None listed
Conditions
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.
Interventions
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 cathe
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.
Sponsors
Westmead Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
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
Outcome results
None listed