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Trial registered on ANZCTR


Registration number
ACTRN12616001541493
Ethics application status
Approved
Date submitted
2/10/2016
Date registered
8/11/2016
Date last updated
22/11/2018
Date data sharing statement initially provided
22/11/2018
Date results information initially provided
22/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of plasma levobupivacaine concentrations following thoracic epidural analgesia (TEA) and subpleural analgesia (SPA).
Scientific title
A comparison of plasma levobupivacaine concentrations following thoracic epidural analgesia and intrapleural analgesia - a comparison of pharmacokinetics of levobupivacaine, analgesic effectiveness and complication rate in pacient undergoing thoracotomy.
Secondary ID [1] 290255 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
open thoracic surgery 300469 0
epidural analgesics 300470 0
Subpleural analgesia 300471 0
levobupivacaine pharmacokinetics 300472 0
Condition category
Condition code
Anaesthesiology 300325 300325 0 0
Pain management
Surgery 300326 300326 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Thoracotomy - diagnostic or therapeutic.anterolateral thoracotomy.

2. Introduction of either thoracic epidural analgesia (TEA) or subpleural (SPA) - epidural or subpleural cathether insertion.
TEA group.
Insertion of epidural catheter prior surgery using midline or paramedian approach ( level Th2-Th7 depending on surgical procedure). Surgery under general anaesthesia. Immediatelly after thoracotomy closure, bolus of 0,25% 0,25ml/kg levobupivacaine (Chirocaine, AbbVie Ltd., Wanwall, UK) will be given into the epi-catheter.
SPA group.
Surgery under general anaesthesia (the same type as in TEA group). Insertion of Subpleural cathether placement subpleuraly into paravertebral space before thoracotomy closure under direct visual control of a surgeon. Immediatelly after thoracotomy closure, bolus of 0,25% 0,25ml/kg levobupivacaine (Chirocaine, AbbVie Ltd., Wanwall, UK) will be given into the subpleural catheter.
Intervention code [1] 296046 0
Treatment: Drugs
Comparator / control treatment
Comparison between TEA and IPA group.
Control group
Active

Outcomes
Primary outcome [1] 299789 0
Measuring of levobupivacaine plasma concentration in 30, 60 and 120 minutes after levobupivacaine bolus (dose/kg) application. Mean maximum plasma concentration (Cmax) and mean time to reach Cmax (Tmax) will be reported.
Timepoint [1] 299789 0
Levobupivacaine plasma levels in 30,60 and 120 minutes after application.
Secondary outcome [1] 328119 0
Visual analogue scale (VAS) evaluation of postoperative pain.
Timepoint [1] 328119 0
Evaluation of VAS in 1, 2, 6, 12 and 24 hours.
Secondary outcome [2] 328121 0
Mobility score (AMPAC) evaluation.
Timepoint [2] 328121 0
AMPAC evaluation in 1, 2, 6, 12 and 24 hours after the surgery.
Secondary outcome [3] 328624 0
Necessity of pharmacological support of circulation (noradrenalin administration and dosing to maintain mean arterial pressure between 70-85mmHg).
Assessed by review of the medical charts.
Timepoint [3] 328624 0
Evaluation in 1, 2, 6, 12 and 24 hours after the surgery.
Secondary outcome [4] 328984 0
Complications related to local anaesthetic toxicity:
O - none
C - cardiac - new heart rhythm pathologies
N - neurological - signs of local anaesthetic toxicity - blurred vision, metal taste, seizures, coma
Assessed by review of the medical charts.
Timepoint [4] 328984 0
Evaluation in 1, 2, 6, 12 and 24 hours after the surgery.

Eligibility
Key inclusion criteria
1. elective surgery (thoracotomy)
2. ASA status I-IV
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age < 18 years
2. Acute or emergent surgery
3. Contraindication of both TEA and IPA method
4. Refusal of both TEA and IPA by a patient.
5. Chronic pain prior to surgery.
6. Known allergy to painkillers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes. Study had been randomised prior to any enrolments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Randomisation was performed prior to enrolments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
A prospective study.
3 venous blood samples will be obtained at 30, 60 and 120 minutes after injection of studied drug (levobupivacaine).
44 patients will be included (22 TEA, 22 SPA) with an effect size of 0,05 and a statistical power of 0,8.
To determine the maximum plasma concentration (Cmax) and time-to-reach Cmax (Tmax) in each group, a non-linear regression analysis will be performed using a two-compartment model of measured plasma concentrations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8287 0
Czech Republic
State/province [1] 8287 0
Czech Rep/Prague

Funding & Sponsors
Funding source category [1] 294620 0
Hospital
Name [1] 294620 0
General University Hospital in Prague
Address [1] 294620 0
U Nemocnice 2, Prague 2, 12800
Country [1] 294620 0
Czech Republic
Primary sponsor type
Hospital
Name
General University Hospital in Prague
Address
U Nemocnice 2
Prague 2
12800
Country
Czech Republic
Secondary sponsor category [1] 293482 0
None
Name [1] 293482 0
Address [1] 293482 0
Country [1] 293482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296061 0
Ethics committee of General University Hospital, Prague
Ethics committee address [1] 296061 0
Na Bojisti 1
Prague 2
128 00
Ethics committee country [1] 296061 0
Czech Republic
Date submitted for ethics approval [1] 296061 0
05/09/2016
Approval date [1] 296061 0
15/12/2016
Ethics approval number [1] 296061 0
1635/16 S-IV

Summary
Brief summary
A comparison ot two groups with either TEA or IPA after thoracotomy. The aim of the prospective study is to compare a blood concentrations of levobupivacaine 30, 60 and 120 minutes after an injection. Futher, possible side effects of levobupivacaine as well as analgesic effectivness (VAS, AM-PAC score) will be monitored and related to measured blood levobupivacaine concentrations.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2946 2946 0 0
Attachments [2] 2947 2947 0 0
Attachments [3] 2948 2948 0 0
Attachments [4] 2949 2949 0 0

Contacts
Principal investigator
Name 69414 0
Dr Jan Matek
Address 69414 0
1st Surgical Department
General University Hospital
U nemocnice 2
Prague 2
128 00
Country 69414 0
Czech Republic
Phone 69414 0
+420224962215
Fax 69414 0
Email 69414 0
jan.matek@vfn.cz
Contact person for public queries
Name 69415 0
A/Prof Pavel Michalek
Address 69415 0
Dept of Anesthesia and Intensive Care Medicine
General University Hospital
U nemocnice 2
Prague 2
128 00
Country 69415 0
Czech Republic
Phone 69415 0
+420224962118
Fax 69415 0
Email 69415 0
pavel.michalek@vfn.cz
Contact person for scientific queries
Name 69416 0
A/Prof Pavel Michalek
Address 69416 0
Dept of Anesthesia and Intensive Care Medicine
General University Hospital
U nemocnice 2
Prague 2
128 00
Country 69416 0
Czech Republic
Phone 69416 0
+420224962118
Fax 69416 0
Email 69416 0
pavel.michalek@vfn.cz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Clinical study report
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary