Lung NeoplasmsPABATSNCT03137576
Erector Spinae Plane Block Versus Paravertebral Block During Non-intubated Thoracoscopic Lung Resections.
A study testing Paravertebral Block (PVB) and Erector Spinae Plane Block (ESPB) in people with Lung Neoplasms, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Paravertebral Block (PVB) and Erector Spinae Plane Block (ESPB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2019to 22 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
Read the 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.
- Conditions
- Lung Neoplasms
- Being tested
- Paravertebral Block (PVB), Erector Spinae Plane Block (ESPB)
- Keywords
- Awake Thoracic Surgery, Erector Spinae Plane Block
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral Block (PVB)Procedure or surgery
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.
Erector Spinae Plane Block (ESPB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block (PVB) | Active comparator | 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 Receives: Procedure: Paravertebral Block (PVB) |
| Erector Spinae Plane Block (ESPB) | Experimental | 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 Receives: Procedure: Erector Spinae Plane Block (ESPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation of systemic anesthetics during the procedure
Percentage of patients who need sedation escalation
Measured: 1 hour from the end of the procedure
Secondary outcomes (2)
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
Measured: 8, 16, 24 hours from the end of procedure
Post operative pain management
Number of extra doses of rescue analgesia during the first 24 hours after the procedure.
Measured: 8, 16, 24 hours from the end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start22 Feb 2019
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Why it stopped: Poor recruiting and transfer of the PI to another center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137576
- Sponsor's protocol ID
- CHT02
- Acronym
- PABATS
- Status last verified
- May 2022
- First submitted
- 28 Apr 2017
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15511470Hung 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.
PubMed 24585550Liu 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.
PubMed 27165771Broseta 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.
PubMed 26449303Forero 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.
PubMed 27501016Scarfe 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.
PubMed 27242357
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03137576
- Acronym / sponsor ID
- PABATS / CHT02
- Conditions
- Lung Neoplasms
- Keywords
- Awake Thoracic Surgery, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruiting and transfer of the PI to another center
- Enrolment
- 7 participants (actual)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block (PVB) | Active comparator | Procedure: Paravertebral Block (PVB)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 |
| Erector Spinae Plane Block (ESPB) | Experimental | Procedure: Erector Spinae Plane Block (ESPB)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paravertebral 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. | Procedure or surgery | Paravertebral block (PVB) |
| Erector 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. | Procedure or surgery | Erector Spinae Plane Block (ESPB) |
Primary outcome
Dose Escalation of systemic anesthetics during the procedure
Time frame: 1 hour from the end of the procedure
Percentage of patients who need sedation escalation
2 secondary outcomes
Post operative pain perception
Time frame: 8, 16, 24 hours from the end of procedure
Post operative pain management
Time frame: 8, 16, 24 hours from the end of procedure
Results and safety
The study was stopped early (reason given: Poor recruiting and transfer of the PI to another center). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 15511470Pompeo 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.
- Background: PubMed 24585550Hung 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.
- Background: PubMed 27165771Liu 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.
- Background: PubMed 26449303Broseta 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.
- Background: PubMed 27501016Forero 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.
- Background: PubMed 27242357Scarfe 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.
- Individual participant dataSharing planned: No
Related trials for Lung Neoplasms
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral Block (PVB) and Erector Spinae Plane Block (ESPB) in people with Lung Neoplasms, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruiting and transfer of the PI to another center). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation of systemic anesthetics during the procedure (time frame: 1 hour from the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137576, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.