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

February 7, 2026 updated by: Wei Mei, Huazhong University of Science and Technology
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid consumption after surgery
Time Frame: 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.
The outcome will be monitored and recorded within 72 hours postoperatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analgesic efficacy after surgery
Time Frame: 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.
The outcome will be monitored and recorded within 72 hours postoperatively
Operative time
Time Frame: Intraoperative
Total duration of surgery from skin incision to skin closure, measured in minutes
Intraoperative
Length of hospital stay
Time Frame: Through study completion, up to 7 days
Duration of hospitalization from admission to discharge, measured in days
Through study completion, up to 7 days
Incidence of Allergic Reactions
Time Frame: 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
From first dose to 3 days postoperatively
Incidence of Nerve Injury
Time Frame: 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
From time of nerve block procedure to 7 days postoperatively
Incidence of Respiratory Depression
Time Frame: 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
within 24 hours postoperatively
Incidence of Local Anesthetic Systemic Toxicity (LAST)
Time Frame: 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
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huazhong University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wei Mei, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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