Efficacy of Thoracic Paravertebral Block With Methylene Blue Visual Confirmation in the Management of Postoperative Pain After Video-assisted Thoracoscopic Lobectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Change From Baseline in Pain Scores on the Postoperative Numeric Rating Scale in the first 48 hours postoperatively
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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)
Investigators
Alfonso Fiorelli
Full Professor
University of Campania "Luigi Vanvitelli"