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This is a single-center, randomized, controlled, double-blind clinical trial. A total of 148 patients undergoing elective open upper abdominal surgery will be included and randomly assigned 1:1 to receive ultrasound-guided erector spinae plane block with liposome bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The primary outcome is the AUC of resting pain scores from 0 to 72 hours postoperatively. This study aims to evaluate the analgesic efficacy and safety of liposome bupivacaine and provide a long-acting and safe postoperative analgesia strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine Combined Intervention Arm | Experimental | Patients in this arm receive ultrasound-guided bilateral T7 erector spinae plane block with a mixed solution of liposomal bupivacaine and conventional bupivacaine hydrochloride, for postoperative analgesia after elective open upper abdominal surgery. |
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| Conventional Bupivacaine Single Agent Arm | Active Comparator | Patients in this arm receive ultrasound-guided bilateral T7 erector spinae plane block with conventional bupivacaine hydrochloride alone for postoperative analgesia after elective open upper abdominal surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine plus bupivacaine hydrochloride | Drug | This intervention uses a combination of liposomal bupivacaine and standard bupivacaine hydrochloride for T7 bilateral erector spinae plane block. The liposomal formulation provides prolonged local analgesic effect, which differentiates it from the control intervention that uses only conventional bupivacaine hydrochloride without long-acting liposomal components. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of resting pain score within 0-72 hours after operation | Calculate the area under the curve (AUC) of resting visual analog scale (VAS) pain scores at multiple time points within 0 to 72 hours after open upper abdominal surgery, to comprehensively evaluate the overall postoperative analgesic effect. | Postoperative 0 to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative adverse reaction incidence | Observe and record the incidence of postoperative adverse reactions including nausea, vomiting, dizziness and neurological complications in all patients. | Postoperative 0-72 hours |
| Time to first ambulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Liang | Contact | 15858281360 | keyanlunli_zheer@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | China |
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| Bupivacaine hydrochloride monotherapy | Drug | This intervention adopts single-agent conventional bupivacaine hydrochloride for bilateral T7 erector spinae plane block, without adding liposomal bupivacaine. It serves as the conventional analgesia regimen and is different from the combined regimen supplemented with long-acting liposomal bupivacaine in the experimental group. |
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Record the time from the end of surgery to the first off-bed ambulation of patients.
| Within 7 days after surgery |
| Postoperative hospital stay | Record the total length of postoperative hospital stay for each patient. | From the start of surgery to discharge, the average is ten days |
| Dynamic VAS pain score at each time point | Compare resting and dynamic Visual Analogue Scale (VAS) pain scores between the two groups. The VAS is a 10-cm scale ranging from 0 to 10, where 0 = no pain and 10 = worst possible pain (higher scores indicate worse outcomes). | At 2, 6, 12, 24, 48, and 72 hours postoperatively. |
| Dynamic VAS pain score at each time point | Compare resting and dynamic VAS pain scores at postoperative 2h, 6h, 12h, 24h, 48h and 72h between two groups. | Postoperative 2 hours (h), 6h, 12h, 24h, 48h, 72 hours (h) |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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