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

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

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.

It had two arms (groups): Paravertebral block with methylene blue (experimental) and Thoracic Epidural Anesthesia (active comparator).

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

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

The registry classes the interventions as procedure.

More on the Plan

The management of postoperative pain in patients undergoing thoracoscopic lobectomy is a fundamental part of the process of recovery.

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.

Participants will be randomly assigned in a 1:1 ratio to receive either PVB with methylene blue or TEA.

Who Took Part

120 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and females aged 18 - 85 years old. Scheduled to undergo thoracoscopic lobectomy for lung cancer. Standardized three-port anterior thoracoscopic approach.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: allergy to any of the drugs used in the study; previous thoracic surgical procedures or lung resection; psychiatric disorders.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2020-01-15 with completion listed for 2022-11-20.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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).

It also tracked 4 secondary outcomes, for example Opioids consumption, Time to perform PVB or TEA, Chest tube duration and Length of hospital stay.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 120 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.