Back to results

Erector Spinae Plane Block Versus Paravertebral Block During Non-intubated Thoracoscopic Lung Resections. (PABATS)

Primary Purpose

Lung Neoplasms

Status

Terminated

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Paravertebral Block (PVB)

Erector Spinae Plane Block (ESPB)

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Awake Thoracic Surgery, Erector Spinae Plane Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Sacro Cuore - Don Calabria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Paravertebral block (PVB)

Erector Spinae Plane Block (ESPB)

Arm Description

Intraoperative pain management 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). 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

Intraoperative pain management 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). 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

Outcomes

Primary Outcome Measures

Dose Escalation of systemic anesthetics during the procedure

Percentage of patients who need sedation escalation

Secondary Outcome Measures

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

Post operative pain management

Number of extra doses of rescue analgesia during the first 24 hours after the procedure.

Full Information

NCT ID

NCT03137576

First Posted

April 28, 2017

Last Updated

May 5, 2022

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

1. Study Identification

Unique Protocol Identification Number

NCT03137576

Brief Title

Erector Spinae Plane Block Versus Paravertebral Block During Non-intubated Thoracoscopic Lung Resections.

Acronym

PABATS

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Terminated

Why Stopped

Poor recruiting and transfer of the PI to another center

Study Start Date

February 22, 2019 (Actual)

Primary Completion Date

November 22, 2021 (Actual)

Study Completion Date

November 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms

Keywords

Awake Thoracic Surgery, Erector Spinae Plane Block

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare Provider

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).

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paravertebral block (PVB)

Arm Type

Active Comparator

Arm Description

Arm Title

Erector Spinae Plane Block (ESPB)

Arm Type

Experimental

Arm Description

Intraoperative pain management 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). 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

Intervention Type

Procedure

Intervention Name(s)

Paravertebral Block (PVB)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Erector Spinae Plane Block (ESPB)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Dose Escalation of systemic anesthetics during the procedure

Description

Percentage of patients who need sedation escalation

Time Frame

1 hour from the end of the procedure

Secondary Outcome Measure Information:

Title

Post operative pain perception

Description

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

Time Frame

8, 16, 24 hours from the end of procedure

Title

Post operative pain management

Description

Number of extra doses of rescue analgesia during the first 24 hours after the procedure.

Time Frame

8, 16, 24 hours from the end of procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Sacro Cuore - Don Calabria Hospital

City

Negrar

State/Province

Verona

ZIP/Postal Code

37024

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15511470

Citation

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.

Results Reference

background

PubMed Identifier

24585550

Citation

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.

Results Reference

background

PubMed Identifier

27165771

Citation

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.

Results Reference

background

PubMed Identifier

26449303

Citation

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.

Results Reference

background

PubMed Identifier

27501016

Citation

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.

Results Reference

background

PubMed Identifier

27242357

Citation

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.

Results Reference

background

Learn more about this trial

Erector Spinae Plane Block Versus Paravertebral Block During Non-intubated Thoracoscopic Lung Resections.

We'll reach out to this number within 24 hrs