Pulmonary NodulePhase 4NCT07512635
Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Quality of Recovery in VATS Partial Pneumonectomy
A Phase 4 study testing Bupivacaine Hydrochloride and Bupivacaine liposome in people with Pulmonary Nodule and Liposomal Bupivacaine, run by Sanming First Hospital at 1 site in China.
Trial summary
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive approach for partial pneumonectomy, but postoperative pain remains a major challenge affecting recovery. Intercostal nerve block (ICNB) with conventional local anesthetics provides limited duration of analgesia, often insufficient to cover the peak… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Nodule, Liposomal Bupivacaine
- What is being tested?
- Bupivacaine Hydrochloride and Bupivacaine liposome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2026to 30 Apr 2027
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for thoracic surgery under general anesthesia via thoracoscopic approach;
- Age 18-65 years;
- Classified as Grade I-II by the American Society of Anesthesiologists (ASA).
Who cannot join
- History of local anesthetic allergy.
- Chronic opioid users.
- Contraindications for nerve block, including infection at the puncture site and coagulation disorders;
- Language communication impairment.
- Other conditions unsuitable for inclusion in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
SanMing First Hospital
Sanming, Fujian
Huifen Lin, PHD, 0591-5183881, 306246774@qq.com
About this study
Official title: Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Postoperative Quality of Recovery in Patients Undergoing Video-assisted Thoracoscopic Partial Pneumonectomy
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive approach for partial pneumonectomy, but postoperative pain remains a major challenge affecting recovery. Intercostal nerve block (ICNB) with conventional local anesthetics provides limited duration of analgesia, often insufficient to cover the peak pain period after surgery. Liposomal bupivacaine is a long-acting formulation designed to provide extended analgesia up to 72 hours. This study aims to evaluate the effect of preoperative ICNB with liposomal bupivacaine compared with conventional bupivacaine hydrochloride on postoperative quality of recovery in patients undergoing VATS partial pneumonectomy. The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively. We hypothesize that liposomal bupivacaine ICNB results in superior recovery quality compared with conventional bupivacaine, with reduced postoperative pain and opioid consumption.
- Conditions
- Pulmonary Nodule, Liposomal Bupivacaine
- Being tested
- Bupivacaine Hydrochloride, Bupivacaine liposome
- Keywords
- Liposomal bupivacaine, Intercostal nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Also called Marcaine, Sensorcaine
Single-dose, pre-procedural intercostal nerve block with bupivacaine hydrochloride, administered by thoracoscopy prior to surgery.
Bupivacaine liposomeDrug
Also called Exparel, liposomal bupivacaine
Single-dose, pre-procedural intercostal nerve block with bupivacaine liposome, administered by thoracoscopy prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 30 mL of 0.25% bupivacaine hydrochloride was administered by the surgeon under thoracoscopy to perform intercostal nerve block at the 3rd to 8th intercostal spaces, with 5 mL injected into each intercostal space prior to the start of the procedure. Receives: Drug: Bupivacaine Hydrochloride |
| Liposome bupivacaine group | Experimental | A 30 mL solution was prepared by diluting 15 mL of bupivacaine liposome with 15 mL of 0.9% sodium chloride. Prior to the procedure, the surgeon performed intercostal nerve blockage at the 3rd to 8th intercostal spaces under thoracoscopy, injecting 5 mL into each intercostal space. Receives: Drug: Bupivacaine liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Quality of Recovery at 24 hours
Quality of Recovery-15 (QoR-15) questionnaire. The scale includes 15 items across 5 domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10 (0 = worst possible recovery; 10 = best possible recovery). Total score ranges from 0 to 150, with higher scores indicating better recovery.
Measured: 24 hours after surgery
Secondary outcomes (8)
Postoperative Quality of Recovery at 48 hours
Quality of Recovery-15 (QoR-15) questionnaire. The scale includes 15 items across 5 domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10 (0 = worst possible recovery; 10 = best possible recovery). Total score ranges from 0 to 150, with higher scores indicating better recovery.
Measured: 48 hours after surgery
Area Under the Curve (AUC) of Pain Scores in the First 48 Hours
Pain intensity assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Assessments are performed at 0, 1, 3, 6, 12, 24, 36, and 48 hours after arrival in the post-anesthesia care unit (PACU), separately for pain at rest and pain during coughing (movement). AUC is calculated using the trapezoidal method.
Measured: From PACU arrival to 48 hours post-PACU arrival (assessed at 8 time points)
Cumulative Morphine Consumption in the First 48 Hours
Total cumulative morphine consumption (in mg) recorded from the patient-controlled analgesia (PCA) device during the first 48 hours after surgery.
Measured: First 48 hours after surgery
Time to First PCA Demand
Time interval from arrival in the post-anesthesia care unit (PACU) to the first demand dose of patient-controlled intravenous analgesia (PCIA).
Measured: Up to 48 hours
Patient Satisfaction
Patient satisfaction with postoperative analgesia assessed using a 5-point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied.
Measured: 48 hours after surgery
Duration of PACU Stay
Time interval from arrival in the post-anesthesia care unit (PACU) until the Aldrete score reaches ≥9.
Measured: From PACU arrival to Aldrete score ≥9, up to 1 hour
Emergence time
Time interval from discontinuation of anesthetic agents until the patient shows a purposeful response to verbal command.
Measured: Up to 1 hour
Intraoperative Remifentanil Consumption
Total intraoperative remifentanil consumption (in μg) from the start of anesthesia maintenance until the end of surgery.
Measured: Intraoperative period (from anesthesia maintenance initiation to end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start6 Apr 2026
- Primary completion7 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NoduleStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanming First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Huifen, Sanming First Hospital
- Investigators
- Huifen Lin, MD, Principal investigator, No. 15, Liedong Street, Sanyuan District, Sanming City, Fujian Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512635
- Sponsor's protocol ID
- Ming-Yi-Yuan-Ethics-2024-54/02
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Postoperative Quality of Recovery in Patients Undergoing Video-assisted Thoracoscopic Partial Pneumonectomy
- ClinicalTrials.gov ID
- NCT07512635
- Acronym / sponsor ID
- Ming-Yi-Yuan-Ethics-2024-54/02
- Conditions
- Pulmonary Nodule, Liposomal Bupivacaine
- Keywords
- Liposomal bupivacaine, Intercostal nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sanming First HospitalUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Apr 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.
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive approach for partial pneumonectomy, but postoperative pain remains a major challenge affecting recovery. Intercostal nerve block (ICNB) with conventional local anesthetics provides limited duration of analgesia, often insufficient to cover the peak pain period after surgery. Liposomal bupivacaine is a long-acting formulation designed to provide extended analgesia up to 72 hours. This study aims to evaluate the effect of preoperative ICNB with liposomal bupivacaine compared with conventional bupivacaine hydrochloride on postoperative quality of recovery in patients undergoing VATS partial pneumonectomy. The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively. We hypothesize that liposomal bupivacaine ICNB results in superior recovery quality compared with conventional bupivacaine, with reduced postoperative pain and opioid consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Bupivacaine Hydrochloride30 mL of 0.25% bupivacaine hydrochloride was administered by the surgeon under thoracoscopy to perform intercostal nerve block at the 3rd to 8th intercostal spaces, with 5 mL injected into each intercostal space prior to the start of the procedure. |
| Liposome bupivacaine group | Experimental | Drug: Bupivacaine liposomeA 30 mL solution was prepared by diluting 15 mL of bupivacaine liposome with 15 mL of 0.9% sodium chloride. Prior to the procedure, the surgeon performed intercostal nerve blockage at the 3rd to 8th intercostal spaces under thoracoscopy, injecting 5 mL into each intercostal space. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for thoracic surgery under general anesthesia via thoracoscopic approach;
- Age 18-65 years;
- Classified as Grade I-II by the American Society of Anesthesiologists (ASA).
Key exclusion criteria (5 listed)
- History of local anesthetic allergy.
- Chronic opioid users.
- Contraindications for nerve block, including infection at the puncture site and coagulation disorders;
- Language communication impairment.
- Other conditions unsuitable for inclusion in the trial.
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 |
|---|---|---|
| Bupivacaine HydrochlorideAlso: Marcaine, SensorcaineSingle-dose, pre-procedural intercostal nerve block with bupivacaine hydrochloride, administered by thoracoscopy prior to surgery. | Drug | Control group |
| Bupivacaine liposomeAlso: Exparel, liposomal bupivacaineSingle-dose, pre-procedural intercostal nerve block with bupivacaine liposome, administered by thoracoscopy prior to surgery. | Drug | Liposome bupivacaine group |
Primary outcome
Postoperative Quality of Recovery at 24 hours
Time frame: 24 hours after surgery
Quality of Recovery-15 (QoR-15) questionnaire. The scale includes 15 items across 5 domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10 (0 = worst possible recovery; 10 = best possible recovery). Total score ranges from 0 to 150, with higher scores indicating better recovery.
8 secondary outcomes
Postoperative Quality of Recovery at 48 hours
Time frame: 48 hours after surgery
Area Under the Curve (AUC) of Pain Scores in the First 48 Hours
Time frame: From PACU arrival to 48 hours post-PACU arrival (assessed at 8 time points)
Cumulative Morphine Consumption in the First 48 Hours
Time frame: First 48 hours after surgery
Time to First PCA Demand
Time frame: Up to 48 hours
Patient Satisfaction
Time frame: 48 hours after surgery
Duration of PACU Stay
Time frame: From PACU arrival to Aldrete score ≥9, up to 1 hour
Emergence time
Time frame: Up to 1 hour
Intraoperative Remifentanil Consumption
Time frame: Intraoperative period (from anesthesia maintenance initiation to end of surgery)
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 18 Jun 2026.
- Individual participant dataSharing planned: Yes. After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.
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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.
Huifen Lin, MD principal investigator
No. 15, Liedong Street, Sanyuan District, Sanming City, Fujian Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Hydrochloride and Bupivacaine liposome in people with Pulmonary Nodule and Liposomal Bupivacaine, run by Sanming First Hospital at 1 site in China.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Huifen Lin, MD (（0598）8803263, smyhb0598@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Quality of Recovery at 24 hours (time frame: 24 hours after surgery). 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 18 Jun 2026.