Video-assisted Thoracoscopic Surgery (VATS)r-PVB-1NCT07567950
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Video-assisted Thoracoscopic Pneumonectomy
A study testing Revised-Paravertebral Nerve Block in people with Video-assisted Thoracoscopic Surgery (VATS) and Postoperative Pain, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Video-assisted Thoracoscopic Surgery (VATS), Postoperative Pain, Quality of Recovery
- What is being tested?
- Revised-Paravertebral Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Scheduled for elective video-assisted thoracoscopic pneumonectomy for benign or malignant diseases
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Video-assisted Thoracoscopic Surgery (VATS), Postoperative Pain, Quality of Recovery, Lung Diseases
- Being tested
- Revised-Paravertebral Nerve Block, Control
- Keywords
- Video-Assisted Thoracoscopic Surgery, Postoperative Pain, Quality of Recovery, Paravertebral Nerve Block, intercostal space block
- Medical subject headings
- Pain, Postoperative, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revised-Paravertebral Nerve BlockProcedure or surgery
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.
ControlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Revised-Paravertebral Nerve Block |
| PVB | Other | Control Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Postoperative day 1 and postoperative day 2
Secondary outcomes (6)
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.
Measured: 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.
Measured: Postoperative day 1 and postoperative day 2
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start6 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracoscopic Surgery (VATS)Studies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567950
- Sponsor's protocol ID
- E2026081
- Acronym
- r-PVB-1
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revised-Paravertebral Nerve Blocks for Video-Assisted Thoracoscopic Surgery: A Randomized, Controlled, Observer-masked Noninferiority Trial.
- ClinicalTrials.gov ID
- NCT07567950
- Acronym / sponsor ID
- r-PVB-1 / E2026081
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 6 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| r-PVB | Experimental | Procedure: Revised-Paravertebral Nerve BlockParticipants in this arm will receive Revised-Paravertebral Nerve Block (r-PVB) after induction of general anesthesia and before the start of surgery. |
| PVB | Other | Procedure: ControlControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- Scheduled for elective video-assisted thoracoscopic pneumonectomy for benign or malignant diseases
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revised-Paravertebral Nerve BlockRevised-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. | Procedure or surgery | r-PVB |
| ControlParavertebral 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. | Procedure or surgery | PVB |
Primary outcome
Mean postoperative NRS pain score during the first 2 postoperative days
Time frame: From post-anesthesia care unit through postoperative day 2
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).
Mean QoR-15 score on postoperative days 1 and 2
Time frame: Postoperative day 1 and postoperative day 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.
6 secondary outcomes
Resting and movement NRS pain scores on postoperative days 1 and 2
Time frame: Postoperative day 1 and postoperative day 2
Proportion of participants with pain score 4 or greater
Time frame: Postoperative day 1 and postoperative day 2
Postoperative opioid and analgesic consumption
Time frame: Postoperative day 1 and postoperative day 2
Postoperative complications
Time frame: From surgery through postoperative day 30
Length of postoperative hospital stay
Time frame: From surgery through postoperative day 30
Patient satisfaction with analgesia
Time frame: Postoperative day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Revised-Paravertebral Nerve Block in people with Video-assisted Thoracoscopic Surgery (VATS) and Postoperative Pain, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangcai Ruan, MD (+86 13760710099, ruanxc@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean postoperative NRS pain score during the first 2 postoperative days (time frame: From post-anesthesia care unit through postoperative day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.