NCT05812521

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Post Operative Pain
• Thoracic Cancer

Interventions

Type	Name	Description
PROCEDURE	Paravertebral block with methylene blue	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.
PROCEDURE	Thoracic Epidural Anesthesia	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.

Timeline

• Start date: 2020-01-15
• Primary completion: 2022-11-20
• Completion: 2022-12-16
• First posted: 2023-04-13
• Last updated: 2023-04-13

Locations

1 site across 1 country: Italy