Acute PainPhase 4NCT06569953
Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine Hydrochloride in people with Acute Pain and Chronic Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of liposomal Bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Chronic Pain, Postoperative Pain
- What is being tested?
- Liposomal bupivacaine and Bupivacaine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2024to 31 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who scheduled for elective video-assisted thoracoscopic lobectomy under general anesthesia.
- Participants were 18 years or older.
- 18 kg/m2≤BMI≤30 kg/m2
- Participants with American Society of Anesthesiology (ASA) physical status I-III.
- Understand the significance, possible benefits, potential risks of the trial in detail.Understand the procedures and methods of this study.Willing to complete the trial in strict compliance with the clinical trial protocol.Sign the informed consent form voluntarily.
Who cannot join
- with severe cardiovascular and cerebrovascular diseases such as myocardial infarction,unstable angina pectoris,severe cardiac rhythm disorders (second- and third-degree heart block,etc.), New York Heart Association (NYHA) functional class III/IV,Ischemic stroke.
- with psychiatric disorders (such as schizophrenia,depression,etc.) and cognitive impairment.
- with sensory disorders such as hyperalgesia.
- with other bodily pain.
- allergy to amide-type local anesthetics or any of the trial drugs
- taking drugs that affect liver metabolism,corticosteroids,benzodiazepines,non-steroidal anti-inflammatory drugs(NSAIDs),opioid agonist-antagonist,central-alpha 2-agonists,anticonvulsants,antidepressants within 72h.
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- with a history of alcohol or opioid abuse.
- who were pregnant or lactating.
- who were currently included in another clinical study within 3 months.
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
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 4000000
He Huang, ph.D, 0086-13708385559, huanghe@cqmu.edu.cn
About this study
The goal of this clinical trial is to evaluate the efficacy and safety of liposomal Bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy.
Read the detailed description
Researchers will compare liposomal bupivacaine to bupivacaine to see if liposomal bupivacaine works better to treat acute and chronic pain after video-assisted thoracoscopic lobectomy.Participants will:1.Received liposomal bupivacaine or bupivacaine paravertebral block before surgery. 2.Keep a diary of their pain scores within 30min after recovery from anesthesia and 6h, 12h, 24h, 48h, 72h and 90d after the beginning of injection of experimental drugs.
- Conditions
- Acute Pain, Chronic Pain, Postoperative Pain
- Being tested
- Liposomal bupivacaine, Bupivacaine Hydrochloride
- Medical subject headings
- Acute Pain, Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Participants randomized to the intervention arm received 266 mg of liposomal bupivacaine for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline).
Bupivacaine HydrochlorideDrug
Participants randomized to the intervention arm received 0.5% 100 mg of bupivacaine hydrochloride for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline)
| Study group | Role | What they receive |
|---|---|---|
| intervention (liposomal bupivacaine） | Experimental | Participants randomized to the intervention arm received liposomal bupivacaine for paravertebral block before surgery. Receives: Drug: Liposomal bupivacaine |
| control (bupivacaine hydrochloride) | Active comparator | Participants randomized to the intervention arm received bupivacaine hydrochloride for paravertebral block before surgery. Receives: Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the movement-evoked pain intensity-time curve
Area under the pain intensity-time curve in the movement (or coughing) state within 72h after the intervention.
Measured: from 0-72 hours after the intervention
The incidence of chronic postoperative pain
The incidence of chronic postoperative pain at 90 days
Measured: postoperative day (POD) 90
Secondary outcomes (10)
Area under the rest pain intensity-time curve
Area under the pain intensity-time curve at rest within 72h after the intervention.
Measured: from 0-72 hours after the intervention
Movement-evoked pain score
Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score at 30minutes after recovery from anesthesia and at 6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)
Measured: 30 minutes after recovery from anesthesia,6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention
Pain score at rest
Use pain Numeric Rating Scale(NRS) to evaluate the pain score at rest at 30minutes after recovery from anesthesia and at 6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)
Measured: 30 minutes after recovery from anesthesia,6 hours,12hours, 24hours , 48hours and 72 hours after the intervention
Proportion of participants who did not use rescue analgesia
Proportion of participants who did not use rescue analgesia during 0-12 hours, 12-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after the intervention.
Measured: from 0-72 hours after the intervention
The cumulative dosage of rescue analgesia
The cumulative dosage of rescue analgesia during 0-12 hours, 12-24 hours, 24-48 hours, 48-72hours and 0-72hours after the intervention.
Measured: from 0-72 hours after the intervention
The time of first use of rescue analgesia
The time of first use of rescue analgesia
Measured: from 0-72 hours after the intervention
First time out-of-bed
Time of participant's first out-of-bed activity after surgery
Measured: From date of surgery until the date of first out-of-bed，assessed up to 7 days
Length of hospital stay
Duration of participants from hospital admission to hospital discharge
Measured: From date of surgery until the date of first hospital discharge，assessed up to 1 months
Chronic pain score
Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score and rest pain score at 90 days after surgery.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)
Measured: postoperative day (POD) 90
Score of satisfaction with analgesia
At 72 hours after the intervention,the participants rated the satisfaction with analgesia.Satisfaction rating scale 0-5,where 0 was poor drug effectiveness, and 5 was excellent drug efficacy)
Measured: At 72 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start26 Aug 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization was performed in a 1:1 ratio with the use of block randomization.SAS software (version 9.4 or higher) was used to generate the random number and the treatment group to which the random number was assigned.Assignment of Randomization Numbers Using the Interactive Web Response System (IWRS).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Chongqing, LanZhou University, Xiangya Hospital of Central South University, Shapingba District People's Hospital of Chongqing
- Responsible party
- Sponsor
- Investigators
- He Huang, ph.D, Study chair, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569953
- Sponsor's protocol ID
- LBPB
- Status last verified
- Jun 2025
- First submitted
- 13 Aug 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06569953
- Acronym / sponsor ID
- LBPB
- Conditions
- Acute Pain, Chronic Pain, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- People's Hospital of Chongqing, LanZhou University, Xiangya Hospital of Central South University, Shapingba District People's Hospital of Chongqing
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 26 Aug 2024 (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.
The goal of this clinical trial is to evaluate the efficacy and safety of liposomal Bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy.
Detailed description
Researchers will compare liposomal bupivacaine to bupivacaine to see if liposomal bupivacaine works better to treat acute and chronic pain after video-assisted thoracoscopic lobectomy.Participants will:1.Received liposomal bupivacaine or bupivacaine paravertebral block before surgery. 2.Keep a diary of their pain scores within 30min after recovery from anesthesia and 6h, 12h, 24h, 48h, 72h and 90d after the beginning of injection of experimental drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization was performed in a 1:1 ratio with the use of block randomization.SAS software (version 9.4 or higher) was used to generate the random number and the treatment group to which the random number was assigned.Assignment of Randomization Numbers Using the Interactive Web Response System (IWRS).
| Arm | Type | Receives |
|---|---|---|
| intervention (liposomal bupivacaine） | Experimental | Drug: Liposomal bupivacaineParticipants randomized to the intervention arm received liposomal bupivacaine for paravertebral block before surgery. |
| control (bupivacaine hydrochloride) | Active comparator | Drug: Bupivacaine HydrochlorideParticipants randomized to the intervention arm received bupivacaine hydrochloride for paravertebral block before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who scheduled for elective video-assisted thoracoscopic lobectomy under general anesthesia.
- Participants were 18 years or older.
- 18 kg/m2≤BMI≤30 kg/m2
- Participants with American Society of Anesthesiology (ASA) physical status I-III.
- Understand the significance, possible benefits, potential risks of the trial in detail.Understand the procedures and methods of this study.Willing to complete the trial in strict compliance with the clinical trial protocol.Sign the informed consent form voluntarily.
Key exclusion criteria (9 listed)
- with severe cardiovascular and cerebrovascular diseases such as myocardial infarction,unstable angina pectoris,severe cardiac rhythm disorders (second- and third-degree heart block,etc.), New York Heart Association (NYHA) functional class III/IV,Ischemic stroke.
- with psychiatric disorders (such as schizophrenia,depression,etc.) and cognitive impairment.
- with sensory disorders such as hyperalgesia.
- with other bodily pain.
- allergy to amide-type local anesthetics or any of the trial drugs
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 |
|---|---|---|
| Liposomal bupivacaineParticipants randomized to the intervention arm received 266 mg of liposomal bupivacaine for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline). | Drug | intervention (liposomal bupivacaine） |
| Bupivacaine HydrochlorideParticipants randomized to the intervention arm received 0.5% 100 mg of bupivacaine hydrochloride for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline) | Drug | control (bupivacaine hydrochloride) |
Primary outcome
Area under the movement-evoked pain intensity-time curve
Time frame: from 0-72 hours after the intervention
Area under the pain intensity-time curve in the movement (or coughing) state within 72h after the intervention.
The incidence of chronic postoperative pain
Time frame: postoperative day (POD) 90
The incidence of chronic postoperative pain at 90 days
10 secondary outcomes
Area under the rest pain intensity-time curve
Time frame: from 0-72 hours after the intervention
Movement-evoked pain score
Time frame: 30 minutes after recovery from anesthesia,6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention
Pain score at rest
Time frame: 30 minutes after recovery from anesthesia,6 hours,12hours, 24hours , 48hours and 72 hours after the intervention
Proportion of participants who did not use rescue analgesia
Time frame: from 0-72 hours after the intervention
The cumulative dosage of rescue analgesia
Time frame: from 0-72 hours after the intervention
The time of first use of rescue analgesia
Time frame: from 0-72 hours after the intervention
First time out-of-bed
Time frame: From date of surgery until the date of first out-of-bed，assessed up to 7 days
Length of hospital stay
Time frame: From date of surgery until the date of first hospital discharge，assessed up to 1 months
Chronic pain score
Time frame: postoperative day (POD) 90
Score of satisfaction with analgesia
Time frame: At 72 hours after the intervention
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 27 Jun 2025.
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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.
He Huang, ph.D study chair
The Second Affiliated Hospital of Chongqing Medical University
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 Liposomal bupivacaine and Bupivacaine Hydrochloride in people with Acute Pain and Chronic Pain, run by The Second Affiliated Hospital of Chongqing Medical University 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 5 inclusion and 9 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 27 Jun 2025. 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 He Huang, ph.D (86+13708385559, huanghe@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the movement-evoked pain intensity-time curve (time frame: from 0-72 hours after the intervention). 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 27 Jun 2025.