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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Post Operative Pain, Thoracic Cancer

Intervention / Treatment
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* Procedure: Paravertebral block with methylene blue
* Procedure: Thoracic Epidural Anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paravertebral block with methylene blue<br>With the patient sitting, the patient will receive paravertebral block at T4-T5 level before general anesthesia induction | Procedure: Paravertebral block with methylene blue<br>* 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.<br>|
| Active Comparator: Thoracic Epidural Anesthesia<br>With the patient sitting, the patient will receive thoracic epidural anesthesia at T4-T8 level before general anesthesia induction | Procedure: Thoracic Epidural Anesthesia<br>* 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.<br>|

What is the study measuring?
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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 | 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 | 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 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 | 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 | Total days of hospital stay will be recorded | From hospital admission to discharge, up to 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, regional anesthesia, thoracoscopy