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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Patients in this group will receive transversus abdominis plane (TAP) block with liposomal bupivacaine after surgery. |
|
| Ropivacaine group | Active Comparator | Patients in this group will receive transversus abdominis plane (TAP) block with Ropivacaine after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine TAP block | Drug | Liposomal bupivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative dynamic NRS pain score at 24 hours | 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). | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative NRS pain scores at different time points | NRS scores at 24, 48, and 72 hours post-surgery while at rest; NRS scores at 48 and 72 hours while active | 24, 48, and 72 hours after surgery |
| Postoperative recovery quality (QoR-15 scale) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of chronic post-surgical pain (CPSP) at 3 months | The incidence of chronic post-surgical pain will be assessed via telephone follow-up.Incidence of chronic post-surgical pain (CPSP) , defined as persistent pain (NRS ≥ 1) at the surgical site lasting ≥ 3 months after laparoscopic cholecystectomy, excluding pain caused by other etiologies. | 3 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ke yu Zhang | Contact | +86 19861121816 | m456365zky@163.com | |
| Lili Jia | Contact | +86 13102058301 | jialili19880801@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenli Yu | Tianjin First Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin First Central Hospital | Recruiting | Tianjin | Tianjin Municipality | 300384 | China |
Individual participant data (IPD) will be made available upon reasonable request to the corresponding author, beginning 12 months after the publication of the primary results manuscript.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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.
| Ropivacaine TAP blocks | Drug | Standard-dose ropivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy. |
|
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.
| 24, 48, and 72 hours after surgery |
| Time to first rescue analgesia | 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）. | Up to 72 hours after surgery |
| Total postoperative analgesic consumption within 72 hours | 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. | 72 hours after surgery |
| Gastrointestinal function recovery | Time to first flatus and time to first defecation, measured from the end of surgery. | Postoperatively, through hospital discharge, up to 7 days after surgery |
| Postoperative length of hospital stay | The total number of days from surgery to hospital discharge will be recorded. | Postoperatively, through hospital discharge (up to 7 days) |
| Incidence of adverse events | Adverse events including nausea, vomiting, dizziness, local anesthetic toxicity, and neurological complications will be recorded and compared between groups during hospitalization and follow-up. | Postoperatively, through hospital discharge, and at follow-up (up to 7 days after surgery) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |