Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000538549
Ethics application status
Approved
Date submitted
9/04/2015
Date registered
27/05/2015
Date last updated
27/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of lumbar anaesthesia on sympathetic activity below the level of the block
Scientific title
Area under curve of the photoplethysmographic signal as the evaluation measure for sympathetic activity during lumbar epidural anaesthesia
Secondary ID [1] 286494 0
None
Universal Trial Number (UTN)
U1111-1169-1192
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sympathetic activity during lumbar epidural anaesthesia 294704 0
Condition category
Condition code
Anaesthesiology 294996 294996 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Only one group of patients was included in the study. 0.5% bupivacaine was injected in the L3/L4 level by the qualified anaesthesiologist and Biopac SS4LA Pulse Plethysmograph. Photoplethysmography recordings were taken before lumbar epidural anaesthesia procedure was done, as well as during the whole surgical procedure and during the post-anaesthesia recovery (until all of the sensoric functions of the lower limbs were recovered). Transducer was used for photoplethysmography recording. Amplitude (maximum PPG sygnal), pulse transit time and area under the curve were recorded.
Intervention code [1] 291589 0
Early detection / Screening
Comparator / control treatment
Only one group of patients was included in the study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294745 0
Correlation of epidural anaesthesia success (meaning clinically successful: the degree of reducement of the pain caused by the surgical procedure ; no tools were used for assesing the pain because the patients were subjected to painful surgical stimulus ; that means that in all of the patients which were included in the study, the pain was reduced to the level of feeling no pain at all during surgical stimulation) with the area under the curve of the photoplethysmographic signal which is measured by the Biopac SS4LA Pulse Plethysmograph Transducer.
Timepoint [1] 294745 0
Few minutes after lumbar epidural anaesthesia application.
Secondary outcome [1] 313987 0
No secondary outcomes
Timepoint [1] 313987 0
No secondary outcomes

Eligibility
Key inclusion criteria
40 patients aged 18-45 which underwent surgical procedure under epidural anaesthesia.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pulses of the arteria tibialis posterior and arteria dorsalis pedis are not palpable
perspiration of the feet is not maintained
abnormal growth and transparency of the nails
changes which indicate pathological alteration of the blood vessels of the lower extremities

Study design
Purpose of the study
Diagnosis
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 2
Type of endpoint/s
Statistical methods / analysis
Differences between two measurements of the single parameters of the same examinees will be tested by the nonparametric test for dependent samples (Wilcoxon Matched-Pairs Test). Differences between three or more measurements of the single parameters of the same examinees will be tested by the nonparametric analysis of the variance for dependent samples (Friedman ANOVA). As the statistically significant limit, p<0,005 was chosen. Statistical analysis will be done on PC computer, in program Statistica 6. Number of 40 patients was chosen as objective number for the study due to clinical experience in giving successful epidural anaesthesia.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/05/2015
Actual
4/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 6792 0
Croatia
State/province [1] 6792 0
City of Zagreb, Clinical Hospital Center Zagreb

Funding & Sponsors
Funding source category [1] 291057 0
Hospital
Name [1] 291057 0
Department for Anaesthesiology and Intensive Care Medicine, Clinic for Surgery, Clinical Hospital Center Zagreb, Zagreb, Croatia
Country [1] 291057 0
Croatia
Primary sponsor type
Hospital
Name
Clinical Hospital Center Zagreb
Address
Kispaticeva 12, 10000 Zagreb, Croatia
Country
Croatia
Secondary sponsor category [1] 289740 0
None
Name [1] 289740 0
Address [1] 289740 0
Country [1] 289740 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Photoplethysmographic signal reflects sympathetic activity under the level of epidural block. The height of sensory block during epidural anaesthesia reflects the height of sympathetic block. Area under the photoplethysmographic curve (AUC) depends on variability of the photoplethysmographic signal strenght and duration. Our hypothesis is that change in any parameter, due to the sympathetic block, will change the area under the curve of the photoplethysmographic signal.
40 patients with epidural anaesthesia will be included in the research. 0.5% bupivacaine will be injected in the L3/L4 level and Biopac SS4LA Pulse Plethysmograph Transducer will be used for photoplethysmography recording. Amplitude (maximum PPG sygnal), pulse transit time and area under the curve will be recorded. Our goal is to test sympathetic activity using variabilities, shapes and characteristics of the PPG curve (area under the curve) during 0.5% bupivacaine epidural anaesthesia.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56378 0
Dr Slobodan Mihaljevic
Address 56378 0
Clinical Hospital Center Zagreb, Obstetrics and Gynecology Clinic
Petrova 13
10000 Zagreb, Croatia
Country 56378 0
Croatia
Phone 56378 0
+385915024223
Fax 56378 0
Email 56378 0
smsmihaljevic@gmail.com
Contact person for public queries
Name 56379 0
Kresimir Reiner
Address 56379 0
Clinical Hospital Center Zagreb, Obstetrics and Gynecology Clinic
Petrova 13
10000 Zagreb, Croatia
Country 56379 0
Croatia
Phone 56379 0
+385917615364
Fax 56379 0
Email 56379 0
kresimirovichmd@gmail.com
Contact person for scientific queries
Name 56380 0
Kresimir Reiner
Address 56380 0
Clinical Hospital Center Zagreb, Obstetrics and Gynecology Clinic
Petrova 13
10000 Zagreb, Croatia
Country 56380 0
Croatia
Phone 56380 0
+385917615364
Fax 56380 0
Email 56380 0
kresimirovichmd@gmail.com

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.