Arthroscopic Shoulder SurgeryPhase 4NCT07410182
Bupivacaine Liposome Versus Bupivacaine for Ultrasound-Guided Suprascapular Nerve Combined With Axillary Nerve Block in Analgesia After Arthroscopic Shoulder Surgery
A Phase 4 study testing Group A（ liposomal bupivacene） and Group B（bupivacene） in people with Arthroscopic Shoulder Surgery and Ultrasound Guided Nerve Block, run by Huazhong University of Science and Technology.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Arthroscopic Shoulder Surgery, Ultrasound Guided Nerve Block, Bupivacaine
- What is being tested?
- Group A（ liposomal bupivacene） and Group B（bupivacene）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60 years
- ASA physical status I-II
- Undergoing unilateral arthroscopic shoulder surgery
- The Operative time between 1and 4 hours
Who cannot join
- 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
Show all 9Show fewer
- Skin infection at the block site
- Allergy to amide local anesthetics
- Refusal to participate or any other condition deemed unsuitable.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Arthroscopic Shoulder Surgery, Ultrasound Guided Nerve Block, