Skip to content

Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Video-assisted Thoracoscopic Pneumonectomy

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07567950
Acronym
r-PVB-1
Enrollment
200
Registered
2026-05-05
Start date
2026-05-06
Completion date
2027-12-31
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief summary

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.

Interventions

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.

PROCEDUREControl

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.

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean postoperative NRS pain score during the first 2 postoperative daysFrom post-anesthesia care unit through postoperative day 2Postoperative 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).
Mean QoR-15 score on postoperative days 1 and 2Postoperative day 1 and postoperative day 2Quality 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.

Secondary

MeasureTime frameDescription
Resting and movement NRS pain scores on postoperative days 1 and 2Postoperative day 1 and postoperative day 2Resting 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.
Proportion of participants with pain score 4 or greaterPostoperative day 1 and postoperative day 2The 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 opioid and analgesic consumptionPostoperative day 1 and postoperative day 2Postoperative opioid and other analgesic consumption will be recorded and compared between groups. Opioid use will be converted to oral morphine equivalents where appropriate.
Postoperative complicationsFrom surgery through postoperative day 30Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.
Length of postoperative hospital stayFrom surgery through postoperative day 30Length of hospital stay will be defined as the total number of days hospitalized after surgery, including readmission within 30 days if applicable.
Patient satisfaction with analgesiaPostoperative day 2Patient satisfaction with postoperative analgesia will be assessed using a 5-point scale ranging from very dissatisfied to very satisfied.

Contacts

CONTACTXiangcai Ruan, MD
ruanxc@mail.sysu.edu.cn+86 13760710099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026