Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000586213
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
17/04/2018
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The correlation of abdominal girth with epidural depth measured with ultrasound in patients scheduled for inguinal hernia repair surgery under combined spinal epidural anesthesia
Scientific title
The correlation of abdominal girth with epidural depth measured with ultrasound in patients scheduled for inguinal hernia repair surgery under combined spinal epidural anesthesia
Secondary ID [1] 294089 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inguinal hernia surgery 306664 0
spinal anesthesia 306665 0
Condition category
Condition code
Anaesthesiology 305763 305763 0 0
Other anaesthesiology
Musculoskeletal 305764 305764 0 0
Normal musculoskeletal and cartilage development and function
Surgery 305765 305765 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
after patient is accepted to the operation room and monitorized according to american society of anesthesiologists standards, age, height, weight, vertebral column length and abdominal girth of the patients will be recorded. vertebral column length will be measured using a tape meter starting from the spinous process of 7th cervical vertebra to sacral hiatus. abdominal girth will be measured using a tape meter at the level of umblicus. an anesthesiologist experienced in sonoanatomy will examin the lumbar epidural depth of the patient with convex probe at transverse plane and sagittal paramedian oblique plane just before the start of surgery in a few minutes. the measurements will be recorded for each patient.
Intervention code [1] 300365 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304839 0
primary outcome of the study is to determine abdominal girth as measured with a tape measure at the level of umblicus.
Timepoint [1] 304839 0
following the acceptance of patient to operation room, just before the start of surgery
Primary outcome [2] 305429 0
primary outcome of the study is to determine epidural depth measured with ultrasound at sagittal paramedian oblique plane
Timepoint [2] 305429 0
following the acceptance of patient to operation room, just before the start of surgery
Primary outcome [3] 305499 0
primary outcome of the study is to determine epidural depth measured with ultrasound at transverse plane
Timepoint [3] 305499 0
following the acceptance of patient to operation room, just before the start of surgery
Secondary outcome [1] 343333 0
One of the secondary outcome of the study is to determine vertebral column length as measured using a tape meter starting from the spinous process of 7th cervical vertebra to sacral hiatus
Timepoint [1] 343333 0
Measurements will be done following the acceptance of patient to operation room, just before the start of surgery.
Secondary outcome [2] 343334 0
One of the composite secondary outcomes of the study is to determine patient's height determined using a tape measure in centimeters while patient is lying on the operation table starting from hills to top level of patients' head or the self reported height which was measured at preoperative visit at anesthesiology policlinics and the measured height information was told to the patient will be used.
Timepoint [2] 343334 0
Measurements will be done following the acceptance of patient to operation room, just before the start of surgery.
Secondary outcome [3] 343335 0
One of the composite secondary outcomes of the study is to determine patients' body mass index (BMI, weight in kilograms divided by height in meters) from self reported information of weight and height of the patients.
Timepoint [3] 343335 0
Measurements will be done following the acceptance of patient to operation room, just before the start of surgery.

Eligibility
Key inclusion criteria
patients scheduled for inguinal hernia repair surgery under combined spinal epidural anesthesia with amercan society of anesthesiologist physical status I-III
Minimum age
18 Years
Maximum age
81 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patient refusal to participate into the study, american society of anesthesiologists physical status>III, any contraindication for regional anesthesia, bleeding disorders or history of anticoagulant drug use, spinal or spinal canal surgery history, pregnant patients.

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 mesaurements of epidural depth at transverse plane and saggital paramedian oblique plane and patients' abdominal girth, vertebral column length,age, and body mass index.

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
28/08/2018
Date of last data collection
Anticipated
31/08/2018
Actual
28/08/2018
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 9606 0
Turkey
State/province [1] 9606 0
kirsehir

Funding & Sponsors
Funding source category [1] 298721 0
Hospital
Name [1] 298721 0
Ahi Evran University Training and Research Hospital
Country [1] 298721 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] 298412 0
None
Name [1] 298412 0
Address [1] 298412 0
Country [1] 298412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299666 0
ahi evran üniversitesi tip fakültesi klinik arastirmalar etik kurulu
Ethics committee address [1] 299666 0
ahi evran üniversitesi tip fakültesi bagbasi yerleskesi Kat : 0, 40100, merkez, kirsehir, Turkey
Ethics committee country [1] 299666 0
Turkey
Date submitted for ethics approval [1] 299666 0
15/12/2017
Approval date [1] 299666 0
26/12/2017
Ethics approval number [1] 299666 0
2017-20/241

Summary
Brief summary
Combined spinal epidural anesthesia is commonly used for inguinal hernia repair in our institution. to increase patient safety and success rate of combined spinal epidural anesthesia and also decrease the incidence of probable complications related to regional anesthesia technique, the use of ultrasound guidence is increasing among anesthesiologists. ultrasound enables the accurate localisation of the intervertebral space for puncture site and also helps the practiotioner safely introduce the epidural needle to a certain depth. the correlation of epidural depth measured with ultrasound and some patient variables were studied in the literature but the current study is unique in studying the correlation between abdominal girth and epidural depth measured with ultrasound at saggital paramedian oblique plane and transverse plane.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81226 0
Dr mehmet cantürk
Address 81226 0
ahi evran university training and research hospital
kervansaray mahallesi 2019.sokak no:1
merkez/kirsehir/turkey
p.k.40100
Country 81226 0
Turkey
Phone 81226 0
+905053574372
Fax 81226 0
Email 81226 0
[email protected]
Contact person for public queries
Name 81227 0
Dr mehmet cantürk
Address 81227 0
ahi evran university training and research hospital
kervansaray mahallesi 2019.sokak no:1
merkez/kirsehir/turkey
p.k.40100
Country 81227 0
Turkey
Phone 81227 0
+905053574372
Fax 81227 0
Email 81227 0
[email protected]
Contact person for scientific queries
Name 81228 0
Dr mehmet cantürk
Address 81228 0
ahi evran university training and research hospital
kervansaray mahallesi 2019.sokak no:1
merkez/kirsehir/turkey
p.k.40100
Country 81228 0
Turkey
Phone 81228 0
+905053574372
Fax 81228 0
Email 81228 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
SourceTitleYear of PublicationDOI
EmbaseAbdominal girth has a strong correlation with actual and ultrasound estimated epidural depth.2019https://dx.doi.org/10.3906/sag-1902-115
N.B. These documents automatically identified may not have been verified by the study sponsor.