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This trial is designed to compare the post-operative analgesic efficacy and safety of liposomal bupivacaine versus plain bupivacaine when both are used for ultrasound-guided combined suprascapular and axillary nerve block in patients undergoing elective arthroscopic shoulder surgery.
Most liposomal bupivacaine data come from ultrasound-guided brachial-plexus blocks; evidence for its safety and efficacy when used specifically for a combined ultrasound-guided suprascapular-plus-axillary block after arthroscopic shoulder surgery is still missing. This trial fills that gap by comparing liposomal bupivacaine with bupivacaine along, aiming to advance multimodal analgesia and enhanced-recovery pathways, cut postoperative pain and stress, and shorten hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (liposomal bupivacene） | Experimental | In the experimental group, 15 mL of a mixture containing liposomal bupivacaine plus plain bupivacaine is deposited around each target nerve (20 mL liposomal bupivacene, 266 mg, combined with 10 mL 0.75 % plain bupivacaine, total 30 mL). |
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| Group B（bupivacene） | Active Comparator | The control group receives 15 mL of 0.25 % plain bupivacaine around each nerve. Unlike the clear solution of plain bupivacaine, liposomal bupivacaine has a distinctive milky-white appearance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A（ liposomal bupivacene） | Drug | In the experimental group, 15 mL of a mixture containing liposomal bupivacaine plus plain bupivacaine is deposited around each target nerve (20 mL liposomal bupivacene, 266 mg, combined with 10 mL 0.75 % plain bupivacaine, total 30 mL). |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption after surgery | The primary outcome entails tracking and assessing the total opioid consumption by participants following arthroscopic shoulder surgery. The consumption of Opioid via patient-controlled analgesia will be recorded within 72h postoperatively. | The outcome will be monitored and recorded within 72 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic efficacy after surgery | To compare the analgesic efficacy of liposomal bupivacaine versus plain bupivacaine when used in ultrasound-guided combined suprascapular and axillary nerve block for arthroscopic shoulder surgery, VAS pain scores will be recorded at several time points from 0 to 72h. | The outcome will be monitored and recorded within 72 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Xia | Contact | +8615623068980 | jamesxia@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Mei | Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
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Because liposomal bupivacaine is a milky-white suspension that cannot be disguised, the investigator who performs the block cannot be blinded; the study therefore uses a double-blind design in which both participants and outcome assessors remain unaware of group allocation.
| Group B（bupivacene） | Drug | The control group receives 15 mL of 0.25 % plain bupivacaine around each nerve. Unlike the clear solution of plain bupivacaine, liposomal bupivacaine has a distinctive milky-white appearance. |
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| Operative time | Total duration of surgery from skin incision to skin closure, measured in minutes | Intraoperative |
| Length of hospital stay | Duration of hospitalization from admission to discharge, measured in days | Through study completion, up to 7 days |
| Incidence of Allergic Reactions | Mild allergic reactions including skin rash, pruritus, urticaria, or local injection site reactions, graded using CTCAE v5.0 criteria | From first dose to 3 days postoperatively |
| Incidence of Nerve Injury | Nerve injury related to suprascapular and axillary nerve block procedure, assessed by neurological examination including motor function, sensory testing, and presence of paresthesia or dysesthesia in the blocked limb | From time of nerve block procedure to 7 days postoperatively |
| Incidence of Respiratory Depression | Respiratory depression defined as respiratory rate < 8 breaths per minute, oxygen saturation < 90%, or need for respiratory support/intervention, assessed by continuous monitoring in PACU | within 24 hours postoperatively |
| Incidence of Local Anesthetic Systemic Toxicity (LAST) | Local anesthetic systemic toxicity events including central nervous system symptoms (confusion, seizures, loss of consciousness) and cardiovascular symptoms (arrhythmias, hypotension, cardiac arrest) assessed using standardized LAST criteria | From time of nerve block injection to 6 hours post-procedure |
| Incidence and Severity of Postoperative Nausea and Vomiting (PONV) | Composite outcome of postoperative nausea and vomiting assessed by patient-reported nausea VAS (0-10) and number of vomiting/retching episodes, categorized as: none (no nausea/vomiting), mild (VAS 1-3 or 1 episode), moderate (VAS 4-6 or 2-3 episodes), severe (VAS ≥ 7 or ≥ 4 episodes or requiring rescue antiemetic) | From Post-Anesthesia Care Unit admission to 72 hours postoperatively |