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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2021-11-22

Brief Summary

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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

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Detailed Description

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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

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Lung Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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).

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Paravertebral Block (PVB)

Intervention Type 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.

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

Group Type EXPERIMENTAL

Erector Spinae Plane Block (ESPB)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No