Lung Neoplasms
Conditions
Keywords
Awake Thoracic Surgery, Erector Spinae Plane Block
Brief summary
A randomized prospective trial to test the non-inferiority of Erector Spinae Plane Block (ESPB) in comparison with paravertebral block during non-intubated thoracoscopic lung resection
Detailed description
A prospective randomized trial which aims to evaluate a new technique of peripheral nerve block for pain management, the Erector Spinae Plane Block (ESPB) in patients undergoing minimally invasive lung resection in spontaneous breathing, with intravenous sedation (non-intubated thoracic surgery). ESPB will be compared with a largely employed procedure for loco regional pain management: the Paravertebral block (PB). Both procedures are performed under ultrasonographic guidance to allow proper visualization of the target site. Surgery is carried out by means of a minimally invasive approach (Video Assisted thoracic Surgery) with two keyhole incisions on the affected side.
Interventions
PROCEDUREParavertebral Block (PVB)
PVB consists in the injection of low concentration Ropivacaine (30 ml, 0.3%) in the paravertebral space (defined by the anterior aspect of the ribs, the vertebral body and the parietal pleura. The space is identified under ultrasonographic guidance by a dedicated Anesthesiologist.
PROCEDUREErector Spinae Plane Block (ESPB)
ESPB consists in the injection of low concentration Ropivacaine (30 ml, 0.3%), in the anatomical plane between the Erector Spinae muscles and deeper surface of Rhomboid muscle. The space is identified under ecographic guidance, laterally to the spinous process of T5. The diffusion of the anesthetic solution along the space can be echographically appreciated.
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Partecipant masking: Both blocks are performed on the area between the scapula and the vertebral column, employing the same materials, so that the patient is masked about which block is going to be performed. Care providers: once the block has been performed, a different anesthesiologist will take care of the patient during the procedure, eventually providing dose escalation in systemic analgesic drugs (primary end point). Surgeons performing the procedure are unaware of the type of block. Staff nurses managing post operative pain in terms of both recording (Numeric Rating Scale) and soothing (rescue analgesia distribution) are unaware of the type of block (secondary end points).
Intervention model description
Eligible patients will be randomized between two groups according to loco regional pain management: Paravertebral block Erector Spinae Plane Block Allocation to one treatment group or another will be randomized with the aim of create two unbiased groups formed out of the same group of patients. Randomization will be provided by a software.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Wedge Resection of pulmonary nodules performed with a two-portal or three-portal VATS approach. Peripheral (within 3 cm from the surface of the inflated lung) nodules, less than 2 cm in diameter. Acceptance of awake VATS with written informed consent
Exclusion criteria
Age \< 18 years Patients who are pregnant or lactating Morbid obesity (BMI \> 35 ) Inability to understand and sign the Informed consent Proven allergy to local anesthetic drugs as required by this protocol Expected pleural adhesions (previous thoracic trauma, previous pleuro-pulmonary infection, redo surgery on the affected side)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation of systemic anesthetics during the procedure | 1 hour from the end of the procedure | Percentage of patients who need sedation escalation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain perception | 8, 16, 24 hours from the end of procedure | Peak pain perception in three time frames (eight hours each) starting from the end of the procedure and covering the first 24 hours after the procedure |
| Post operative pain management | 8, 16, 24 hours from the end of procedure | Number of extra doses of rescue analgesia during the first 24 hours after the procedure. |
Countries
Italy
Outcome results
None listed