acute pain after posterior thoracolumbar surgery
Conditions
Interventions
Test group:Bupivacaine liposome injection local infiltration block
control group: Ropivacaine hydrochloride injectionlocal infiltration block
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: The patient must meet all of the following criteria to be included in this study: 1. Before participating in the trial, the patient must fully understand the nature, significance, potential benefits, as well as possible inconveniences and potential risks of the trial, and be able to comprehend the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete this trial and sign the informed consent form; 2. Adult patients scheduled for the first multi-segment (2-5 segments) posterior approach thoracic and/or lumbar open surgery under general anesthesia; 3. Age between 18 and 80 years old, inclusive of both boundaries, regardless of gender; 4. American Society of Anesthesiologists (ASA) classification I to II.
Exclusion criteria
Exclusion criteria: 1. Patients who have used bupivacaine liposomes, hydrochloric bupivacaine or hydrochloric ropivacaine within the past 30 days; 2. Patients with immune deficiency disorders or mental system diseases (such as schizophrenia, depression or other cognitive disorders, etc.), or those who have difficulty communicating (such as limited cognitive ability, etc.); 3. Patients with other somatic or visceral pains that may affect postoperative pain assessment (such as having benign/malignant tumors, or patients who have undergone radical surgery and are still receiving radiotherapy/chemotherapy); 4. Patients with contraindications to postoperative analgesic drugs, or those who are known to be allergic to the components of the trial medication; 5. Patients whose screening tests reveal abnormal liver function or kidney function, including but not limited to: (1) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or total bilirubin (TBIL) >= 1.5 times the upper limit of normal (ULN); (2) Serum creatinine (Cr) >= 1.5 times ULN; (3) Dialysis patients; 6. Pregnant or lactating women patients; 7. Patients who are participating in or planning to participate in any interventional clinical trials; 8. Patients whose researchers consider are not suitable to participate in this study for any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants who did not use opioid analgesics from the end of surgery to 72 hours postoperatively.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC0–72h) of Numeric Rating Scale (NRS) pain scores at rest and during movement from trial drug administration to 72 hours postoperatively;Postoperative NRS pain scores at rest;Proportion of subjects not requiring opioid analgesics;Cumulative postoperative opioid analgesic consumption;Postoperative NRS pain scores during movement; Time to first patient-controlled intravenous analgesia (PCIA) demand for rescue analgesia (recorded to the nearest hour);Cumulative number of effective PCIA presses at 4, 24, 48, and 72 hours postoperatively; Time to first ambulation postoperatively (recorded to the nearest hour); Postoperative mobility assessment scores;Postoperative I-FEED (Intake-Feeling-Nausea-Emesis-Drainage) scoring system evaluation;Time to first oral intake postoperatively (recorded to the nearest hour); Time to first defecation postoperatively (recorded to the nearest hour); Time to first flatus postoperatively (recorded to the nearest hour);Pittsburgh Sleep Quality Index (PSQI) assessment; | — |
Countries
China
Contacts
Public ContactTianglong Wang
Xuanwu Hospital, Capital Medical University
Outcome results
None listed