Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Video-assisted Thoracoscopic Pneumonectomy: A Randomized Clinical Trial

NCT07567950 | Not Yet Recruiting

• 1 other identifier: E2026081
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

After video-assisted thoracoscopic pneumonectomy, pain remains an important problem affecting patient recovery. We developed a revised paravertebral block (r-PVB) as a single-shot, large-volume intercostal-space injection performed at the exposed mid-axillary eighth or ninth intercostal level with the patient kept supine after induction of anesthesia. Unlike conventional paravertebral block, the revised paravertebral block (r-PVB) does not require the patient to take a specific prone or lateral position or puncture the classical paravertebral target near the transverse process. Instead, it exploits the characteristic of local anesthetic spreading medially along the intercostal-endothoracic-extrapleural continuum, thereby achieving a functional paravertebral block while avoiding direct entry into the paravertebral space and the need for specific body positioning. This revised design addresses several practical limitations of conventional paravertebral block (PVB): it eliminates the need to reposition an anesthetized patient, uses a more accessible and potentially clearer sonographic window, reduces interference from transverse-process shadowing, and facilitates in-plane needle visualization.

Conditions

Video-assisted Thoracoscopic Surgery (VATS); Postoperative Pain; Quality of Recovery; Lung Diseases

Keywords

Video-Assisted Thoracoscopic Surgery; Postoperative Pain; Quality of Recovery; Paravertebral Nerve Block; intercostal space block

Outcome Measures

Primary Outcomes (2)

• Mean postoperative NRS pain score during the first 2 postoperative days

  Postoperative pain will be assessed using the Numerical Rating Scale (NRS, 0-10). The primary pain outcome is the mean of 8 postoperative NRS pain scores collected in the post-anesthesia care unit, on the evening of surgery, and on postoperative days 1 and 2 (morning, midday, and evening).

  From post-anesthesia care unit through postoperative day 2

• Mean QoR-15 score on postoperative days 1 and 2

  Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15; range 0-150). The primary recovery outcome is the mean QoR-15 score measured on postoperative day 1 and postoperative day 2.

  Postoperative day 1 and postoperative day 2

Secondary Outcomes (6)

• Resting and movement NRS pain scores on postoperative days 1 and 2

  Postoperative day 1 and postoperative day 2

• Proportion of participants with NRS pain score 4 or greater

  Postoperative day 1 and postoperative day 2

• Postoperative opioid and analgesic consumption

  Postoperative day 1 and postoperative day 2

• Postoperative complications

  From surgery through postoperative day 30

• Length of postoperative hospital stay

  From surgery through postoperative day 30

Other Outcomes (5)

• Incidence of local anesthetic systemic toxicity

  From intervention through postoperative day 30

• NRS pain scores at 30 days after surgery

  Postoperative day 30

• QoR-15 score at 30 days after surgery

  Postoperative day 30

Study Arms (2)

r-PVB

EXPERIMENTAL

Participants in this arm will receive Revised-Paravertebral Nerve Block (r-PVB) after induction of general anesthesia and before the start of surgery.

Procedure: Revised-Paravertebral Nerve Block

PVB

OTHER

Control

Procedure: Control

Interventions

Revised-Paravertebral Nerve Block PROCEDURE

Revised-Paravertebral Nerve Block (r-PVB) is performed after induction of general anesthesia and before the start of surgery. Under ultrasound guidance, an intercostal space between the 7th and 9th ribs at the midaxillary line is identified. Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.

r-PVB

Control PROCEDURE

Paravertebral Nerve Block (PVB), the control of investigated intervention, is performed right after the lateral positioning of surgery under ultrasound guidance. According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches. Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the transverse process, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space. Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement. Stop advancing the needle when the tip passes through the superior costotransverse ligament.

PVB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Scheduled for elective video-assisted thoracoscopic pneumonectomy for benign or malignant diseases

You may not qualify if:

• Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis, or allergy to local anesthetics
• Surgeon-estimated high likelihood of conversion to open surgery
• Chronic opioid use
• Heart failure, liver failure, or renal failure
• Coagulation disorders
• History of allergy to local anesthetics
• Inability to comply with the study protocol, including severe psychiatric illness, refusal to provide informed consent, or anticipated difficulty with postoperative follow-up

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

MeSH Terms

Conditions

Pain, Postoperative; Lung Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiangcai Ruan, MD

CONTACT

+86 13760710099; ruanxc@mail.sysu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share