Thoracic Paravertebral BlockPhase 4NCT06165991
Liposomal and Standard Bupivacaine in Thoracic Paravertebral Block for Post-Thoracoscopic Pain
A Phase 4 study testing GroupB:Liposomal bupivacaine and bupivacaine hydrochloride; and Group A: bupivacaine hydrochloride; in people with Thoracic Paravertebral Block and Postoperative Analgesia, run by Yongtao Sun at 1 site in China.
Trial summary
I. Research purpose 1.1 Main Objective: To investigate the efficacy and safety of bupivacaine liposome thoracic paravertebral nerve block for postoperative analgesia after thoracoscopic lobectomy 1.2 Exploratory Objective: To investigate the noninferiority of bupivacaine liposomes in thoracic paravertebral nerve block… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Paravertebral Block, Postoperative Analgesia, Thoracoscopic Lobectomy
- What is being tested?
- GroupB:Liposomal bupivacaine and bupivacaine hydrochloride; and Group A: bupivacaine hydrochloride;
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Jan 2026
- 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
- 1) Age ≥18 years old;
- 2) Patients undergoing unilateral initial thoracoscopic lobectomy under general anesthesia (TV or robot-assisted);
- 3) American Society of Anesthesiologists (ASA) Grade I - III;
- 4) Voluntarily participate in the study and sign the informed consent.
Who cannot join
- 1) Pregnant or lactating women;
- 2) Pulmonary wedge-shaped resection;
- 3) ≥2 thoracic drainage tubes;
- 4) Abnormal liver function: ALT and/or AST>2×ULN, or
- TBIL≥1.5×ULN;
- 5) Renal function impairment (serum creatinine >176μmol/L), or received dialysis treatment within 28 days before surgery;
Show all 11Show fewer
- 6) Participate in another research trial involving an investigational drug within 6 months;
- 7) A history of drug or alcohol abuse;
- 8) Long-term use of opioids (more than 3 months or more than 5 mg daily morphine equivalent per day for 1 month);
- 9) History of allergy to local anesthetics or one of the investigational drugs;
- 10) Uncontrolled mental or neurological symptoms.
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
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250014
yong T Sun, PH.D, 18660795201, sunyongtao1979@163.com
yong T Sun, 18660795201, sunyongtao1979@163.com
About this study
Official title: The Effect of Bupivacaine Liposome Combined With Bupivacaine Hydrochloride on Thoracic Paravertebral Nerve Block for Postoperative Pain After Thoracoscopic Lung Surgery
- Research purpose
1.1 Main Objective: To investigate the efficacy and safety of bupivacaine liposome thoracic paravertebral nerve block for postoperative analgesia after thoracoscopic lobectomy
1.2 Exploratory Objective: To investigate the noninferiority of bupivacaine liposomes in thoracic paravertebral nerve block with standard bupivacaine
Read the detailed description
Standard monitoring, including electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP), pulse oxygen saturation (SpO2), end-tidal carbon dioxide (ETCo2), and bispectral index (BIS) was initiated on arrival in the operating room. A neuromuscular monitor (JS-100, Beijing SLGO Medical Technology Co., Ltd., China) was used to confirm neuromuscular block (NMB).
Intravenous anesthesia was induced with 0.04 mg/kg midazolam, 0.3-0.5 μg/kg sufentanil, 1.5-2.5 mg/kg propofol, and 0.6 mg/kg rocuronium. Hemodynamics were supported with vasoactive agents (atropine, norepinephrine, dopamine, esmolol) as needed. After the train of four count (TOFC) ratio reached zero, a double-lumen tube or a single-lumen tube with a bronchial blocker was inserted, with correct positioning confirmed by fiberoptic bronchoscopy. Under real-time ultrasound visualization, a senior anesthesiologist performed thoracic paravertebral blocks at the T4-5, T6-7, and T8-9 levels in patients placed in the lateral decubitus position, injecting 6 mL, 8 mL, and 6 mL of local anesthetic at the respective levels.
Group B : Patients in the intervention group received a mixture of 10 mL of 1.33% liposomal bupivacaine (133 mg) and 10 mL of 0.5% bupivacaine hydrochloride,.
Group A: whereas those in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg).
