Clinical trial NCT05812521: Thoracic Paravertebral Block With Methylene Blue Visual Confirmation for Postoperative Pain After VATS Lobectomy
Official title: Efficacy of Thoracic Paravertebral Block With Methylene Blue Visual Confirmation in the Management of Postoperative Pain After Video-assisted Thoracoscopic Lobectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Thoracic Cancer
Keywords: postoperative pain
regional anesthesia
thoracoscopy
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Pain Scores on the Postoperative Numeric Rating Scale in the first 48 hours postoperatively
timeFrame: 1 hours, 12 hours, 24 hours and 48 hours after surgery
Secondary outcomes:
measure: Opioids consumption
timeFrame: through the entire hospital stay, an average of 8 days"
measure: Time to perform PVB or TEA
timeFrame: From the identification of the site of injection to the start of general anesthesia, up to 1 hour
measure: Chest tube duration
timeFrame: From chest tube placement to chest tube removal, up to 20 days
measure: Length of hospital stay
timeFrame: From hospital admission to discharge, up to 20 days
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Alfonso Fiorelli
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Alfonso Fiorelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ding X, Jin S, Niu X, Ren H, Fu S, Li Q. A comparison of the analgesia efficacy and side effects of paravertebral compared with epidural blockade for thoracotomy: an updated meta-analysis. PLoS One. 2014 May 5;9(5):e96233. doi: 10.1371/journal.pone.0096233. eCollection 2014.
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