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Trial registered on ANZCTR


Registration number
ACTRN12617001125314p
Ethics application status
Submitted, not yet approved
Date submitted
18/07/2017
Date registered
1/08/2017
Date last updated
1/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing efficacy of analgesia with Serratus Anterior Plane Catheter vs Surgical Paravertebral Catheter for Thoracotomy – A Non Inferiority RCT (SAP RCT)
Scientific title
Comparing efficacy of analgesia with Serratus Anterior Plane Catheter vs Surgical Paravertebral Catheter for Thoracotomy – A Non Inferiority RCT (SAP RCT)
Secondary ID [1] 292456 0
None
Universal Trial Number (UTN)
U1111-1199-4291
Trial acronym
SAP RCT
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
thoracic surgery 304070 0
post operative pain 304071 0
Condition category
Condition code
Anaesthesiology 303407 303407 0 0
Pain management
Surgery 303440 303440 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A new regional technique for analgesia of chest wall, called serratus anterior plane block catheter. Serratus anterior plane block is a fascial plane block achieved by injection of local anaesthesia into the fascia plane either just superficial to serratus anterior muscle or just deep to the serratus anterior muscle. The local anaesthesia will inhibit branches of intercostal nerves supplying the hemithorax.

At the end of the surgery but prior to extubation, the anaesthetist will insert a catheter into the serratus anterior plane and bolus 50ml 0.2% ropivocaine (100mg). After extubation and being stabilised in Post Anaesthetic Care Unit, the PACU nurse will connect the catheter to a peripheral nerve infusion pump. For the next 48hours, the infusion pump will bolus 40ml 0.2% ropivocaine every 4hours. This is consistent with current practice of serratus anterior infusion catheter management at this hospital.
Intervention code [1] 298635 0
Treatment: Drugs
Comparator / control treatment
Surgically placed paravertebral catheter. Surgeons can under direct vision during the operation open the paravertebral space and place a catheter into it. Local anaesthesia is injected into the paravertebral space to achieve anaesthesia of the hemithorax by blocking the spinal nerves.


At the end of the surgery but prior to extubation, the surgeon will insert a catheter into the paravertebral space and bolus 20ml 0.5% ropivocaine (100mg ropivocaine). After extubation and being stabilised in Post Anaesthetic Care Unit, the PACU nurse will connect the catheter to a peripheral nerve infusion pump. For the next 48hours, the infusion pump will infuse 10ml 0.2% ropivocaine per hour. This is consistent with current practice of surgically placed paravertebral catheter management at this hospital. Over the 48 hour both groups will receive the same total dose of ropivocaine.
Control group
Active

Outcomes
Primary outcome [1] 302786 0
Fentanyl PCA (Patient Controlled Analgesia) use in first 24hours recorded by the nurses on the PCA chart.
Timepoint [1] 302786 0
24 hours postoperatively
Secondary outcome [1] 336994 0
Fentanyl PCA (Patient Controlled Analgesia) use in first 48hours recorded by the nurses on the PCA chart.
Timepoint [1] 336994 0
48hours post operatively
Secondary outcome [2] 336995 0
Pain score at rest in first 24 hours, using Numerical Rating Scale reported by patient
Timepoint [2] 336995 0
First 24 hours post operatively
Secondary outcome [3] 337032 0
Time taken to perform US guided serratus anterior catheter in minutes, timed by a nurse observing the procedure using stopwatch. Timing starts after the anaesthetist has scrubbed for the procedure and ends upon finishing injection of initial local anaesthetic bolus.
Timepoint [3] 337032 0
Intraoperative
Secondary outcome [4] 337033 0
Mortality
Timepoint [4] 337033 0
Duration of admission
Secondary outcome [5] 337152 0
Local anaesthetic toxicity assessed by history taking (looking for neurological symptoms including perioral numbness and tingling, hallucinations, diplopia, decreased level of consciousness using GCS; and cardiovascular symptoms including arrhythmias, bradycardia, hypotension, ECG changes). If local anaesthetic toxicity is suspected, then serum sample is sent for ropivocaine levels. However this assay is not performed on the index hospital and due to long turn around time, it will be used to confirm local anaesthetic toxicity when suspected rather than diagnosing local anaesthetic toxicity.
Timepoint [5] 337152 0
Duration of hospital stay
Secondary outcome [6] 337154 0
Catheter related adverse events: localised infection, localised haematoma, local skin reaction, catheter malfunction and dislodgement prior to planned removal by review of medical records.
Timepoint [6] 337154 0
First 48 hours post operatively
Secondary outcome [7] 337155 0
Opioid side effects by review of medical records.
Timepoint [7] 337155 0
First 48 hours post operatively
Secondary outcome [8] 337156 0
Cardiovascular complications: hypotension; arrhythmia, bradycardia, major adverse cardiac event by review of medical records.
Timepoint [8] 337156 0
First 48hours post operatively
Secondary outcome [9] 337157 0
Respiratory complications: respiratory depression, hypoxia, NIV or re-intubation by review of medical records.
Timepoint [9] 337157 0
First 48 hours post operatively
Secondary outcome [10] 337158 0
Unintended ICU admission by review of medical records.
Timepoint [10] 337158 0
First 48 hours post operatively
Secondary outcome [11] 337160 0
Length of hospital stay by review of medical records.
Timepoint [11] 337160 0
Duration of admission
Secondary outcome [12] 337280 0
Pain score with coughing in first 24 hours, using Numerical Rating Scale reported by patient
Timepoint [12] 337280 0
First 24 hours post operatively
Secondary outcome [13] 337281 0
Pain score at rest, using Numerical Rating Scale reported by patient
Timepoint [13] 337281 0
First 48 hours post operatively
Secondary outcome [14] 337282 0
Pain score with coughing, using Numerical Rating Scale reported by patient
Timepoint [14] 337282 0
First 48 hours post operatively

Eligibility
Key inclusion criteria
• Elective and non-emergency open thoracic surgery requiring posterolateral muscle sparing thoracotomy incision without chest wall resection for pneumonectomy, bullectomy, lobectomy, segementectomy, wedge resection, pleurodesis and other lung surgeries
• Able to understand study information and provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• <18years old; >80years old
• Weight <50kg as patients under 50kg require dose adjustment to local anaesthesia infusion regime
• Thoracotomy for non pulmonary procedures e.g. minimally invasive CABG, epicardial lead placement, pericardial window formation and drainage of pericardial effusion, mediastinal mass surgery, oesophagectomy
• Known allergy to local anaesthetic
• History of opioid tolerance (defined as daily opioid use higher than 50mg oral morphine equivalent in the previous 2 months*)
• History of chronic pain
• Acute psychiatric illness other than depression or anxiety
• Inability to use PCA
• Inability to understand numerical pain scale

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)
Patients will be allocated by a separate person who is not involved in recruitment or data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation in permutated blocks of unequal length
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Primary Outcome: The primary outcome is analgesic effect of SAPB catheter is not inferior to sPVB catheter with the largest clinically acceptable difference being 150mcg fentanyl in first 24h post open thoracotomy. The approach we will use to analyse this trial is to first pre-define the smallest level of inferiority of the proposed treatment (150 mcg fentanyl), which, if surpassed, would be a clinically unacceptable difference. To conduct the actual analysis we’ll construct the CI of the difference between treatments and observe if the span of the CI lies completely on one side of delta (in the more favourable direction for the new treatment).

