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A prospective randomized controlled clinical trial of the analgesic efficacy and safety of liposomal bupivacaine for thoracic paravertebral block in thoracic surgery

A prospective randomized controlled clinical trial of the analgesic efficacy and safety of liposomal bupivacaine for thoracic paravertebral block in thoracic surgery - LBTPVB-RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124172
Enrollment
Unknown
Registered
2026-05-08
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute postoperative pain after thoracic surgery

Interventions

RPB group:Ultrasound-guided single-shot thoracic paravertebral block with 20 mL of 0.375% ropivacaine .
LBB group:Ultrasound-guided single-shot thoracic paravertebral block with liposomal bupivacaine 133 mg (10 mL) diluted with 10 mL normal saline to a total volume of 20 mL.

Sponsors

The Second Affiliated Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Voluntary participation with written informed consent; 2.age between 18 and 65 years; 3. either sex; 4. body mass index between 19.0 and 26.0 kg/m^2; 5.American Society of Anesthesiologists physical status II–III; 6. scheduled for elective thoracoscopic lobectomy at the Second Affiliated Hospital of Shandong First Medical University.

Exclusion criteria

Exclusion criteria: 1. Refusal of paravertebral nerve block: Patients who voluntarily refuse to receive paravertebral block treatment will not be included in the study; 2. History of allergies or immune-related diseases: Patients with known allergy to bupivacaine, or those suffering from immune-related diseases such as asthma, urticaria, or eczema, will be excluded; 3. Chest wall injury or infection: Patients with trauma, infection, or other local lesions in the chest wall area, which make effective nerve block impossible, do not meet the inclusion criteria; 4. Abnormal coagulation function: If preoperative test results show an APTT value exceeding 33.8 seconds or a PT value higher than 12.1 seconds, indicating abnormal coagulation function, the patient is not suitable for participation in the study; 5. History of chronic neuropathic pain: Patients with a history of chronic neuropathic pain may affect the effectiveness of nerve block and the accuracy of study results, and thus will not be included; 6. Participation in other clinical trials: Patients currently participating in other clinical studies may interfere with the results of this study and therefore do not meet the inclusion requirements.

Design outcomes

Primary

MeasureTime frame
Resting VAS pain scores at 1, 12, 24, 48, and 72 hours after surgery;Coughing VAS pain scores at 1, 12, 24, 48, and 72 hours after surgery;Cumulative opioid consumption within 72 hours after surgery;Incidence of opioid-related adverse events;

Secondary

MeasureTime frame
Quality of recovery assessed by QoR-15;Sleep quality;Anxiety and depression status;

Countries

China

Contacts

Public ContactWensheng Zhang

The Second Affiliated Hospital of Shandong First Medical University

zhwsh1968@sina.com+86 139 5384 6968

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026