Thoracic Paravertebral Block With Methylene Blue Visual Confirmation for Postoperative Pain After VATS Lobectomy

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Thoracic Cancer; Post Operative Pain

Treatments: Procedure: Paravertebral block with methylene blue; Procedure: Thoracic Epidural Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05812521

29917/2022

Details and patient eligibility

About

The goal of this study is to compare the efficacy in controlling postoperative pain of paravertebral block (PVB) with methylene blue visual confirmation and thoracic epidural anesthesia (TEA). This is a single center, parallel-group, prospective study. Patients will be randomly assigned in a 1:1 ratio to receive either PVB or TEA. Primary end-point is pain relief measured with Postoperative Numeric Rating Scale. The secondary end-points are time to perform TEA and PVB, total opioid consumption, postoperative outcomes.

Full description

The management of postoperative pain in patients undergoing thoracoscopic lobectomy is a fundamental part of the process of recovery. Uncontrolled thoracic pain in the early postoperative period may interfere with the mobilization of the patients, leading to increased morbidity and reduction in the quality of life.

Thoracic paravertebral block (PVB) is an effective strategy for controlling postoperative pain after video-assisted thoracoscopic (VATS) lobectomy, but it may be subjected to a high rate of failure due to incorrect identification of the site of local anesthetic injection.

Thoracic epidural anesthesia (TEA) is considered a reliable technique for regional thoracic anesthesia, however potential side effects may limit its use.

Herein the investigators reported a new technique using methylene blue as a visual confirmation of the correct anesthetic diffusion during PVB. Then, the investigators will compare the efficacy of methylene blue PVB with TEA for the management of postoperative pain in patients undergoing VATS lobectomy.

This is a single center, parallel-group, prospective study. Participants will be randomly assigned in a 1:1 ratio to receive either PVB with methylene blue or TEA.

All participants will receive postoperatively intravenous acetaminophen as additional analgesics and intravenous tramadol as rescue analgesic. Primary end-point is pain relief measured with Postoperative Numeric Rating Scale at at 1, 12, 24, 48 hours postoperatively. The secondary end-points are: (i) time to perform TEA and PVB, (ii) total opioid consumption, (iii) postoperative outcomes (including complications, chest drainage duration and length of hospital stay).

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females aged 18 - 85 years old
• scheduled to undergo thoracoscopic lobectomy for lung cancer
• standardized three-port anterior thoracoscopic approach

Exclusion criteria

• Allergy to any of the drugs used in the study
• Previous thoracic surgical procedures or lung resection
• Psychiatric disorders
• ASA (American Society of Anesthesiologists) Class > III
• Conversion to thoracotomy
• Lack of written informed consent
• Participation to other studies
• Contraindications to epidural analgesia or paravertebral block

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Paravertebral block with methylene blue

Experimental group

Description:

With the patient sitting, the patient will receive paravertebral block at T4-T5 level before general anesthesia induction

Treatment:

Procedure: Paravertebral block with methylene blue

Thoracic Epidural Anesthesia

Active Comparator group

Description:

With the patient sitting, the patient will receive thoracic epidural anesthesia at T4-T8 level before general anesthesia induction

Treatment:

Procedure: Thoracic Epidural Anesthesia