RecruitingPhase 4NCT06165991

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


Sponsor

Yongtao Sun

Enrollment

496 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • \) 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.

Exclusion Criteria11

  • \) 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.

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Interventions

DRUGGroupB: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.

DRUGGroup A: bupivacaine hydrochloride;

Group A:Patients in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg).


Locations(1)

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

Jinan, Shandong, China

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NCT06165991


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