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
Yongtao Sun
496 participants
Jun 1, 2024
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
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
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:Patients in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06165991