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Efficacy and safety of bupivacaine liposome injection combined with routine treatment in early postoperative analgesia in patients undergoing lumbar surgery: a single center, prospective cohort study

Efficacy and safety of bupivacaine liposome injection combined with routine treatment in early postoperative analgesia in patients undergoing lumbar surgery: a single center, prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115274
Enrollment
Unknown
Registered
2025-12-24
Start date
2025-12-25
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Pain after lumbar surgery

Interventions

Exposure group:None

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Subjects can understand the procedures and methods of this clinical trial (including pain intensity assessment methods), and after full informed consent, they voluntarily participate, and the informed consent form is signed by the subjects themselves or legal guardians. 2.Patients who need single-level or multi-level lumbar decompression or (and) decompression and fusion due to illness. 3.Subjects were classified as I-III according to the classification standard of American Society of Anesthesiologists (ASA). 4.When signing the informed consent form, the person is 18<=age <=80 years old, regardless of gender. 5.Female or male subjects of childbearing age must agree to take effective contraceptive measures by themselves and their partners within 30 days after signing the informed consent.

Exclusion criteria

Exclusion criteria: 1.Those who are allergic to amide local anesthetics (such as lidocaine, bupivacaine, tetracaine and ropivacaine, etc.), opioid drugs or any components of drugs used in this experiment, or have a history of idiopathic reactions, or those who are allergic (such as allergic to two or more drugs, food or pollen). 2.Physical conditions (such as rheumatoid arthritis, chronic neuropathic pain, etc.) unrelated to single-level or multi-level lumbar decompression or decompression and fusion may confuse postoperative pain assessors. 3.Coagulation dysfunction (platelet < 50× 10^9/L), patients with high bleeding risk, severe liver dysfunction (Child-Pugh C grade), severe renal dysfunction (receiving dialysis treatment before operation) and severe cardiovascular dysfunction. 4.Pregnant and lactating women who are currently breastfeeding or who have not been artificially breastfed but are less than 6 months after delivery. 5.The researcher thinks that it will be impossible to evaluate the curative effect or impossible to complete the expected course of treatment and follow-up, which is not suitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
Consumption of opioid analgesics;

Secondary

MeasureTime frame
Adverse event;Overall satisfaction score of subjects with analgesia;Vital signs;Numerical rating scale;Electrocardiogram;Postoperative hospitalization time;Laboratory examination;Time of first receipt of remedial analgesic medication;Overall satisfaction score of researchers on analgesia;Consumption of non-opioid analgesic drugs;

Countries

China

Contacts

Public ContactYu Yang

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

270539179@qq.com+86 28 87783481

Outcome results

None listed

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