Liposomal and Standard Bupivacaine in Thoracic Paravertebral Block for Post-Thoracoscopic Pain

The Effect of Bupivacaine Liposome Combined With Bupivacaine Hydrochloride on Thoracic Paravertebral Nerve Block for Postoperative Pain After Thoracoscopic Lung Surgery

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 with standard bupivacaine

Study Overview

• Status: Recruiting
• Conditions: Postoperative Analgesia; Thoracic Paravertebral Block; Thoracoscopic Lobectomy
• Intervention / Treatment: Drug: Group A: bupivacaine hydrochloride;; Drug: GroupB:Liposomal bupivacaine and bupivacaine hydrochloride

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 Type: Interventional
• Enrollment (Estimated): 496
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: yong T Sun, PH.D; Phone Number: 18660795201; Email: sunyongtao1979@163.com
• Study Contact Backup: Name: jian bo Wu, PH.D; Phone Number: 18560083793; Email: jianbowu@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
      • Contact: yong T Sun, PH.D; Phone Number: 18660795201; Email: sunyongtao1979@163.com
      • Contact: yong T Sun; Phone Number: 18660795201; Email: sunyongtao1979@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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; Group A:Patients in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg).
Experimental: Group B: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
area under the NRS score curve (AUC) for resting	area under the NRS score curve (AUC) for resting and active 48 hours after surgery	48hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at 24, 48, and 72 hours after surgery
cumulative opioid consumption (morphine milligram equivalent, MME	cumulative opioid consumption at 72 hours after surgery (morphine milligram equivalent, MME	at 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	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	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	96 hours after surgery

Collaborators and Investigators

• Sponsor: Yongtao Sun
• Investigators: Study Chair: Sun Y tao, PH.D, Shandong First Medical University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative analgesia; thoracoscopic lobectomy; liposomal bupivacaine(LB); Thoracic paravertebral nerve block
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: liposomal bupivacaine LB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No