All patients received total intravenous anesthesia during surgery. Propofol was administered at a rate of 2-4 mg/kg/h, and remifentanil was administered at a rate of 0.05-0.3 μg/kg/min to maintain a BIS value range from 40 to 60. Rocuronium will be administered and adjusted to achieve deep NMB (defined as a TOFC=0 and a post-tetanic count =1-2). Standard ventilation parameters included a respiratory rate of 10-12 breaths·min-¹ and a positive end-expiratory pressure (PEEP) of 5cmH₂O. During double-lung ventilation, a tidal volume of 8 mL/kg was used, with ETCo2 maintained between 35-45 mmHg and peak airway pressure kept below 20cmH₂O. During single-lung ventilation, the tidal volume was reduced to 6 mL/kg, with ETCo2 maintained below 60 mmHg and peak airway pressure kept below 30cmH₂O. Intravenous sufentanil (0.15 μg/kg) and ondansetron hydrochloride (8mg) were administered prior to the end of surgery. After surgery, patients were transferred to the post-anesthesia care unit (PACU) for further monitoring. Additionally, 2-4 mg/kg of sugammadex was given to reverse the residual effect of rocuronium.
In the PACU, an intravenous bolus of 0.1 μg/kg sufentanil was administered when the numeric rating scale (NRS; 0, no pain; 1-3, mild pain; 4-6, moderate pain; and 7-10, severe pain) score was ≥4. The drugs used for postoperative patient-controlled intravenous analgesia (PCIA) were sufentanil (2 μg/kg), which were diluted in 0.9% normal saline to a final volume of 100mL. The analgesia pump settings were as follows: background dose, 0 mL/h; self-controlled additional dose, 1 mL/time; and lockout time, 10 min. The patients were sent to the ward upon meeting the following criteria for at least 30 minutes: NRS score <4, an Adrelete score ≥9 and absence of other adverse reactions. The number of PCA attempts and the total drug delivery were automatically recorded by the postoperative analgesia system.
- Being tested
- GroupB:Liposomal bupivacaine and bupivacaine hydrochloride;, Group A: bupivacaine hydrochloride;
- Keywords
- liposomal bupivacaine(LB), Thoracic paravertebral nerve block, Postoperative analgesia, thoracoscopic lobectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GroupB:Liposomal bupivacaine and bupivacaine hydrochloride;Drug
Group B::Patients in the intervention group received a mixture of 10 mL of 1.33% liposomal bupivacaine (133 mg) and 10 mL of 0.5% bupivacaine hydrochloride.
Group A: bupivacaine hydrochloride;Drug
Group A:Patients in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg).
| Study group | Role | What they receive |
|---|---|---|
| Group A: bupivacaine hydrochloride | Active comparator | Group A: Patients in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg). Receives: Drug: Group A: bupivacaine hydrochloride; |
| Group B: liposomal bupivacaine and bupivacaine hydrochloride | Experimental | Patients in the intervention group received a mixture of 10 mL of 1.33% liposomal bupivacaine (133 mg) and 10 mL of 0.5% bupivacaine hydrochloride. Receives: Drug: GroupB:Liposomal bupivacaine and bupivacaine hydrochloride; |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the NRS score curve (AUC) for resting
area under the NRS score curve (AUC) for resting and active 48 hours after surgery
Measured: 48hours postoperative
Secondary outcomes (5)
15 quality of recovery assessments (QoR15)
15 quality of recovery assessments (QoR15) at 24, 48, and 72 hours after surgery. Its scores range from 0 to 150, with higher scores indicating better recovery.Based on the scores, QoR can be classified into excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121), and poor (QoR-15 <90).
