Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
ID07432711

The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Local Incisional Infiltration for Postoperative Pain in Patients Undergoing Video-assisted Thoracoscopic Surgery: A Multi-Center Randomized Controlled Trial

Led by Beijing Tiantan Hospital · Updated on 2026-03-06

100

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of liposomal bupivacaine combined with bupivacaine compared to bupivacaine alone for managing pain after video-assisted thoracoscopic surgery (VATS), a less invasive lung surgery. The study addresses the high rate of acute pain after VATS, which can lead to chronic pain and affect recovery and quality of life if not properly managed. Current evidence on the superiority of liposomal bupivacaine is mixed, so this study aims to provide clearer results through a randomized controlled trial. Participants will receive either a local infiltration of 40 mL of 0.25% bupivacaine hydrochloride alone or a mixture of 20 mL liposomal bupivacaine with 20 mL 0.25% bupivacaine hydrochloride. This infiltration is administered by a thoracic surgeon at the incision site before closing the surgical wound. Postoperatively, all patients have access to patient-controlled analgesia with sufentanil and ondansetron, and if needed, oral oxycodone with acetaminophen or intravenous morphine may be given. The study monitors analgesic use and pain control during the first 72 hours after surgery. Participants will be closely monitored for pain levels using numeric rating scales at rest and during movement at multiple time points up to 3 months after surgery. Researchers will also track the amount of opioid medication used, patient satisfaction, sedation levels, recovery quality, length of hospital stay, and any side effects such as nausea and vomiting. The primary outcome is the amount of morphine-equivalent rescue pain medication used within 48 hours post-surgery. The study is expected to conclude by June 2027, with participants aged 18 to 64 years undergoing elective VATS procedures.

CONDITIONS

Brief Title

The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective video-assisted thoracoscopic lobectomy or wedge resection under general anesthesia
  • Ages 18 to 64 years old
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Glasgow Coma Scale (GCS) score of 15
  • Ability to understand the study and provide informed consent
Not Eligible

You will not qualify if you...

  • History of chronic pain syndrome
  • Heart conduction block such as sinus block or atrioventricular block
  • Unstable coronary artery disease
  • Gastric ulcer or gastric bleeding
  • Diabetes treated with insulin
  • Coagulation dysfunction or ongoing oral anticoagulant use not stopped before surgery
  • Abnormal liver function with ALT or AST more than twice the upper limit
  • Renal impairment or recent dialysis treatment
  • History of mental illness or current psychotropic medication use
  • Excessive alcohol or drug abuse, chronic opioid use, or recent use of painkillers before surgery
  • Pregnancy or breastfeeding
  • Extreme body mass index (BMI less than 15 or greater than 35)
  • Participation in another interventional trial affecting this study
  • Allergy to local anesthetics or study drugs

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 72 hours postoperatively

Participants undergo video-assisted thoracoscopic surgery and receive either liposomal bupivacaine plus bupivacaine or bupivacaine hydrochloride via local infiltration before incision closure to relieve postoperative pain.

Postoperative monitoring visits at 2, 24, 48, and 72 hours

Follow-up

Duration - 3 months postoperatively

Participants are assessed for pain and recovery at 1 week, 1 month, and 3 months after surgery to monitor longer-term outcomes and medication use.

Visits at 1 week, 1 month, and 3 months

Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

F

Fang Luo

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Liposomal bupivacaine vs. Ropivacaine for wound infiltration on chronic postsurgical pain after video-assisted thoracoscopic lung surgery: protocol for a randomized, double-blind, controlled trial.

Han-Xue Zhao, Wei Dou, Xin-Tong Meng...

https://pubmed.ncbi.nlm.nih.gov/40760826

Comparison of intraoperative and post-operative effects of serratus anterior plane block performed with ultrasound and infiltration block in patients undergoing video-assisted thoracoscopic surgery.

Mustafa Dikici, Selcan Akesen, Belgin Yavaşcaoğlu...

https://pubmed.ncbi.nlm.nih.gov/34988957