Comparing Liposomal and Standard Bupivacaine for Pain Relief After Thoracoscopic Lung Surgery
Led by Yongtao Sun · Updated on 2026-01-09
496
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness and safety of a nerve block using bupivacaine liposome for pain relief after thoracoscopic lobectomy, a minimally invasive lung surgery. The study also explores whether bupivacaine liposome is not worse than the standard bupivacaine in managing postoperative pain. This trial is a phase 4, randomized, double-blind study focused on improving pain control after lung surgery.
Participants receive either a mixture of liposomal bupivacaine combined with standard bupivacaine or standard bupivacaine alone, administered via thoracic paravertebral nerve block at multiple spinal levels under ultrasound guidance. All patients undergo general anesthesia with intravenous agents and muscle relaxants during surgery, followed by postoperative pain management including patient-controlled intravenous analgesia using sufentanil. After surgery, patients are monitored in the post-anesthesia care unit until they meet recovery criteria before moving to the ward.
During the study, patients will be regularly assessed for pain using a numeric rating scale over 48 hours and beyond, quality of recovery scores at 24, 48, and 72 hours, and opioid consumption within 72 hours after surgery. Standard monitoring includes heart rate, blood pressure, oxygen levels, and neuromuscular function. Researchers track pain relief effectiveness, recovery quality, and safety of the nerve block treatments over the postoperative period to better understand pain control methods after thoracoscopic lung surgery.
CONDITIONS
Brief Title
Liposomal and Standard Bupivacaine in Thoracic Paravertebral Block for Post-Thoracoscopic Pain
Research Team
Y
yong t Sun, PH.D
J
jian bo Wu, PH.D
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Undergoing first unilateral thoracoscopic lobectomy under general anesthesia (including thoracoscopic or robot-assisted surgery)
American Society of Anesthesiologists (ASA) physical status Grade I to III
Voluntarily agree to participate and sign informed consent
You will not qualify if you...
Pregnant or breastfeeding women
Undergoing pulmonary wedge-shaped resection
Having two or more thoracic drainage tubes
Abnormal liver function (ALT and/or AST more than 2 times upper limit of normal, or total bilirubin 1.5 times upper limit of normal or higher)
Kidney impairment (serum creatinine above 176 bcmol/L) or dialysis treatment within 28 days before surgery
Participation in another investigational drug trial within 6 months
History of drug or alcohol abuse
Long-term opioid use (more than 3 months or more than 5 mg morphine equivalent daily for 1 month)
Allergy to local anesthetics or study drugs
Uncontrolled mental or neurological symptoms
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 - Day of surgery
Participants undergo thoracoscopic lung surgery with thoracic paravertebral nerve block using either liposomal bupivacaine combined with bupivacaine hydrochloride or bupivacaine hydrochloride alone, followed by standard anesthesia and postoperative pain management.
1 surgery visit including anesthesia and nerve block procedures
Post-operative Follow-up
Duration - Up to 4 days after surgery
Participants are monitored for pain and recovery after surgery, including assessments of pain scores and quality of recovery.
Assessments at 24, 48, 72, and 96 hours after surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.