Measured: at 24, 48, and 72 hours after surgery
area under the NRS score curve (AUC) for exercise
area under the NRS score curve (AUC) for resting and exercise 48 hours after surgery
Measured: 48 hours after surgery
area under the NRS score curve (AUC) for resting and exercise
area under the NRS score curve (AUC) for exercise 72 hours after surgery
Measured: 72 hours after surgery
area under the NRS score curve (AUC) for resting and exercise
area under the NRS score curve (AUC) for resting and exercise 96 hours after surgery
Measured: 96 hours after surgery
cumulative opioid consumption (morphine milligram equivalent, MME
cumulative opioid consumption at 72 hours after surgery (morphine milligram equivalent, MME
Measured: at 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jun 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Paravertebral BlockStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongtao Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongtao Sun, Qianfoshan Hospital
- Investigators
- Sun Y tao, PH.D, Study chair, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165991
- Sponsor's protocol ID
- liposomal bupivacaine LB
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2023
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun Y, Guo N, Fang T, Feng Y, Liu P, Sun D, Li Y, Liu K, Ren Y, Li M, Liu Q, Yang X, Chi Y, Liu Z, Yuan L, Lang B, Yang Z, Feng N, You P, Zhang W, Su D, Wu J. Effect of preoperative thoracic paravertebral block using liposomal bupivacaine combined with drainage-tube patient-controlled analgesia on postoperative pain after thoracoscopic lobectomy: a prospective, multicentre, double-blind, randomized controlled study protocol. Perioper Med (Lond). 2025 Nov 6;14(1):122. doi: 10.1186/s13741-025-00564-2.
PubMed 41199334
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bupivacaine Liposome Combined With Bupivacaine Hydrochloride on Thoracic Paravertebral Nerve Block for Postoperative Pain After Thoracoscopic Lung Surgery
- ClinicalTrials.gov ID
- NCT06165991
- Acronym / sponsor ID
- liposomal bupivacaine LB
- Keywords
- liposomal bupivacaine(LB), Thoracic paravertebral nerve block, Postoperative analgesia, thoracoscopic lobectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- Yongtao SunUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 12 Dec 2023 (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.
- Research purpose
1.1 Main Objective: To investigate the efficacy and safety of bupivacaine liposome thoracic paravertebral nerve block for postoperative analgesia after thoracoscopic lobectomy
1.2 Exploratory Objective: To investigate the noninferiority of bupivacaine liposomes in thoracic paravertebral nerve block with standard bupivacaine
Detailed description
Standard monitoring, including electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP), pulse oxygen saturation (SpO2), end-tidal carbon dioxide (ETCo2), and bispectral index (BIS) was initiated on arrival in the operating room. A neuromuscular monitor (JS-100, Beijing SLGO Medical Technology Co., Ltd., China) was used to confirm neuromuscular block (NMB).
Intravenous anesthesia was induced with 0.04 mg/kg midazolam, 0.3-0.5 μg/kg sufentanil, 1.5-2.5 mg/kg propofol, and 0.6 mg/kg rocuronium. Hemodynamics were supported with vasoactive agents (atropine, norepinephrine, dopamine, esmolol) as needed. After the train of four count (TOFC) ratio reached zero, a double-lumen tube or a single-lumen tube with a bronchial blocker was inserted, with correct positioning confirmed by fiberoptic bronchoscopy. Under real-time ultrasound visualization, a senior anesthesiologist performed thoracic paravertebral blocks at the T4-5, T6-7, and T8-9 levels in patients placed in the lateral decubitus position, injecting 6 mL, 8 mL, and 6 mL of local anesthetic at the respective levels.
Group B : Patients in the intervention group received a mixture of 10 mL of 1.33% liposomal bupivacaine (133 mg) and 10 mL of 0.5% bupivacaine hydrochloride,.
Group A: whereas those in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg).
All patients received total intravenous anesthesia during surgery. Propofol was administered at a rate of 2-4 mg/kg/h, and remifentanil was administered at a rate of 0.05-0.3 μg/kg/min to maintain a BIS value range from 40 to 60. Rocuronium will be administered and adjusted to achieve deep NMB (defined as a TOFC=0 and a post-tetanic count =1-2). Standard ventilation parameters included a respiratory rate of 10-12 breaths·min-¹ and a positive end-expiratory pressure (PEEP) of 5cmH₂O. During double-lung ventilation, a tidal volume of 8 mL/kg was used, with ETCo2 maintained between 35-45 mmHg and peak airway pressure kept below 20cmH₂O. During single-lung ventilation, the tidal volume was reduced to 6 mL/kg, with ETCo2 maintained below 60 mmHg and peak airway pressure kept below 30cmH₂O. Intravenous sufentanil (0.15 μg/kg) and ondansetron hydrochloride (8mg) were administered prior to the end of surgery. After surgery, patients were transferred to the post-anesthesia care unit (PACU) for further monitoring. Additionally, 2-4 mg/kg of sugammadex was given to reverse the residual effect of rocuronium.
