Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06165991

The Effect of Bupivacaine Liposome Combined With Bupivacaine Hydrochloride on Thoracic Paravertebral Nerve Block for Postoperative Pain After Thoracoscopic Lung Surgery

Led by Yongtao Sun · Updated on 2026-01-09

496

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years old or older
  • 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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 - 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

Trial Site Locations

Total: 1 location

1

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

Jinan, Shandong, China, 250014

Actively Recruiting

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Research Team

Y

yong t Sun, PH.D

J

jian bo Wu, PH.D

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.

Yongtao Sun, Na Guo, Tinghao Fang...

https://pubmed.ncbi.nlm.nih.gov/41199334