Clinical trial · Interventional
Erector Spinae Plane Block Versus Paravertebral Block During Non-intubated Thoracoscopic Lung Resections.
Pain Blocks in Awake Thoracic Surgery: A Randomized Prospective Trial to Test the Non-inferiority of Erector Spinae Plane Block (ESPB) in Comparison With Paravertebral Block During Non-intubate, Thoracoscopic Lung Resection.
NCT03137576CI-TRIAL-00058411PABATSterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor recruiting and transfer of the PI to another center
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erector Spinae Plane Block (ESPB) | Procedure | — | UNRESOLVED |
| Paravertebral Block (PVB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Paravertebral block (PVB)
- description
- Intraoperative pain management 1. Sedation Continuous monitoring of sedation with bispectral index. Sedation is achieved with propofol 1% (target bispectral index: 50-70), plus on-demand remifentanyl (50 mcg/ml in TCI, dose target Cet 2-8 ng/ml). 2. Paravertebral Block Post operative pain management * Continuous infusion of Tramadol 200 mg or Ketorolac 60 mg * Rescue analgesia with Morphine (0.1 mg/kg) a single time every 24 hours, and/or Tramadol 100 mg up to three times every 24 hours and/ or Ketorolac 30 mg up to three times every 24 hours
- interventionNames
- Procedure: Paravertebral Block (PVB)
- type
- EXPERIMENTAL
- label
- Erector Spinae Plane Block (ESPB)
- description
- Intraoperative pain management 1. Sedation Continuous monitoring of sedation with bispectral index. Sedation is achieved with propofol 1% (target bispectral index: 50-70), plus on-demand remifentanyl (50 mcg/ml in TCI, dose target Cet 2-8 ng/ml). 2. Erector Spinae Plane Block Post operative pain management * Continuous infusion of Tramadol 200 mg or Ketorolac 60 mg * Rescue analgesia with Morphine (0.1 mg/kg) a single time every 24 hours, and/or Tramadol 100 mg up to three times every 24 hours and/ or Ketorolac 30 mg up to three times every 24 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (6)
- BACKGROUNDPompeo 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. PMID 15511470
- BACKGROUNDHung 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. PMID 24585550
- BACKGROUNDLiu 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. PMID 27165771
- BACKGROUNDBroseta 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. PMID 26449303
- BACKGROUNDForero 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. PMID 27501016
- BACKGROUNDScarfe 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. PMID 27242357