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

NCT07410182 | Not Yet Recruiting Phase 4

• 1 other identifier: TJ-IRB202409035
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthroscopic Shoulder Surgery; Ultrasound Guided Nerve Block; Bupivacaine; Suprascapular Nerve Block; Axillary Nerve Block

Keywords

Arthroscopic Shoulder Surgery; ultrasound guided nerve block; suprascapular nerve block; Axillary Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Analgesic efficacy after surgery

  The outcome will be monitored and recorded within 72 hours postoperatively

• Operative time

  Intraoperative

• Length of hospital stay

  Through study completion, up to 7 days

• Incidence of Allergic Reactions

  From first dose to 3 days postoperatively

• Incidence of Nerve Injury

  From time of nerve block procedure to 7 days postoperatively

Study Arms (2)

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).

Drug: Group A（ liposomal bupivacene）

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.

Drug: Group B（bupivacene）

Interventions

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).

Group A (liposomal bupivacene）

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.

Group B（bupivacene）

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-60 years
• ASA physical status I-II
• Undergoing unilateral arthroscopic shoulder surgery
• The Operative time between 1and 4 hours

You may not qualify if:

• Anticipated operative time \< 1 h or \> 4 h
• Severe cardiopulmonary insufficiency
• Hepatic or renal dysfunction
• Coagulopathy
• Diabetic peripheral neuropathy
• History of nerve injury on the operative side
• Skin infection at the block site
• Allergy to amide local anesthetics
• Refusal to participate or any other condition deemed unsuitable.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Officials

• Wei Mei

  Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xia

CONTACT

+8615623068980; jamesxia@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share