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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

yong t Sun, PH.D contact

18660795201

sunyongtao1979@163.com

jian bo Wu, PH.D contact

18560083793

jianbowu@126.com

China1 site, 1 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

    Recruiting

Other trials in China

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

  1. 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 groups in NCT06165991
Study groupRoleWhat they receive
Group A: bupivacaine hydrochlorideActive comparatorGroup 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 hydrochlorideExperimentalPatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted12 Dec 2023
  2. Study start1 Jun 2024
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

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)
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

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.

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