Skip to content

Efficacy and safety analysis of bupivacaine liposomes used in posterior laminar block for postoperative analgesia in patients undergoing posterior approach lumbar surgery

Efficacy and safety analysis of bupivacaine liposomes used in posterior laminar block for postoperative analgesia in patients undergoing posterior approach lumbar surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091488
Enrollment
Unknown
Registered
2024-10-29
Start date
2024-11-15
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Pain after posterior approach lumbar surgery

Interventions

Bupivacaine liposome group:Bupivacaine liposomes 10mL(133mg)+ saline 20mL, 15mL on each side
Bupivacaine group:Bupivacaine hydrochloride 5mL(75mg)+ normal saline 25ml, 15mL on each side

Sponsors

the Second Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Before the test, understand the nature, significance, possible benefits, possible inconvenience and potential risks of the test in detail. Able to understand the procedures and methods of this study, and willing to strictly follow the clinical trial protocol to complete this study; 2. Posterior approach lumbar surgery should be performed at an appropriate time. 3. Age 18-65 years old; 4. American Society of Anesthesiologists (ASA) Grade I ~ III; 5. Consent of patients and their families was obtained before surgery, and informed consent was signed.

Exclusion criteria

Exclusion criteria: 1. Received bupivacaine liposomes or bupivacaine hydrochloride within the last 30 days. 2. Patients with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, AIDS or malignant tumors) or who used immunosuppressants within 30 days before surgery. 3. Patients with a history of psychiatric diseases (such as schizophrenia, depression, etc.) or difficulties in communication. 4. Patients with a history of chronic pain or visceral pain. 5. Patients with abnormal liver and kidney function. 6. Patients with clinically significant abnormal heart rate or heartbeat rhythm during the screening period. 7. The investigator believes that there are any other reasons why the patient is not eligible to participate in the study.

Design outcomes

Primary

MeasureTime frame
Blood concentration of bupivacaine;Patient visual analogue score (VAS);Time to first use of a pressure relief pump (accurate to hours) and additional remedial analgesia usage;Cumulative use of opioids;

Secondary

MeasureTime frame
Intraoperative consumption of propofol and remifentanil;QoR-15 score;Complications;overlengthy case in hospital stays;

Countries

China

Contacts

Public ContactWang Yingbin

the Second Hospital of Lanzhou University

Wangyingbin6@163.com+86 138 9313 3264

Outcome results

None listed

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