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

NCT05812521 | Completed

• 1 other identifier: 29917/2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Thoracic Cancer

Keywords

postoperative pain; regional anesthesia; thoracoscopy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain Scores on the Postoperative Numeric Rating Scale in the first 48 hours postoperatively

  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 Outcomes (4)

• Opioids consumption

  through the entire hospital stay, an average of 8 days"

• Time to perform PVB or TEA

  From the identification of the site of injection to the start of general anesthesia, up to 1 hour

• Chest tube duration

  From chest tube placement to chest tube removal, up to 20 days

• Length of hospital stay

  From hospital admission to discharge, up to 20 days

Study Arms (2)

Paravertebral block with methylene blue

EXPERIMENTAL

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

Procedure: Paravertebral block with methylene blue

Thoracic Epidural Anesthesia

ACTIVE COMPARATOR

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

Procedure: Thoracic Epidural Anesthesia

Interventions

Paravertebral block with methylene blue PROCEDURE

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.

Paravertebral block with methylene blue

Thoracic Epidural Anesthesia PROCEDURE

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.

Thoracic Epidural Anesthesia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Alfonso Fiorelli

Naples, 84100, Italy

Location

Related Publications (8)

• Yeap YL, Wolfe JW, Backfish-White KM, Young JV, Stewart J, Ceppa DP, Moser EAS, Birdas TJ. Randomized Prospective Study Evaluating Single-Injection Paravertebral Block, Paravertebral Catheter, and Thoracic Epidural Catheter for Postoperative Regional Analgesia After Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2020 Jul;34(7):1870-1876. doi: 10.1053/j.jvca.2020.01.036. Epub 2020 Jan 25.

  PMID: 32144059 BACKGROUND

• D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.

  PMID: 29169795 BACKGROUND

• Norum HM, Breivik H. A systematic review of comparative studies indicates that paravertebral block is neither superior nor safer than epidural analgesia for pain after thoracotomy. Scand J Pain. 2010 Jan 1;1(1):12-23. doi: 10.1016/j.sjpain.2009.10.003.

  PMID: 29913936 BACKGROUND

• Baidya DK, Khanna P, Maitra S. Analgesic efficacy and safety of thoracic paravertebral and epidural analgesia for thoracic surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2014 May;18(5):626-35. doi: 10.1093/icvts/ivt551. Epub 2014 Jan 31.

  PMID: 24488821 BACKGROUND

• Casati A, Alessandrini P, Nuzzi M, Tosi M, Iotti E, Ampollini L, Bobbio A, Rossini E, Fanelli G. A prospective, randomized, blinded comparison between continuous thoracic paravertebral and epidural infusion of 0.2% ropivacaine after lung resection surgery. Eur J Anaesthesiol. 2006 Dec;23(12):999-1004. doi: 10.1017/S0265021506001104. Epub 2006 Jul 7.

  PMID: 16824243 BACKGROUND

• Helms O, Mariano J, Hentz JG, Santelmo N, Falcoz PE, Massard G, Steib A. Intra-operative paravertebral block for postoperative analgesia in thoracotomy patients: a randomized, double-blind, placebo-controlled study. Eur J Cardiothorac Surg. 2011 Oct;40(4):902-6. doi: 10.1016/j.ejcts.2011.01.067. Epub 2011 Mar 5.

  PMID: 21377888 BACKGROUND

• 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.

  PMID: 24797238 BACKGROUND

• Marshall K, McLaughlin K. Pain Management in Thoracic Surgery. Thorac Surg Clin. 2020 Aug;30(3):339-346. doi: 10.1016/j.thorsurg.2020.03.001. Epub 2020 Apr 29.

  PMID: 32593366 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alfonso Fiorelli, MD, PhD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: April 13, 2023
• Study Start: January 15, 2020
• Primary Completion: November 20, 2022
• Study Completion: December 16, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)