sacral hiatus.
Timepoint [2] 343338 0
following the acceptance of patient to operation room, just before the start of surgery.

Eligibility
Key inclusion criteria
parturients scheduled for elective cesarean section under combined spinal epidural anesthesia with american society of anesthesiologists physical status I-II
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
complicated pregnancies, multiple pregnancies, presentation abnormalities, patient refusal to be involved in the study, patient refusal for regional anesthesia, any contraindication for regional anesthesia, emergency cases, american society of anesthesiologists physical status >II, history of anticoagulant drug use, history of spine or spinal canal surgery

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 epidural depth measured with ultrasound at saggital paramedian oblique plane and transverse plane and parturients' abdominal girth, age, body mass index, and vertebral column length.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2018
Actual
1/06/2018
Date of last participant enrolment
Anticipated
31/08/2018
Actual
30/08/2018
Date of last data collection
Anticipated
31/08/2018
Actual
30/08/2018
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 9607 0
Turkey
State/province [1] 9607 0
kirsehir

Funding & Sponsors
Funding source category [1] 298722 0
Hospital
Name [1] 298722 0
Ahi Evran University Training and Research Hospital
Country [1] 298722 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] 297894 0
None
Name [1] 297894 0
Address [1] 297894 0
Country [1] 297894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299667 0
ahi evran üniversitesi tip fakültesi klinik arastirmalar etik kurulu
Ethics committee address [1] 299667 0
ahi evran üniversitesi tip fakültesi bagbasi yerleskesi Kat: 0, 40100, merkez, kirsehir, Turkey
Ethics committee country [1] 299667 0
Turkey
Date submitted for ethics approval [1] 299667 0
15/12/2017
Approval date [1] 299667 0
26/12/2017
Ethics approval number [1] 299667 0
2017-20/240

Summary
Brief summary
combined spinal epidural anesthesia is commonly performed for cesarean section surgery at our institution. anatomical landmarks are often hard to localize in pregnant patient population. ultrasound navigation for combined spinal epidural anesthesia provides fast, easy and reliable intervertebral interspace localization together with decreasing the risk of introducing epidural needle from higher dermatomes above second lumbar vertebra which is a common risk when performed with conventional palpation technique. ultrasonographic examination of lumbar vertebra also provides knowledge about the depth of epidural space which preserves the clinican the knowledge that how deep he/she can introduce the needle within safety margins. several patient variables were investigated to affect the epidural depth mesured with ultrasound. up to our knowledge the current study is unique in studying the correlation between parturients' abdominal girth and the epidural depth measured at saggital paramedian oblique plane and transverse plane with ultrasound.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81230 0
Dr mehmet cantürk
Address 81230 0
ahi evran university training and research hospital
address: kervansaray mahallesi 2019. sokak no:1
merkez/kirsehir/turkey
p.k. 40100
Country 81230 0
Turkey
Phone 81230 0
+905053574372
Fax 81230 0
Email 81230 0
[email protected]
Contact person for public queries
Name 81231 0
Dr mehmet cantürk
Address 81231 0
ahi evran university training and research hospital
address: kervansaray mahallesi 2019. sokak no:1
merkez/kirsehir/turkey
p.k. 40100
Country 81231 0
Turkey
Phone 81231 0
+905053574372
Fax 81231 0
Email 81231 0
[email protected]
Contact person for scientific queries
Name 81232 0
Dr mehmet cantürk
Address 81232 0
ahi evran university training and research hospital
address: kervansaray mahallesi 2019. sokak no:1
merkez/kirsehir/turkey
p.k. 40100
Country 81232 0
Turkey
Phone 81232 0
+905053574372
Fax 81232 0
Email 81232 0
[email protected]

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