Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000385448
Ethics application status
Approved
Date submitted
17/12/2015
Date registered
23/03/2016
Date last updated
23/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hip/Shoulder Size Ratio, Vertebral Column Length and the Spread of Spinal Anesthesia in Term Parturient
Scientific title
Hip/Shoulder Size Ratio and Vertebral Column Length and the Spread of Spinal Anesthesia in Term Parturient
Secondary ID [1] 288184 0
none
Universal Trial Number (UTN)
U1111-1177-8433
Trial acronym
HSRTTP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal anesthesia for cesarean section 297086 0
Condition category
Condition code
Reproductive Health and Childbirth 297325 297325 0 0
Childbirth and postnatal care
Anaesthesiology 297925 297925 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2ml 0.5% hyperbaric bupivacaine was injected intrathecally in 10 seconds without barbotage as a single dose from L4-L5 interspace of spinal cord by an anesthesiologist. The dose administered was controlled by the study staff as a standard dose of 2ml according to study protocol. Surgery started when the level of spinal anesthesia reached T6 dermatome
Intervention code [1] 293943 0
Treatment: Drugs
Intervention code [2] 293994 0
Treatment: Surgery
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296892 0
The effect of hip/shoulder size ratio on the spread of spinal anesthesia is detected by loss of pinprick discrimination at 5,10,20 and 30 minutes after administration of spinal anesthesia. The hip size was measured between the two iliac crests and the shoulder size between the two acromion processes of the patients by a tape measure at sitting position on a horizontal operating table. The hip/shoulder size ratio is the division of the two measures of the patient. The spinal anesthesia is assessed by pinprick discrimination starting from the anesthesized region upwards cranially at midaxillary line till the feeling changed from dullness to sharp pain.
Timepoint [1] 296892 0
primary outcome is assessed at 5,10,20 and 30 minutes after intrathecal injection of bupivacaine
Secondary outcome [1] 319636 0
The relation between the vertebral column length ( the measurements of vertebral column length was measured between the process of C7 vertebra to sacral hiatus and the distance from prominence of C7 vertebra to iliac crest by a tape measure) and the spread of spinal anesthesia (the spread of spinal anesthesia is assessed by pinprick discrimination starting from the anesthesized region upwords cranially at midaxillary line till the feeling changed from dullness to sharp pain) is assessed by correlation tests (Pearson and Spearman).
Timepoint [1] 319636 0
assessed at 5,10,20 and 30 minutes after intrathecal injection of bupivacaine
Secondary outcome [2] 321070 0
The correlation of spinal anesthesia spread (the spread of spinal anesthesia is assessed by pinprick discrimination starting from the anesthesized region upwords cranially at midaxillary line till the feeling changed from dullness to sharp pain.) and age of the patient was also assessed by Pearson and Spearman correlation tests
Timepoint [2] 321070 0
assessed at 5,10,20 and 30 minutes after intrathecal injection of bupivacaine
Secondary outcome [3] 321597 0
The correlation of spinal anesthesia spread (the spread of spinal anesthesia is assessed by pinprick discrimination starting from the anesthesized region upwords cranially at midaxillary line till the feeling changed from dullness to sharp pain.) and height of the patient was also assessed by Pearson and Spearman correlation tests
Timepoint [3] 321597 0
assessed at 5,10,20 and 30 minutes after intrathecal injection of bupivacaine
Secondary outcome [4] 321598 0
The correlation of spinal anesthesia spread (the spread of spinal anesthesia is assessed by pinprick discrimination starting from the anesthesized region upwords cranially at midaxillary line till the feeling changed from dullness to sharp pain.) and weight of the patient was also assessed by Pearson and Spearman correlation tests
Timepoint [4] 321598 0
5,10,20 and 60 minutes after administration of spinal anesthesia
Secondary outcome [5] 321599 0
The correlation of spinal anesthesia spread (the spread of spinal anesthesia is assessed by pinprick discrimination starting from the anesthesized region upwords cranially at midaxillary line till the feeling changed from dullness to sharp pain.) and BMI of the patient was also assessed by Pearson and Spearman correlation tests
Timepoint [5] 321599 0
5,10,20 and 60 minutes after administration of spinal anesthesia

Eligibility
Key inclusion criteria
patients consenting to spinal anesthesia for cesarean section
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
patients rejecting spinal anesthesia or any contraindication for spinal anesthesia

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
sample size was determined by G*power statistical analysis program based on preliminary results of the study. A sample size 0f 72 was calculated to provide a %90 confidence interval. Kolmogorov – Smirnow and Shapiro – Wilk tests, repeated measures ANOVA, Friedman test, Tukey HSD, Sperman’s Rho Correlation Test, multiple regression analysis test But we determined the sample size to be 75 to overcome the possible dropdown patients

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/10/2015
Date of last participant enrolment
Anticipated
Actual
10/12/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 7471 0
Turkey
State/province [1] 7471 0
kirsehir

Funding & Sponsors
Funding source category [1] 292580 0
Self funded/Unfunded
Name [1] 292580 0
mehmet canturk
Country [1] 292580 0
Primary sponsor type
Individual
Name
Mehmet Canturk
Address
Medical doctor at government hospital
asikpasa mahallesi
sehit ahmet dogangun caddesi
caglar apartmani
30/8
merkez/kirsehir/Turkey p.k. +904100
p.k. +9040100
Country
Turkey
Secondary sponsor category [1] 291714 0
None
Name [1] 291714 0
Address [1] 291714 0
Country [1] 291714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294061 0
Turgut Ozal University Clinical Trials Ethics Committee
Ethics committee address [1] 294061 0
Ethics committee country [1] 294061 0
Date submitted for ethics approval [1] 294061 0
27/08/2015
Approval date [1] 294061 0
08/10/2015
Ethics approval number [1] 294061 0
99950669/217

Summary
Brief summary
There are more than twenty factors in the literature defined to effect the spinal anesthesia spread. In patients with a larger hip size and a narrow shoulder size, more cephalad spread of spinal anesthesia induced with a fixed amount of hyperbaric bupivacaine is observed. We hypothesized that the increase in cephalad spread is strongly correlated with the increased hip/shoulder size ratio.
Age, weight, height, body mass index, hip size, shoulder size, hip/shoulder size ratio, vertebral column length were recorded for 75 term parturient. The L4-L5 interspace was entered and 2ml 0.5% hyperbaric bupivacaine was given intrathecal in 10 seconds without barbotage. Pearson Correlation Test was performed for the correlation between age, height, weight, body mass index, hip/shoulder size ratio, and vertebral column length
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62274 0
Dr Mehmet Canturk
Address 62274 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3.Kat Ameliyathane
Kervansaray Mahallesi
2019. sokak
no:1
p.k. +9040100
kirsehir
Country 62274 0
Turkey
Phone 62274 0
+905053574372
Fax 62274 0
Email 62274 0
drmcanturk@gmail.com
Contact person for public queries
Name 62275 0
Dr Mehmet Canturk
Address 62275 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3.Kat Ameliyathane
Kervansaray Mahallesi
2019. sokak
no:1
p.k. +9040100
kirsehir
Country 62275 0
Turkey
Phone 62275 0
+905053574372
Fax 62275 0
Email 62275 0
drmcanturk@gmail.com
Contact person for scientific queries
Name 62276 0
Dr Mehmet Canturk
Address 62276 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3.Kat Ameliyathane
Kervansaray Mahallesi
2019. sokak
no:1
p.k. +9040100
kirsehir
Country 62276 0
Turkey
Phone 62276 0
+905053574372
Fax 62276 0
Email 62276 0
drmcanturk@gmail.com

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