Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000479404
Ethics application status
Approved
Date submitted
17/02/2016
Date registered
12/04/2016
Date last updated
12/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of anthropometric characteristics on the spread of hyperbaric bupivacaine spinal anaesthesia in patients undergoing lower abdominal or lower extremity surgery.
Scientific title
The effect of anthropometric characteristics on the spread of spinal anesthesia with 0.5% hyperbaric bupivacaine in patients undergoing lower abdominal or lower extremity surgery
Secondary ID [1] 288346 0
None
Universal Trial Number (UTN)
U1111-1178-6708
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unilateral Inguinal Hernia 297341 0
Unilateral Arthropathy 297342 0
surgery under spinal anesthesia 297344 0
Condition category
Condition code
Musculoskeletal 297538 297538 0 0
Other muscular and skeletal disorders
Anaesthesiology 298110 298110 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 ml 0.5% hyperebaric bupivacaine was injected intrathecally in 15 seconds wiithout barbotage as a single dose from L4-L5 interspace of spinal canal by an anesthesiologist. The dose administered was controlled by the study staff as a standard dose of 3ml according to study protocol. Surgery started when the level of spinal anesthesia reached to T10 dermatome
Intervention code [1] 293944 0
Treatment: Drugs
Intervention code [2] 294150 0
Treatment: Other
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297093 0
To detect the effect of HSR (hip width divided to shoulder width) on the spread of spinal anesthesia with 0.5% hyperbaric bupivacaine at lateral position. The hip width is measured between two iliac crests and th shoulder width between the two acromion processes of the patients by a tape measure at sitting position on a horizontal operating table. the spread o spinal anesthesia is assessed by pinprick discrimination starting from the anesthetized region upwards cranially at midaxillary line till the feeling changed from dullness to sharp pain.
Timepoint [1] 297093 0
5,10,20 and 30 minutes after intrathecal injection of 0.5% hyperbaric bupivacaine
Secondary outcome [1] 320012 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) an the spead of spinal anesthesia ( the spread of spinal anesthesia is assessed by pinprick discrimination starting from the anesthetized region upwards cranially at midaxillary line till the feeling changed from dullness to sharp pain) is assessed by correlation tests ( Pearson and Spearman).
Timepoint [1] 320012 0
5,10,20,and 30 minutes after intrathecal administration of 0.5% hyperbaric bupivacaine
Secondary outcome [2] 321601 0
The correlation of spinal anesthesia spread ( the spread of spinal anesthesia is assessed by pinprick discrimination starting from the anesthetized region upwards 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] 321601 0
5,10,20,and 30 minutes after intrathecal administration of 0.5% hyperbaric bupivacaine
Secondary outcome [3] 321602 0
The correlation of spinal anesthesia spread ( the spread of spinal anesthesia is assessed by pinprick discrimination starting from the anesthetized region upwards 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 [3] 321602 0
5,10,20,and 30 minutes after intrathecal administration of 0.5% hyperbaric bupivacaine
Secondary outcome [4] 321603 0
The correlation of spinal anesthesia spread ( the spread of spinal anesthesia is assessed by pinprick discrimination starting from the anesthetized region upwards 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 [4] 321603 0
5,10,20,and 30 minutes after intrathecal administration of 0.5% hyperbaric bupivacaine
Secondary outcome [5] 321604 0
The correlation of spinal anesthesia spread ( the spread of spinal anesthesia is assessed by pinprick discrimination starting from the anesthetized region upwards cranially at midaxillary line till the feeling changed from dullness to sharp pain) and body mass index (BMI) of the patient was also assessed by Pearson and Spearman correlation tests
Timepoint [5] 321604 0
5,10,20,and 30 minutes after intrathecal administration of 0.5% hyperbaric bupivacaine

Eligibility
Key inclusion criteria
patients approving spinal anesthesia and the study protocol for the surgery that he/she is undergoing( either lower extremity or lower abdominal surgery).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients refusing spinal anesthesia or the study protocol, any contraindication for spinal anesthesia, age greater than 75 years or smaller than 18 years

