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Study on the efficacy and safety of bupivacaine liposome combined with ropivacaine for postoperative analgesia in patients undergoing thoracoscopic surgery

Study on the efficacy and safety of bupivacaine liposome combined with ropivacaine for postoperative analgesia in patients undergoing thoracoscopic surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127996
Enrollment
Unknown
Registered
2026-07-12
Start date
2026-03-03
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Postoperative analgesia

Interventions

Control group:Inject 4 mL of 0.33% bupivacaine liposome at the incision segment, and inject 10 mL of 0.665% bupivacaine liposome into each adjacent segment above and below the incision.
Experimental group:Inject 6 mL of 0.33% ropivacaine into the segment corresponding to the incision, and simultaneously inject 10 mL of 0.665% liposomal bupivacaine into the adjacent segments above and

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 65 years (gender not limited), with a BMI of 18.5 to 28 kg/m² and ASA grades I to III 2. Patients who are scheduled to undergo elective thoracoscopic resection of lung lesions (including segmental, wedge-shaped or lobectomy) 3. Be capable of correctly understanding and evaluating VAS scores, and be able to use intravenous PCIA electronic analgesia pumps correctly 4. Before and after the operation, the patient was conscious and communicated smoothly, and was able to cooperate to complete the follow-up assessment 5. Subjects who voluntarily participate in and sign the informed consent form and are willing to undergo follow-up

Exclusion criteria

Exclusion criteria: 1. During the operation, the surgical method was modified to thoracotomy or the resection range was expanded 2. Two or more thoracoscopic surgeries 3. Women who are pregnant, breastfeeding or planning to become pregnant during the trial period 4. Combined with severe heart, lung, liver and kidney function disorders (such as serum creatinine 2 mg/dL, or liver enzymes 3 times the upper limit of normal) 5. Combined with severe coagulation dysfunction or with a clear bleeding tendency 6. There is a history of local anesthetic allergy or contraindications for paravertebral block operations (such as injection site infection, spinal deformity, severe pleural adhesion) 7. There is a long-term history of chronic pain (3 months) or regular use of opioid drugs (=15 days within 30 days before surgery, with an average of 15mg of morphine equivalent per day) 8. There are neurological diseases or mental disorders that affect pain perception or evaluation (such as dementia, severe anxiety/depression, previous spinal cord injury, etc.) 9. Patients who require mechanical ventilation support before the operation 10. Previously received paravertebral block of the thoracic vertebrae or had related neurological deficits 11. Currently participating in other clinical trials, or having participated in other clinical research within the past 30 days 12. Other circumstances that the researchers consider unsuitable for participation in this trial

Design outcomes

Primary

MeasureTime frame
VAS score at different time points after surgery;

Secondary

MeasureTime frame
Cumulative postoperative analgesic drug morphine consumption equivalent;Time to first require additional analgesic medication after surgery;Overall Benefit of Analgesia Score;QoR-15 score;Postoperative recovery related indicators;Security indicators;

Countries

China

Contacts

Public ContactLiu Jian

Shanghai Tenth People's Hospital

liuj_7610@msn.com+86 180 5202 4248

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026