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
ACTRN12618001495213p
Ethics application status
Submitted, not yet approved
Date submitted
5/06/2018
Date registered
5/09/2018
Date last updated
5/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain relief and safety of the Erector Spinae Block in patients undergoing chest surgery
Scientific title
Efficacy and Safety of the Erector Spinae Block in the management of patients undergoing video-assisted thorascopic surgery (VATS)
Secondary ID [1] 295093 0
Nil known
Universal Trial Number (UTN)
U1111-1215-1992
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erector Spinae Block 308154 0
Thoracic Surgery Analgesia 308155 0
Condition category
Condition code
Anaesthesiology 307196 307196 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Performing an erector spinae block in patients undergoing video-assisted thorascopic surgery at the Royal Brisbane and Women's Hospital and The Prince Charles Hospital:

After informed consent, placement of the ESB will proceed in the sitting position in a similar fashion to a paravertebral or neuraxial block by the treating anaesthetist with appropriate training or specialist regional anaesthesia anaesthetist. The posterior hemithorax on the correct surgical side will be identified and the skin prepared with 2% chlorhexidine in 70% alcohol. In a sterile fashion, using a 10-15MHz US-probe an anaesthetist proficient in the technique will identify the transverse process of the 5th-7th thoracic vertebrae. Muscles layers of trapezius, rhomboid major and erector spinae will be visualized and utilizing an in-plane technique a 16/18G Touhey needle will be inserted until it comes in contact with the transverse process which it the most posterior border of the fascial plane below the erector spinae muscle. An initial bolus dose of 20mL of 0.375% ropivicaine will be injected and the spread of local anaesthetic within the plane confirmed with US. Through the needle a multi-orifice catheter will be inserted and placed in the fascial plane to a depth of 3cm. It’s position will be confirmed by injecting 5mL of 0.375% ropivicaine down the catheter under US-guidance. Catheter will be secured in an appropriate technique by the anaesthetist placing the block.

On average it is expected to take between 15-30 minutes to perform this block. Patients will then proceed to the operating theatre to have their VATS procedure. At the end of their operation a further 10mL of 0.375% ropivicaine will be given down the catheter prior to their arrival in PACU. It is anticipated that the catheter will remain in-situ for 2/7 with an hourly 10mL bolus of 0.2% ropivicaine.
Intervention code [1] 301427 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306147 0
Perioperative Analgesia using an objective measure of block efficacy by assessing dermatomal levels covered in PACU, D1 and D2, along with a subjective questionnaire of pain scores at rest and with movement using a verbal numerical rating score along with a functional activity score.
Timepoint [1] 306147 0
Intra-operatively ... Post-Anaesthetic Care Unit ... Post-operative Day 1 [primary timepoint] ... Post-operative Day 2 ... and Post-operative Day 3 if patient remains in the hospital.
Primary outcome [2] 306148 0
Plasma Pharmacokinetic Profile of 20mL 0.375% Ropivicaine injected into the Erector Spinae Plane - with a world-class team of pharmcometricians using an 80% power assessment of covariates (weight, gender, age, height, alpha-1-acid glycoprotein) associated with the pharmockinetics of ropivicaine (CL, Vd, protein binding, elimination half life - however we will be guided by our pharmacometrics team if further analysis is required) will be assessed. Then this data will be analysed using PMetrics and Monte-carlo simulation to create a simulated population of 1000 patients to allow a complete assessment of the pharmacokinetic profile of 0.375% ropivicaine injected into the Erector Spinae Plane.
Timepoint [2] 306148 0
T - minus 5 minutes, T - 5 minutes, T - 30 minutes, T - 60 minutes and T - 120 minutes
Primary outcome [3] 307276 0
Analgesic effect of the ESB using opioid consumption as a surrogate marker (each patient will have a standardized regimen of long acting opiates as well as an oxycodone PCA and once the PCA is removed PRN oxycodone - this data of additional oxycodone requirements will be converted to an equivalent iv dose and reported as mcg used)
Timepoint [3] 307276 0
Post-operative day 3 - cumulative totals for the first 48 hours will be recorded and undergo statistical assessment.
Secondary outcome [1] 347733 0
Chronic Post Surgical Pain Syndrome - patients undergoing thoracic surgery are a high risk of this complication and thus we will review long-term patient analgesia. Patients will be contacted 12 months post their VAT procedure and asked to fill in and return a brief pain inventory questionnaire.
Timepoint [1] 347733 0
12 months post procedure

