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Poor recruiting and transfer of the PI to another center
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral block (PVB) | Active Comparator | Intraoperative pain management
Post operative pain management
|
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| Erector Spinae Plane Block (ESPB) | Experimental | Intraoperative pain management
Post operative pain management
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paravertebral Block (PVB) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation of systemic anesthetics during the procedure | Percentage of patients who need sedation escalation | 1 hour from the end of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain perception | 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 | 8, 16, 24 hours from the end of procedure |
| Post operative pain management |
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacro Cuore - Don Calabria Hospital | Negrar | Verona | 37024 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15511470 | Background | Pompeo E, Mineo D, Rogliani P, Sabato AF, Mineo TC. Feasibility and results of awake thoracoscopic resection of solitary pulmonary nodules. Ann Thorac Surg. 2004 Nov;78(5):1761-8. doi: 10.1016/j.athoracsur.2004.05.083. | |
| 24585550 | Background | Hung MH, Hsu HH, Chan KC, Chen KC, Yie JC, Cheng YJ, Chen JS. Non-intubated thoracoscopic surgery using internal intercostal nerve block, vagal block and targeted sedation. Eur J Cardiothorac Surg. 2014 Oct;46(4):620-5. doi: 10.1093/ejcts/ezu054. Epub 2014 Feb 28. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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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).
|
| Erector Spinae Plane Block (ESPB) | Procedure | 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. |
|
Number of extra doses of rescue analgesia during the first 24 hours after the procedure. |
| 8, 16, 24 hours from the end of procedure |
| 27165771 | Background | Liu J, Cui F, Pompeo E, Gonzalez-Rivas D, Chen H, Yin W, Shao W, Li S, Pan H, Shen J, Hamblin L, He J. The impact of non-intubated versus intubated anaesthesia on early outcomes of video-assisted thoracoscopic anatomical resection in non-small-cell lung cancer: a propensity score matching analysis. Eur J Cardiothorac Surg. 2016 Nov;50(5):920-925. doi: 10.1093/ejcts/ezw160. Epub 2016 May 10. |
| 26449303 | Background | Broseta AM, Errando C, De Andres J, Diaz-Cambronero O, Ortega-Monzo J. Serratus plane block: the regional analgesia technique for thoracoscopy? Anaesthesia. 2015 Nov;70(11):1329-30. doi: 10.1111/anae.13263. No abstract available. |
| 27501016 | Background | Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. |
| 27242357 | Background | Scarfe AJ, Schuhmann-Hingel S, Duncan JK, Ma N, Atukorale YN, Cameron AL. Continuous paravertebral block for post-cardiothoracic surgery analgesia: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2016 Dec;50(6):1010-1018. doi: 10.1093/ejcts/ezw168. Epub 2016 May 30. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |