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

NCT06165991 | Recruiting Phase 4

• 1 other identifier: liposomal bupivacaine LB
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 1

Brief 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 with standard bupivacaine

Conditions

Thoracic Paravertebral Block; Postoperative Analgesia; Thoracoscopic Lobectomy

Keywords

liposomal bupivacaine(LB); Thoracic paravertebral nerve block; Postoperative analgesia; thoracoscopic lobectomy

Outcome Measures

Primary Outcomes (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

  48hours postoperative

Secondary Outcomes (5)

• 15 quality of recovery assessments (QoR15)

  at 24, 48, and 72 hours after surgery

• area under the NRS score curve (AUC) for exercise

  48 hours after surgery

• area under the NRS score curve (AUC) for resting and exercise

  72 hours after surgery

• area under the NRS score curve (AUC) for resting and exercise

  96 hours after surgery

• cumulative opioid consumption (morphine milligram equivalent, MME

  at 72 hours after surgery

Study Arms (2)

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).

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.

Drug: GroupB:Liposomal bupivacaine and bupivacaine hydrochloride;

Interventions

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 B: liposomal bupivacaine and 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).

Group A: bupivacaine hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age ≥18 years old;
• \) Patients undergoing unilateral initial thoracoscopic lobectomy under general anesthesia (TV or robot-assisted);
• \) American Society of Anesthesiologists (ASA) Grade I - III;
• \) Voluntarily participate in the study and sign the informed consent.

You may not qualify if:

• \) Pregnant or lactating women;
• \) Pulmonary wedge-shaped resection;
• \) ≥2 thoracic drainage tubes;
• \) Abnormal liver function: ALT and/or AST\>2×ULN, or
• TBIL≥1.5×ULN;
• \) Renal function impairment (serum creatinine \>176μmol/L), or received dialysis treatment within 28 days before surgery;
• \) Participate in another research trial involving an investigational drug within 6 months;
• \) A history of drug or alcohol abuse;
• \) Long-term use of opioids (more than 3 months or more than 5 mg daily morphine equivalent per day for 1 month);
• \) History of allergy to local anesthetics or one of the investigational drugs;
• \) Uncontrolled mental or neurological symptoms.

Sponsors & Collaborators

• Yongtao Sun: lead

Study Sites (1)

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Jinan, Shandong, 250014, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41199334 DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sun Y tao, PH.D

  Shandong First Medical University

  STUDY CHAIR

Central Study Contacts

yong t Sun, PH.D

CONTACT

18660795201; sunyongtao1979@163.com

jian bo Wu, PH.D

CONTACT

18560083793; jianbowu@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 12, 2023
• Study Start: June 1, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

CN (1)