In the PACU, an intravenous bolus of 0.1 μg/kg sufentanil was administered when the numeric rating scale (NRS; 0, no pain; 1-3, mild pain; 4-6, moderate pain; and 7-10, severe pain) score was ≥4. The drugs used for postoperative patient-controlled intravenous analgesia (PCIA) were sufentanil (2 μg/kg), which were diluted in 0.9% normal saline to a final volume of 100mL. The analgesia pump settings were as follows: background dose, 0 mL/h; self-controlled additional dose, 1 mL/time; and lockout time, 10 min. The patients were sent to the ward upon meeting the following criteria for at least 30 minutes: NRS score <4, an Adrelete score ≥9 and absence of other adverse reactions. The number of PCA attempts and the total drug delivery were automatically recorded by the postoperative analgesia system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: bupivacaine hydrochloride | Active comparator | Drug: Group A: bupivacaine hydrochloride;Group A: Patients in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg). |
| Group B: liposomal bupivacaine and bupivacaine hydrochloride | Experimental | Drug: GroupB:Liposomal bupivacaine and bupivacaine hydrochloride;Patients in the intervention group received a mixture of 10 mL of 1.33% liposomal bupivacaine (133 mg) and 10 mL of 0.5% bupivacaine hydrochloride. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) Age ≥18 years old;
- 2) Patients undergoing unilateral initial thoracoscopic lobectomy under general anesthesia (TV or robot-assisted);
- 3) American Society of Anesthesiologists (ASA) Grade I - III;
- 4) Voluntarily participate in the study and sign the informed consent.
Key exclusion criteria (11 listed)
- 1) Pregnant or lactating women;
- 2) Pulmonary wedge-shaped resection;
- 3) ≥2 thoracic drainage tubes;
- 4) Abnormal liver function: ALT and/or AST>2×ULN, or
- TBIL≥1.5×ULN;
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 |
|---|---|---|
| GroupB:Liposomal bupivacaine and bupivacaine hydrochloride;Group B::Patients in the intervention group received a mixture of 10 mL of 1.33% liposomal bupivacaine (133 mg) and 10 mL of 0.5% bupivacaine hydrochloride. | Drug | Group B: liposomal bupivacaine and bupivacaine hydrochloride |
| Group A: bupivacaine hydrochloride;Group A:Patients in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg). | Drug | Group A: bupivacaine hydrochloride |
Primary outcome
area under the NRS score curve (AUC) for resting
Time frame: 48hours postoperative
area under the NRS score curve (AUC) for resting and active 48 hours after surgery
5 secondary outcomes
15 quality of recovery assessments (QoR15)
Time frame: at 24, 48, and 72 hours after surgery
area under the NRS score curve (AUC) for exercise
Time frame: 48 hours after surgery
area under the NRS score curve (AUC) for resting and exercise
Time frame: 72 hours after surgery
area under the NRS score curve (AUC) for resting and exercise
Time frame: 96 hours after surgery
cumulative opioid consumption (morphine milligram equivalent, MME
Time frame: at 72 hours after 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 9 Jan 2026.
- Derived from this study: PubMed 41199334Sun Y, Guo N, Fang T, Feng Y, Liu P, Sun D, Li Y, Liu K, Ren Y, Li M, Liu Q, Yang X, Chi Y, Liu Z, Yuan L, Lang B, Yang Z, Feng N, You P, Zhang W, Su D, Wu J. Effect of preoperative thoracic paravertebral block using liposomal bupivacaine combined with drainage-tube patient-controlled analgesia on postoperative pain after thoracoscopic lobectomy: a prospective, multicentre, double-blind, randomized controlled study protocol. Perioper Med (Lond). 2025 Nov 6;14(1):122. doi: 10.1186/s13741-025-00564-2.
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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.
Sun Y tao, PH.D study chair
Shandong First 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 GroupB:Liposomal bupivacaine and bupivacaine hydrochloride; and Group A: bupivacaine hydrochloride; in people with Thoracic Paravertebral Block and Postoperative Analgesia, run by Yongtao Sun 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 4 inclusion and 11 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 9 Jan 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 yong t Sun, PH.D (18660795201, sunyongtao1979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under the NRS score curve (AUC) for resting (time frame: 48hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06165991, which also lists 1 linked publication.
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 9 Jan 2026.