Eligibility
Key inclusion criteria
Patients undergoing elective Video-Assisted Thoracic Surgery at the Royal Brisbane and Women's Hospital and The Prince Charles Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anatomical Contraindications to Placement of Erector Spinae Block
Surgical Contraindications to Placement of Erector Spinae Block
Pharmacological or physiological coagulation deficit outside of accepted regional anaesthetic guidelines for placement of fascial plane blocks
Known or suspected adverse reaction to amide local anaesthetics
Acute or chronic renal disease
Acute or chronic liver dysfunction

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)
Allocation is not concealed
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
Prospective Cohort Study
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed using a propriety statistical package (STATA version 12.0). Data will be organised and trends reported using standard descriptive statistics (mean (SD), median (IRG), proportions). More detailed inferential analysis will be done using regression techniques that take into account the linear and correlated nature of the data.

For the pharmacokinetics assessment of ropivicaine PMetrics® software will be used to produce population pharmacokinetic modelling. Regression analysis will be employed to statistically validate these models, This can then be used to perform Monte Carlo dosing simulations to determine if current dosing regimens achieve adequate drug concentrations, or which optimised dosing regimens could be used for ESB in future studies.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/09/2018
Actual
Date of last participant enrolment
Anticipated
1/07/2019
Actual
Date of last data collection
Anticipated
3/01/2021
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11069 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 11070 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 22872 0
4029 - Herston
Recruitment postcode(s) [2] 22873 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 299675 0
Hospital
Name [1] 299675 0
Royal Brisbane and Women's Hospital Anaesthetic Research Department
Country [1] 299675 0
Australia
Primary sponsor type
Hospital
Name
RBWH Anaesthetic Department
Address
C/O Anaesthetic Research Department
Royal Brisbane and Women's Hospital
Cnr of Bowen Bridge Road and Butterfield Street
Herston
Queensland
4029
Country
Australia
Secondary sponsor category [1] 299009 0
Individual
Name [1] 299009 0
Dwane Jackson
Address [1] 299009 0
C/O Anaesthetic Research Department
Royal Brisbane and Women's Hospital
Cnr of Bowen Bridge Road and Butterfield Street
Herston
Queensland
4029
Country [1] 299009 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300574 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 300574 0
C/O The Prince Charles Hospital
627 Rode Road
Chermside
Queensland
4032
Ethics committee country [1] 300574 0
Australia
Date submitted for ethics approval [1] 300574 0
13/08/2018
Approval date [1] 300574 0
Ethics approval number [1] 300574 0

Summary
Brief summary
Video-assisted Thorascopic Surgery (VATS) is a common painful surgical procedure for which there is no broadly acceptable choice of regional analgesia which is effective, safe and technically less demanding than neuraxial procedures. The erector spinae block is a novel interfascial plane block that has shown promise in case studies and anecdotally within our department. The purpose of this initial cohort trial is to assess the efficacy and safety of the erector spinae block as a means of peri-operative analgesia in patients undergoing VATS procedures.
Trial website
Trial related presentations / publications
Public notes
This Prospective Cohort Series currently has no control group per se but at a later date the data obtained may be compared to current standard practice over the previous 24 months

Contacts
Principal investigator
Name 84098 0
Dr Dwane Jackson
Address 84098 0
C/O Anaesthetic Department
Royal Brisbane and Women's Hospital
Cnr of Bowen Bridge Road and Butterfield Street
Herston
Queensland
4029
Country 84098 0
Australia
Phone 84098 0
+61 7 36468111
Fax 84098 0
Email 84098 0
[email protected]
Contact person for public queries
Name 84099 0
Dr Dwane Jackson
Address 84099 0
C/O Anaesthetic Department
Royal Brisbane and Women's Hospital
Cnr of Bowen Bridge Road and Butterfield Street
Herston
Queensland
4029
Country 84099 0
Australia
Phone 84099 0
+61 7 36468111
Fax 84099 0
Email 84099 0
[email protected]
Contact person for scientific queries
Name 84100 0
Dr Dwane Jackson
Address 84100 0
C/O Anaesthetic Department
Royal Brisbane and Women's Hospital
Cnr of Bowen Bridge Road and Butterfield Street
Herston
Queensland
4029
Country 84100 0
Australia
Phone 84100 0
+61 7 36468111
Fax 84100 0
Email 84100 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
No additional documents have been identified.