Local Analgesia Via Nerve BlockPhase 2NCT06529432
A Study of Bupivacaine Liposome Injection in the Treatment of Pain After Thoracoscopic Surgery
A Phase 2 study testing Bupivacaine Liposome Injection and Bupivacaine Hydrochloride Injection in people with Local Analgesia Via Nerve Block, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of bupivacaine liposomes for paravertebral nerve block in the treatment of thoracoscopic postoperative pain, and to evaluate the relevant human pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Local Analgesia Via Nerve Block
- What is being tested?
- Bupivacaine Liposome Injection and Bupivacaine Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2026to Nov 2026
- Phase
- Phase 2
- 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
- Subjects who are willing to strictly follow the clinical trial protocol to complete this study and voluntarily sign informed consent;
- Elective surgical subjects undergoing lobectomy by single-aperture thoracoscope under general anesthesia;
- age ≥18 years old , Male or female;
- 18 kg/m2≤BMI≤30 kg/m2;
- ASA Physical Status Classification I-II;
- Female subjects of childbearing potential must agree to use contraception and refrain from egg donation from the signing of the informed consent form until 30 days after the last dose of the investigational drug. Serum or urine pregnancy tests must be negative before dosing and during the trial, and they must not be lactating. Male subjects with partners of childbearing potential must agree to use contraception and refrain from sperm donation from the signing of the informed consent form until 30 days after the last dose of the investigational drug.
Who cannot join
- Participants with any of the following criteria were excluded from the study：
- Pre-existing and combined diseases:
- Subjects with a history of myocardial infarction or unstable angina pectoris, or a history of severe arrhythmias such as atrioventricular block of degree II and above, or NYHA grade II and above in the 6 months before randomization; (2) Subjects with a history of ischemic stroke or transient ischemic attack (TIA); (3) Subjects with psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction; (4) Subjects with sensory disorders such as hyperalgesia; (5) Subjects with other physical pain witch may affect the evaluation of postoperative pain; (6) Subjects with airway or spinal anatomic factors caused by obstruction of ventilation, bronchiectasis, severe intraoperative thoracic adhesion, etc.
- 2. Laboratory and other tests:
- Abnormal laboratory results during screening.
- •Fasting blood glucose (FPG) ≥10.0mmol/L.
Show all 26Show fewer
- •Abnormal liver function: aspartate aminotransferase (AST) or/and alanine aminotransferase (ALT) and/or total bilirubin (TBIL) ≥1.5×ULN.
- Abnormal renal function: serum creatinine (Cr) ≥1.5×ULN, or dialysis subjects.
- Abnormal coagulation function: PT> upper normal value +3s and/or APTT > upper normal value +10s.
- Platelet (PLT) <80×109/L.
- Hemoglobin concentration (Hb) < 70g/L.
- Screening period heart rate < 50 beats/min or heart rate > 100 beats/min; 12-lead ECG QTc interval prolonged: male ≥450ms, female ≥470ms.
- Subjects with refractory hypertension or a history of refractory hypertension before randomization.
- 3. Combined drugs:
- Subjects who allergic to or contraindicated with bupivacaine, other amide local anesthetics, and other drugs that may be used during the trial (e.g., propofol, remazolam, opioids, etc.).
- Subjects who used any of the following drugs within 5 drug half-lives prior before randomization (drug half-lives are based on actual drug instructions, or at least 48 hours of elution if half-lives are unknown):
- Class III antiarrhythmic drugs such as amiodarone.
- Drugs that affect liver metabolism: strong CYP1A2 inhibitors such as ciprofloxacin, enoxacin, fluvoxamine; CYP1A2 substrates: such as theophylline, imipramine; Strong CYP3A4 inhibitors such as voriconazole, ketoconazole, Ritonavir; CYP3A4 substrates such as darunavir, Indinavir, saquinavir; Strong CYP3A4 inducers such as rifampin.
- Intravenous or oral corticosteroids.
- Sedative drugs: benzodiazepines (such as diazepam, flurazepam, oxazepam, cloazepine, triazolam, alprazolam, esazolam, midazolam, etc.), barbiturates, carbamazepine, phenytoin, magnesium sulfate, chloral hydrate, etc..
- Pain relief and other drugs: Nonsteroidal anti-inflammatory drugs (aspirin is permitted for the prevention of cardiovascular events, provided it is used steadily for at least 30 days prior to randomization, Daily dose ≤100mg/ day), opioid agonists/antagonists, central alpha-adrenergic agonists (e.g. Clonidine, dexmedetomidine), anticonvulsants (e.g. Carbamazepine, pregabalin, gabapentin), antidepressants (e.g. Tricyclic, selective 5-HT reuptake inhibitors).
- 4. Others:
- Subjects had a history of substance abuse, drug use, and/or alcohol abuse within the 1 year prior to randomization, with alcohol abuse defined as drinking an average of more than 2 units of alcohol per day (1 unit =360mL beer or 45mL liquor with 40% alcohol or 150 ml wine); Or consume alcoholic food or drink within 24 hours before receiving the study drug.
- Subjects consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, grapefruit juice, caffeinated beverages (averaging more than 8 cups per day, 200 mL per cup) in the 14 days prior to randomization.
- Subjects who have participated in other clinical trials as subjects, and/or previously received investigational drug or device in this clinical trial within the 3 months prior to randomization.
- Subjects who have any other factors deemed unsuitable for participation in this trial by the investigator.
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
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Changhong Miao, +86-13681975062, miao.changhong@zs-hospital.sh.cn
Changhong Miao
About this study
Official title: Efficacy, Safety and Pharmacokinetics of Bupivacaine Liposome Injection for Paravertebral Nerve Block in the Treatment of Postoperative Pain After Thoracoscopic Surgery: a Multicenter, Randomized, Double-blind, Dose-finding, Positive Control, Phase Ⅱ Clinical Trial
The objective of this study is to evaluate the efficacy, safety, and tolerability of bupivacaine liposomes for paravertebral nerve block in the treatment of thoracoscopic postoperative pain, and to evaluate the relevant human pharmacokinetics.
- Conditions
- Local Analgesia Via Nerve Block
- Being tested
- Bupivacaine Liposome Injection, Bupivacaine Hydrochloride Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Liposome InjectionDrug
Bupivacaine Liposome Injection Low Dose or Moderate Dose or High Dose
Bupivacaine Hydrochloride InjectionDrug
Bupivacaine Hydrochloride Injection Low Dose or Moderate Dose or High Dose
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Liposome Injection | Experimental | Not described Receives: Drug: Bupivacaine Liposome Injection |
| Bupivacaine Hydrochloride Injection | Active comparator | Not described Receives: Drug: Bupivacaine Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the time curve of pain intensity during exercise (or cough) for 72 hours after administration
Measured: 0 minute to 72 hours after administration
Secondary outcomes (12)
Area under the curve of pain intensity and time in exercise (or cough) state in 0-12h, 12-24h, 12-48h and 12-72h after administration
Measured: 0 minute to 72 hours after administration
Area under the curve of pain intensity and time in resting state in 0-12h, 12-24h, 12-48h, 12-72h and 0-72h after administration
Measured: 0 minute to 72 hours after administration
Pain intensity scores in resting state and exercise (or cough) state, including within 30 minutes after anesthesia recovery and various time points after administration (6h, 8h, 12h, 18h, 24h, 30h, 36h, 48h, 72h)
Measured: recovery from anesthesia to 72 hours after administration
The duration of the first pain intensity score ≥4 points during exercise (or cough) after anesthesia recovery
Measured: 0 minute to 72 hours after administration
The duration of the first pain intensity score ≥4 points at rest after anesthesia recovery
Measured: 0 minute to 72 hours after administration
Maximum pain intensity score during exercise (or cough) within 72 hours after administration
Measured: 0 minute to 72 hours after administration
Percentage of painless (pain intensity score ≤1 at rest) subjects at planned time points
Measured: 0 minute to 72 hours after administration
Proportion of subjects who did not use remedial analgesia in 0-12h, 12-24h, 24-48h, 48-72h, 0-72h
Measured: 0 minute to 72 hours after administration
Cumulative use of remedial analgesics in 0-12h, 12-24h, 24-48h, 48-72h, 0-72h
Measured: 0 minute to 72 hours after administration
Time of first use of remedial analgesics
The first time additional analgesic medication is required due to insufficient analgesic efficacy.
Measured: The time of the first pain intensity rating to 72 hours after administration
Subjects' analgesic satisfaction scores
Measured: 72 hours after administration
Investigators' analgesic satisfaction scores
Measured: 72 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start3 Mar 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Analgesia Via Nerve BlockStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized, double-blind, dose-finding, positive control, phase Ⅱ clinical trial of liposomal bupivacaine injection
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529432
- Sponsor's protocol ID
- BULI-201
- Status last verified
- Mar 2026
- First submitted
- 26 Jul 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Pharmacokinetics of Bupivacaine Liposome Injection for Paravertebral Nerve Block in the Treatment of Postoperative Pain After Thoracoscopic Surgery: a Multicenter, Randomized, Double-blind, Dose-finding, Positive Control, Phase Ⅱ Clinical Trial
- ClinicalTrials.gov ID
- NCT06529432
- Acronym / sponsor ID
- BULI-201
- Conditions
- Local Analgesia Via Nerve Block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 31 Jul 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 objective of this study is to evaluate the efficacy, safety, and tolerability of bupivacaine liposomes for paravertebral nerve block in the treatment of thoracoscopic postoperative pain, and to evaluate the relevant human pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A multicenter, randomized, double-blind, dose-finding, positive control, phase Ⅱ clinical trial of liposomal bupivacaine injection
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Liposome Injection | Experimental | Drug: Bupivacaine Liposome Injection |
| Bupivacaine Hydrochloride Injection | Active comparator | Drug: Bupivacaine Hydrochloride Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who are willing to strictly follow the clinical trial protocol to complete this study and voluntarily sign informed consent;
- Elective surgical subjects undergoing lobectomy by single-aperture thoracoscope under general anesthesia;
- age ≥18 years old , Male or female;
- 18 kg/m2≤BMI≤30 kg/m2;
- ASA Physical Status Classification I-II;
Key exclusion criteria (26 listed)
- Participants with any of the following criteria were excluded from the study：
- Pre-existing and combined diseases:
- Subjects with a history of myocardial infarction or unstable angina pectoris, or a history of severe arrhythmias such as atrioventricular block of degree II and above, or NYHA grade II and above in the 6 months before randomization; (2) Subjects with a history of ischemic stroke or transient ischemic attack (TIA); (3) Subjects with psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction; (4) Subjects with sensory disorders such as hyperalgesia; (5) Subjects with other physical pain witch may affect the evaluation of postoperative pain; (6) Subjects with airway or spinal anatomic factors caused by obstruction of ventilation, bronchiectasis, severe intraoperative thoracic adhesion, etc.
- Abnormal laboratory results during screening.
- •Fasting blood glucose (FPG) ≥10.0mmol/L.
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 Liposome InjectionBupivacaine Liposome Injection Low Dose or Moderate Dose or High Dose | Drug | Bupivacaine Liposome Injection |
| Bupivacaine Hydrochloride InjectionBupivacaine Hydrochloride Injection Low Dose or Moderate Dose or High Dose | Drug | Bupivacaine Hydrochloride Injection |
Primary outcome
Area under the time curve of pain intensity during exercise (or cough) for 72 hours after administration
Time frame: 0 minute to 72 hours after administration
12 secondary outcomes
Area under the curve of pain intensity and time in exercise (or cough) state in 0-12h, 12-24h, 12-48h and 12-72h after administration
Time frame: 0 minute to 72 hours after administration
Area under the curve of pain intensity and time in resting state in 0-12h, 12-24h, 12-48h, 12-72h and 0-72h after administration
Time frame: 0 minute to 72 hours after administration
Pain intensity scores in resting state and exercise (or cough) state, including within 30 minutes after anesthesia recovery and various time points after administration (6h, 8h, 12h, 18h, 24h, 30h, 36h, 48h, 72h)
Time frame: recovery from anesthesia to 72 hours after administration
The duration of the first pain intensity score ≥4 points during exercise (or cough) after anesthesia recovery
Time frame: 0 minute to 72 hours after administration
The duration of the first pain intensity score ≥4 points at rest after anesthesia recovery
Time frame: 0 minute to 72 hours after administration
Maximum pain intensity score during exercise (or cough) within 72 hours after administration
Time frame: 0 minute to 72 hours after administration
Percentage of painless (pain intensity score ≤1 at rest) subjects at planned time points
Time frame: 0 minute to 72 hours after administration
Proportion of subjects who did not use remedial analgesia in 0-12h, 12-24h, 24-48h, 48-72h, 0-72h
Time frame: 0 minute to 72 hours after administration
Cumulative use of remedial analgesics in 0-12h, 12-24h, 24-48h, 48-72h, 0-72h
Time frame: 0 minute to 72 hours after administration
Time of first use of remedial analgesics
Time frame: The time of the first pain intensity rating to 72 hours after administration
Subjects' analgesic satisfaction scores
Time frame: 72 hours after administration
Investigators' analgesic satisfaction scores
Time frame: 72 hours after administration
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 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Local Analgesia Via Nerve Block
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruiting
Combination Versus Alone Liposomal Bupivacaine Blocks in Minimally Invasive Thoracic Surgery-1
Lung Cancer (Diagnosis)
Not yet recruiting
Artificial Intelligence vs. Automated Messaging for Continuous Regional Analgesia Follow-up
Anesthesia, Anesthesia , Analgesia
Not yet recruiting
Comparison of Paravertebral Block and Deep Parasternal Intercostal Plane Block in Cardiac Surgery
Postoperative Pain, Cardiac Surgery
Recruiting
PENG Block: Continuous Infusion vs. Programmed Intermittent Bolus in Neck of Femur Fracture
Hip Fracture, Analgesia Post Fracture
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine Liposome Injection and Bupivacaine Hydrochloride Injection in people with Local Analgesia Via Nerve Block, run by Jiangsu HengRui Medicine Co., Ltd. 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 6 inclusion and 26 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 12 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Thea Yu (+86-0518-82342973, suyang.yu.sy17@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the time curve of pain intensity during exercise (or cough) for 72 hours after administration (time frame: 0 minute to 72 hours after administration). 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 12 Mar 2026.