Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Video-assisted Thoracoscopic Pneumonectomy (r-PVB-1)

Revised-Paravertebral Nerve Blocks for Video-Assisted Thoracoscopic Surgery: A Randomized, Controlled, Observer-masked Noninferiority Trial.

Revised-Paravertebral Nerve Block (r-PVB) is performed right after induction of general anesthesia and before lateral positioning of surgery. Under ultrasound guidance, an intercostal space between the 6th and 8th 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. Traditional Paravertebral Nerve Block (PVB) 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 6th and 8th transverse processes, 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. Administer 2% lidocaine in pulsatile injections, 1-2 ml per pulse, observing the spread of fluid at the needle tip on ultrasound and depression of the pleura. Repeat pulsatile injections until a total of 5 ml lidocaine is administered, and if necessary, increase with another 5 ml of pulsatile lidocaine. The fluid movement and pleura depression observed on ultrasound confirm proper needle placement. Then, use this needle to inject 30 ml of 0.5% ropivacaine to complete the PVB. The surgical procedure will start right after the intervention blocks.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Diseases; Postoperative Pain; Quality of Recovery; Video-assisted Thoracoscopic Surgery (VATS)
• Intervention / Treatment: Procedure: Revised-Paravertebral Nerve Block; Procedure: Control

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangcai Ruan, MD; Phone Number: +86 13760710099; Email: ruanxc@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: r-PVB; 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; 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.
Other: PVB; Control	Procedure: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean postoperative NRS pain score during the first 2 postoperative days	Postoperative pain will be assessed using a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine). 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), ranging from 0 (the worst) to 150 (the best). 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid and analgesic consumption	Postoperative opioid and other analgesic consumption will be recorded and compared between groups. Opioid use will be converted to oral morphine equivalents where appropriate.	Postoperative day 1 and postoperative day 2
Postoperative complications	Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.	From surgery through postoperative day 30
Length of postoperative hospital stay	Length of hospital stay will be defined as the total number of days hospitalized after surgery, including readmission within 30 days if applicable.	From surgery through postoperative day 30
Patient satisfaction with analgesia	Patient satisfaction with postoperative analgesia will be assessed using a 5-point scale ranging from very dissatisfied to very satisfied.	Postoperative day 2
Resting and movement NRS pain scores on postoperative days 1 and 2	Resting and movement-related pain will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), at predefined time points on postoperative days 1 and 2.	Postoperative day 1 and postoperative day 2
Proportion of participants with pain score 4 or greater	The proportion of participants with clinically significant pain, defined as the Numerical Rating Scale (NRS, 0-10) of 4 or greater, will be compared between groups.	Postoperative day 1 and postoperative day 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of local anesthetic systemic toxicity	The incidence of local anesthetic systemic toxicity (LAST) will be recorded and compared between groups.	From intervention through postoperative day 30
Morbidity within 30 days after surgery	Postoperative morbidity within 30 days after surgery will be recorded and compared between groups.	From surgery through postoperative day 30
Readmission within 30 days after surgery	Hospital readmission within 30 days after surgery will be recorded and compared between groups.	From surgery through postoperative day 30
Pain scores at 30 days after surgery	Resting and movement-related pain at 30 days after surgery will be assessed using the Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain the patient can imagine).	Postoperative day 30
QoR-15 score at 30 days after surgery	Quality of recovery at 30 days after surgery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).	Postoperative day 30

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Quality of Recovery; Paravertebral Nerve Block; Video-Assisted Thoracoscopic Surgery; intercostal space block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Lung Diseases
• Other Study ID Numbers: E2026081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No