Recruitment
Recruitment status
Not yet recruiting
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 in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8554 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 16658 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 297024 0
Hospital
Name [1] 297024 0
Department of Anaesthesia, Westmead Hospital
Address [1] 297024 0
Department of Anaesthesia
Westmead Hospital
Cnr Darcy Rd and Hawkesbury Rd
Westmead NSW 2145
Country [1] 297024 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Cnr Darcy Rd and Hawkesbury Rd
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 296027 0
None
Name [1] 296027 0
Address [1] 296027 0
Country [1] 296027 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298209 0
WSLHD HREC
Ethics committee address [1] 298209 0
Westmead Research Office
Research & Education Network bldg
Westmead Hospital
Darcy Road
Westmead NSW 2145
Ethics committee country [1] 298209 0
Australia
Date submitted for ethics approval [1] 298209 0
19/07/2017
Approval date [1] 298209 0
Ethics approval number [1] 298209 0

Summary
Brief summary
Aim

The aim of this non-inferiority randomised controlled trial is to investigate a regional technique that is as efficacious in analgesia as paravertebral block (PVB) and thoracic epidural analgesia (TEA) for open thoracic surgery using postero-lateral thoracotomy incision, but less invasive and easier to perform.

Hypothesis

We hypothesise that Serratus Anterior Plane Block (SAPB) catheter provides non-inferior analgesia compared to surgically placed Paravertebral Block (sPVB) catheter in open postero-lateral thoracotomy, with the largest clinically acceptable difference of 150mcg fentanyl in first 24h post operatively.

Specific objectives

1. To demonstrate that analgesic effects of SAPB catheter is not inferior to surgically placed PVB catheter in open postero-lateral thoracotomy
2. To demonstrate that SAPB is a minimally invasive, safe and easy to perform alternative to PVB

Method

This trial will be a single centre non-inferiority, pragmatic, randomised controlled trial (RCT) with 2 parallel groups and 1:1 allocation comparing efficacy of analgesia of SAPB catheters to sPVB catheters for elective open postero-lateral thoracotomy.

Significance

Open thoracotomy is one of the most painful surgical incisions. Effective analgesia is imperative to good postoperative outcomes but it is difficult to achieve. A multitude of regional techniques have been developed however no one technique is safe and efficacious for all patients. The two current gold standard of post thoracotomy analgesia, PVB and TEA, are associated with significant barriers including side effects, complications, contra-indications and technical challenges.

SAPB is a relatively new but promising technique that in healthy volunteers and cadaveric models was able to achieve paraesthesia of the ipsilateral hemithorax with few side effects. However the clinical efficacy of SAPB is not well established. SAPB can potentially provide similar analgesia to PVB and TEA for thoracic surgery but with improved safety profile and easier learning curve; this would represent a significant advancement in post thoracotomy analgesia.

Likely benefits

An effective yet minimally invasive regional technique with few side effects will be a safer alternative to thoracic epidurals and paravertebrals for thoracic surgery. Furthermore it may be particularly useful in ambulatory surgery and as a rescue technique.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76346 0
Dr Lei Lei
Address 76346 0
Department of Anaesthesia
Westmead Hospital
Cnr Darcy Rd and Hawkesbury Rd
Westmead NSW 2145
Country 76346 0
Australia
Phone 76346 0
+61410887380
Fax 76346 0
Email 76346 0
lei.lei@health.nsw.gov.au
Contact person for public queries
Name 76347 0
Dr Lei Lei
Address 76347 0
Department of Anaesthesia
Westmead Hospital
Cnr Darcy Rd and Hawkesbury Rd
Westmead NSW 2145
Country 76347 0
Australia
Phone 76347 0
+61410887380
Fax 76347 0
Email 76347 0
lei.lei@health.nsw.gov.au
Contact person for scientific queries
Name 76348 0
Dr Lei Lei
Address 76348 0
Department of Anaesthesia
Westmead Hospital
Cnr Darcy Rd and Hawkesbury Rd
Westmead NSW 2145
Country 76348 0
Australia
Phone 76348 0
+61410887380
Fax 76348 0
Email 76348 0
lei.lei@health.nsw.gov.au

No data has been provided for results reporting
Summary results
Not applicable