Liposomal Bupivacaine, Postoperative Pain
Conditions
Keywords
Liposomal Bupivacaine, Postoperative Pain, Transverse Abdominal Plane Block, Anesthetic Recovery
Brief summary
This is a single-center, randomized, single-blind, parallel-group clinical trial. The study aims to compare the analgesic efficacy of liposomal bupivacaine versus ropivacaine for transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. Eligible participants will be randomly assigned to receive either liposomal bupivacaine or ropivacaine for TAP block during surgery. The primary outcome is the dynamic NRS pain score at 24 hours after surgery. Secondary outcomes include static and dynamic NRS pain scores at multiple time points, QoR-15 recovery quality, time to first rescue analgesia, analgesic consumption, gastrointestinal function recovery, length of hospital stay, and adverse events. Participants will be followed up to 3 months after surgery to evaluate the incidence of chronic post-surgical pain (CPSP). All participants will receive routine clinical care, and participation is voluntary.
Interventions
Liposomal bupivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.
DRUGRopivacaine TAP blocks
Standard-dose ropivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.
Sponsors
Tianjin First Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This is a single-blind trial with blinded outcome assessment. The patients, outcome assessors, and statistical analysts are blinded to the group allocation. Only the anesthesiologist performing the transversus abdominis plane (TAP) block is aware of the treatment assignment, to ensure the safety and standardization of the procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years, either gender. * Patients scheduled for elective laparoscopic cholecystectomy. * ASA physical status I-III. * Able to provide written informed consent and complete the 3-month follow-up.
Exclusion criteria
* History of allergy to local anesthetics. * History of dementia, psychosis, or other central nervous system diseases. * History of chronic pain or long-term use of opioids or other analgesics. * Contraindications to nerve block: infection at puncture site, severe coagulopathy. * Severe hepatic or renal dysfunction, pregnancy, or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative dynamic NRS pain score at 24 hours | 24 hours after surgery | Postoperative pain intensity under dynamic conditions (e.g., coughing or deep breathing) will be assessed using the Numerical Rating Scale (NRS, 0-10, where 0 = no pain and 10 = worst imaginable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative NRS pain scores at different time points | 24, 48, and 72 hours after surgery | NRS scores at 24, 48, and 72 hours post-surgery while at rest; NRS scores at 48 and 72 hours while active |
| Postoperative recovery quality (QoR-15 scale) | 24, 48, and 72 hours after surgery | Postoperative recovery quality will be evaluated using the 15-item Quality of Recovery (QoR-15) scale at 24 hours after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery quality. |
| Time to first rescue analgesia | Up to 72 hours after surgery | The time from the end of surgery to the first request for rescue analgesia (e.g., opioid or non-opioid analgesics) will be recorded（background pain is excluded）. |
| Total postoperative analgesic consumption within 72 hours | 72 hours after surgery | Total amount of rescue analgesics (e.g., opioids, NSAIDs) used by each patient within 72 hours after surgery will be calculated and converted into equivalent doses. |
| Gastrointestinal function recovery | Postoperatively, through hospital discharge, up to 7 days after surgery | Time to first flatus and time to first defecation, measured from the end of surgery. |
| Postoperative length of hospital stay | Postoperatively, through hospital discharge (up to 7 days) | The total number of days from surgery to hospital discharge will be recorded. |
| Incidence of adverse events | Postoperatively, through hospital discharge, and at follow-up (up to 7 days after surgery) | Adverse events including nausea, vomiting, dizziness, local anesthetic toxicity, and neurological complications will be recorded and compared between groups during hospitalization and follow-up. |
Countries
China
Contacts
CONTACTKe yu Zhang
CONTACTLili Jia
STUDY_DIRECTORWenli Yu
Tianjin First Central Hospital
Outcome results
None listed