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Not yet recruiting NCT07410182

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

Phase IV Interventional Arthroscopic Shoulder Surgery Ultrasound Guided Nerve Block Bupivacaine Suprascapular Nerve Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group A（ liposomal bupivacene）, Group B（bupivacene）.
Who it may be relevant to
Registry conditions: Arthroscopic Shoulder Surgery, Ultrasound Guided Nerve Block, Bupivacaine, Suprascapular Nerve Block. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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).
  • 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.

Primary outcome measures

  • Opioid consumption after surgery [Time frame: The outcome will be monitored and recorded within 72 hours postoperatively.]
Secondary outcome measures (8)
  • Analgesic efficacy after surgery [Time frame: The outcome will be monitored and recorded within 72 hours postoperatively]
  • Operative time [Time frame: Intraoperative]
  • Length of hospital stay [Time frame: Through study completion, up to 7 days]
  • Incidence of Allergic Reactions [Time frame: From first dose to 3 days postoperatively]
  • Incidence of Nerve Injury [Time frame: From time of nerve block procedure to 7 days postoperatively]
  • Incidence of Respiratory Depression [Time frame: within 24 hours postoperatively]
  • Incidence of Local Anesthetic Systemic Toxicity (LAST) [Time frame: From time of nerve block injection to 6 hours post-procedure]
  • Incidence and Severity of Postoperative Nausea and Vomiting (PONV) [Time frame: From Post-Anesthesia Care Unit admission to 72 hours postoperatively]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07410182 · TJ-IRB202409035

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