Arthroscopic Shoulder Surgery, Axillary Nerve Block, Bupivacaine, Suprascapular Nerve Block, Ultrasound Guided Nerve Block
Conditions
Keywords
Arthroscopic Shoulder Surgery, ultrasound guided nerve block, suprascapular nerve block, Axillary Nerve Block
Brief summary
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.
Detailed description
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.
Interventions
DRUGGroup A（ liposomal bupivacene）
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).
DRUGGroup B（bupivacene）
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.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-60 years 2. ASA physical status I-II 3. Undergoing unilateral arthroscopic shoulder surgery 4. The Operative time between 1and 4 hours
Exclusion criteria
1. Anticipated operative time \< 1 h or \> 4 h 2. Severe cardiopulmonary insufficiency 3. Hepatic or renal dysfunction 4. Coagulopathy 5. Diabetic peripheral neuropathy 6. History of nerve injury on the operative side 7. Skin infection at the block site 8. Allergy to amide local anesthetics 9. Refusal to participate or any other condition deemed unsuitable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption after surgery | The outcome will be monitored and recorded within 72 hours postoperatively. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic efficacy after surgery | The outcome will be monitored and recorded within 72 hours postoperatively | 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. |
| Operative time | Intraoperative | Total duration of surgery from skin incision to skin closure, measured in minutes |
| Length of hospital stay | Through study completion, up to 7 days | Duration of hospitalization from admission to discharge, measured in days |
| Incidence of Allergic Reactions | From first dose to 3 days postoperatively | Mild allergic reactions including skin rash, pruritus, urticaria, or local injection site reactions, graded using CTCAE v5.0 criteria |
| Incidence of Nerve Injury | From time of nerve block procedure to 7 days postoperatively | 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 |
| Incidence of Respiratory Depression | within 24 hours postoperatively | 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 |
| Incidence of Local Anesthetic Systemic Toxicity (LAST) | From time of nerve block injection to 6 hours post-procedure | 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 |
| Incidence and Severity of Postoperative Nausea and Vomiting (PONV) | From Post-Anesthesia Care Unit admission to 72 hours postoperatively | 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) |
Contacts
CONTACTWei Xia
PRINCIPAL_INVESTIGATORWei Mei
Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed