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

April 2, 2023 updated by: Alfonso Fiorelli, University of Campania "Luigi Vanvitelli"

Efficacy of Thoracic Paravertebral Block With Methylene Blue Visual Confirmation in the Management of Postoperative Pain After Video-assisted Thoracoscopic Lobectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 84100
        • Alfonso Fiorelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paravertebral block with methylene blue
With the patient sitting, the patient will receive paravertebral block at T4-T5 level before general anesthesia induction
Procedure: Paravertebral block with methylene blue
The paravertebral space is identified under ultrasound guidance and after negative aspiration a 3 ml test dose of anesthetic is injected. After observing widening of the paravertebral space and anterior pleural displacement to confirm the correct needle positioning, a bolus dose of 20 mL 0.5% ropivacaine with a solution of 1 ml 1% methylene blue and 4 ml of saline will be injected in the paravertebral space. At the start of the surgery, the spread of the solution of anesthetic and methylene blue will be assessed through visualization in thoracoscopy and if necessary the block will be repeated. After the surgery, intravenous acetaminophen will be administered 3 times daily and tramadol 50 mg will be prescribed as rescue analgesic.
Active Comparator: Thoracic Epidural Anesthesia
With the patient sitting, the patient will receive thoracic epidural anesthesia at T4-T8 level before general anesthesia induction
Procedure: Thoracic Epidural Anesthesia
The epidural catheter will be placed using the loss of resistance technique, and after ruling out intravenous or intrathecal catheter placement with a negative aspiration test dose, an initial dose of 10 mL 0.25% bupivacaine will be injected. Continuous infusion will be started with with 0.125 % bupivacaine + fentanyl 0.5 mcg/ ml at 6-10 ml/hour will be started based on the patient weight for 48 hours postoperatively. After the surgery, intravenous acetaminophen will be administered 3 times daily and tramadol 50 mg will be prescribed as rescue analgesic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pain Scores on the Postoperative Numeric Rating Scale in the first 48 hours postoperatively
Time Frame: 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)
1 hours, 12 hours, 24 hours and 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioids consumption
Time Frame: 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.
through the entire hospital stay, an average of 8 days"
Time to perform PVB or TEA
Time Frame: 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
From the identification of the site of injection to the start of general anesthesia, up to 1 hour
Chest tube duration
Time Frame: From chest tube placement to chest tube removal, up to 20 days
Total days of chest tube duration will be recorded
From chest tube placement to chest tube removal, up to 20 days
Length of hospital stay
Time Frame: From hospital admission to discharge, up to 20 days
Total days of hospital stay will be recorded
From hospital admission to discharge, up to 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Investigators

  • Principal Investigator: Alfonso Fiorelli, MD, PhD, University of Campania "Luigi Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Actual)

November 20, 2022

Study Completion (Actual)

December 16, 2022

Study Registration Dates

First Submitted

March 19, 2023

First Submitted That Met QC Criteria

April 2, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29917/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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