Bupivacaine Liposome Versus Bupivacaine for Ultrasound-Guided Suprascapular Nerve Combined With Axillary Nerve Block in Analgesia After Arthroscopic Shoulder Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arthroscopic Shoulder Surgery; Suprascapular Nerve Block; Bupivacaine; Ultrasound Guided Nerve Block; Axillary Nerve Block
• Intervention / Treatment: Drug: Group A（ liposomal bupivacene）; Drug: Group B（bupivacene）

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wei Xia; Phone Number: +8615623068980; Email: jamesxia@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 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).	Drug: Group 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).
Active Comparator: Group 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.	Drug: Group 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Wei Mei, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Arthroscopic Shoulder Surgery; ultrasound guided nerve block; suprascapular nerve block; Axillary Nerve Block
• Other Study ID Numbers: TJ-IRB202409035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No