Posterior spinal fusion
Conditions
Interventions
experimental group:Bupivacaine liposome injection local infiltration block
control group:Ropivacaine hydrochloride injection local infiltration block
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to enter the study: 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, willing to strictly follow the clinical trial protocol to complete this trial and sign the informed consent; 2. Adult patients undergoing primary multi-stage posterior spinal fusion under general anesthesia (spinal fusion at 2 to 4 segments thoracolumbar and below); 3. Age 18 and above, regardless of gender; 4. American Society of Anesthesiologists (ASA) Grade I to II.
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria were excluded from the study: 1. Received bupivacaine liposomes, bupivacaine hydrochloride, or ropivacaine hydrochloride solution within the last 30 days 2. Subjects with immunodeficiency diseases or mental system diseases (such as schizophrenia, depression, etc.) and difficulty in communication; 3. Subjects with other somatic or visceral pain that may affect the evaluation of postoperative pain; 4. Patients with contraindications related to postoperative analgesics 5. Liver function tests (aspartate aminotransferase (AST) or/and alanine aminotransferase (ALT) and/or total bilirubin (TBIL) =1.5×ULN) or abnormal renal function tests (serum creatinine (Cr) =1.5×ULN, or dialysis subjects) during screening 6. Pregnant or lactating female subjects 7. Patients who are participating or planning to participate in any interventional clinical trial 8. The investigator considers that there are any other reasons why the patient is not eligible to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS;NRS score in the state of postoperative exercise (or cough) (definition: pain intensity score when the patient gets out of bed;Cumulative use of opioid analgesics;Proportion of patients who applied PCIA for relief analgesia after surgery;Time to apply first PCIA relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| First time to get out of bed within 3 days after surgery ;Nausea and vomiting score within 3 days after surgery;Sleep quality scores on the day of surgery, the first day after surgery, the second day and the third day after surgery;Time of first feeding within 3 days after surgery;Time of first defecation within 3 days after surgery;Time of first anal exhaust after surgery ;Activity status score within 3 days after surgery;Length of stay; | — |
Countries
China
Contacts
Public ContactTianlong Wang
Xuanwu Hospital, Capital Medical University
Outcome results
None listed