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

Not Applicable

Completed

• Conditions: Post Operative Pain; Thoracic Cancer
• Interventions: Procedure: Paravertebral block with methylene blue; Procedure: Thoracic Epidural Anesthesia

• Registration Number: NCT05812521
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2020-01-15
• Primary Completion: 2022-11-20
• Study Completion: 2022-12-16
• Study First Submitted: 2023-03-19
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-02
• Last Update Submitted: 2023-04-02
• Study First Posted: 2023-04-13
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paravertebral block with methylene blue	Paravertebral block with methylene blue	With the patient sitting, the patient will receive paravertebral block at T4-T5 level before general anesthesia induction
Thoracic Epidural Anesthesia	Thoracic Epidural Anesthesia	With the patient sitting, the patient will receive thoracic epidural anesthesia at T4-T8 level before general anesthesia induction

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Scores on the Postoperative Numeric Rating Scale in the first 48 hours postoperatively	1 hours, 12 hours, 24 hours and 48 hours after surgery	Pain scores at rest and after cough will be evaluated in the first 48 hours postoperatively using Postoperative Numeric Rating Scale (NRS) ranging from 0 (absence of pain) to 10 (maximum level of pain)

Secondary Outcome Measures

Name	Time	Method
Opioids consumption	through the entire hospital stay, an average of 8 days"	Cumulative dose of intravenous opioids administered as rescue analgesic will be registered during the post-operative period.
Time to perform PVB or TEA	From the identification of the site of injection to the start of general anesthesia, up to 1 hour	Time needed to perform PVB or TEA will be recorded
Chest tube duration	From chest tube placement to chest tube removal, up to 20 days	Total days of chest tube duration will be recorded
Length of hospital stay	From hospital admission to discharge, up to 20 days	Total days of hospital stay will be recorded

Trial Locations

Locations (1)

Alfonso Fiorelli; 🇮🇹 Naples, Italy