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
Patient size is determined by G*power statistical analysis program based on the preliminary results of the study. A sample size of 53 was calculate to provide a %80 confidence interval. Kolmogorov-Smirnow and Shapiro-Wilk tests, repeated measures ANOVA , Freidman test, Tukey HSD, Spearman's Rho Correlation test were used for the analysis of the data. we determined the sample size 60 to overcome the possible dropdown patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/10/2015
Date of last participant enrolment
Anticipated
Actual
30/12/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7596 0
Turkey
State/province [1] 7596 0
kirsehir

Funding & Sponsors
Funding source category [1] 292905 0
Self funded/Unfunded
Name [1] 292905 0
mehmet canturk
Country [1] 292905 0
Turkey
Primary sponsor type
Individual
Name
Mehmet Canturk
Address
ahi evran university education and research hospital
address: kervansaray mahallesi 2019. sokak no : 1
merkez/kirsehir/Turkey
p.k. 40100
Country
Turkey
Secondary sponsor category [1] 291652 0
None
Name [1] 291652 0
none
Address [1] 291652 0
none
Country [1] 291652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294405 0
Turgut Ozal University Clinical Trials Ethical Comittee
Ethics committee address [1] 294405 0
Ayvali Mahallesi
Gazze Caddesi
No:7
Ankara
Turkey
p.k. 06400
Ethics committee country [1] 294405 0
Turkey
Date submitted for ethics approval [1] 294405 0
27/08/2015
Approval date [1] 294405 0
08/10/2015
Ethics approval number [1] 294405 0
99950669/216

Summary
Brief summary
Background:Several factors have been described to effect the spread of spinal anesthesia. Clinical sense says that patients with a larger hip size and a narrow shoulder size have a relative trendelenburg position on a horizontal operation table that results in more cephalad spread of the hyperbaric local anesthetic solution although there is no clinical study reporting the effect of hip/shoulder size ratio on the spread of spinal anesthesia.We hypothesized that the increase in cephalad spread is strongly correlated with the increased hip/shoulder size ratio.
Methods: Age, weight, height, body mass index, hip size, shoulder size, hip/shoulder size ratio, vertebral column length were recorded for 75 patients. The L4-L5 interspace was introduced at lateral position on a horizontal operation table with a 25G spinal needle and 3ml 0.5% hyperbaric bupivacaine was injected intrathecal in 15 seconds without barbotage and patient was turned supine 5 minutes after intrathecal injection. Pearson and Sperman’sRho Correlation Tests were performed for the relation between age, height, weight, body mass index, hip size, hip/shoulder size ratio, shoulder size and vertebral column length and the multiple regression analysis was used to test the combined contribution of the above variables on cephalad spread of spinal anesthesia.
Results:We determined a positive correlation with hip/shoulder size ratio (r = 0, 40; p = 0,002), and a negative correlation with the height (r= -0, 29; p=0,026), and the shoulder size (r= -0, 31; p= 0,017) of the patients with the cephalad spread ofspinal anesthesia. Multiple regression analysis showed that hip size and the hip/shoulder size ratio were the important determinants for the cephalad spread of spinal anesthesia and the other variables had no effect.
Conclusions: The cephalad spread of spinal anesthesia with a fixed dose of hyperbaric bupivacaine is affected by the ratio of hip/shoulder size, shoulder size and the height of the patient. Vertebral column length has no effect on spinal anesthesia spread.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62842 0
Dr mehmet canturk
Address 62842 0
ahi evran university education and research hospital
address: kervansaray mahallesi 2019. sokak no : 1
merkez/kirsehir/Turkey
p.k. 40100
Country 62842 0
Turkey
Phone 62842 0
+905053574372
Fax 62842 0
Email 62842 0
[email protected]
Contact person for public queries
Name 62843 0
Dr mehmet canturk
Address 62843 0
ahi evran university education and research hospital
address: kervansaray mahallesi 2019. sokak no : 1
merkez/kirsehir/Turkey
p.k. 40100
Country 62843 0
Turkey
Phone 62843 0
+905053574372
Fax 62843 0
Email 62843 0
[email protected]
Contact person for scientific queries
Name 62844 0
Dr mehmet canturk
Address 62844 0
ahi evran university education and research hospital
address: kervansaray mahallesi 2019. sokak no : 1
merkez/kirsehir/Turkey
p.k. 40100
Country 62844 0
Turkey
Phone 62844 0
+905053574372
Fax 62844 0
Email 62844 0
[email protected]

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