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Efficacy and safety of bupivacaine liposome in eriospinoplane nerve block after thoracoscopic thoracic surgery

Efficacy and safety of eriospinoplane nerve block with bupivacaine liposomes for postoperative analgesia after thoracoscopic thoracic surgery: a single-center, randomized, single-blind, positive drug controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097255
Enrollment
Unknown
Registered
2025-02-17
Start date
2025-02-17
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Chronic postsurgical pain

Interventions

Group A (bupivacaine liposome group):T6 erector spinal plane nerve block was performed by injecting bupivacaine liposome 266mg under B-ultrasound guidance
Group B (ropivacaine hydrochloride group):T6 erector spinal plane nerve block was performed by injecting ropivacaine hydrochloride 75mg under B-ultrasound guidance

Sponsors

The Sixth Affiliated Hospital, South China University of Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. The subjects have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign the informed consent; 2. Patients undergoing thoracoscopic thoracic surgery under general anesthesia; 3. Age >=18 years old, gender unlimited; 4. 18 kg/m^2<= BMI <=30 kg/m^2; 5. American Society of Anesthesiologists (ASA) Grade I - III.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to bupivacaine liposomes, ropivacaine hydrochloride, opioids, or any other ingredients or components that may be used in the study. 2. Patients with a history of long-term use of narcotic analgesics, sedatives, or nonsteroidal anti-inflammatory drugs (NSAIDs). 3. Patients who have systemic hypotension that does not respond to vasoactive drugs. 4. Patients with bradycardia, defined as a heart rate of less than 55 beats per minute. 5. Patients with high-degree atrioventricular block without a pacemaker. 6. Patients who have sustained craniocerebral injury and are experiencing intracranial hypertension. 7. Patients with severe dysfunction of the heart, lungs, liver, or kidneys. 8. Patients with a history of allergic diseases, malignant hyperthermia, or epilepsy. 9. Subjects with a history of mental illness or cognitive dysfunction. 10. Patients with disorders of fat metabolism. 11. Patients who are anticipated to have difficulty with intubation. 12. Patients with myasthenia gravis. 13. Subjects with sensory disorders, including but not limited to hyperalgesia. 14. Patients with a history of alcoholism. 15. Patients with severe visual or hearing impairments. 16. Patients who are unable to cooperate and complete post-surgical tests. 17. Patients for whom the investigator determines that there are other circumstances making them unsuitable for participation in the clinical trial.

Design outcomes

Primary

MeasureTime frame
QoR-15 score 6 hours after surgery;VAS score 6 hours after surgery;QoR-15 score 12 hours after surgery;VAS score 12 hours after surgery;QoR-15 score 24 hours after surgery;VAS score 24 hours after surgery;QoR-15 score 48 hours after surgery;VAS score 48 hours after surgery;QoR-15 score 72 hours after surgery;VAS score 72 hours after surgery;Patient satisfaction;

Secondary

MeasureTime frame
Cumulative opioid consumption in 72 hours after surgery;Incidence of postoperative pulmonary complications;The number of times the patient applied the analgesic pump in the 72h after surgery;Postoperative recovery time;

Countries

China

Contacts

Public ContactGuo Lideng

The Sixth Affiliated Hospital, South China University of Technology

gldeng@foxmail.com+86 137 5121 5532

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026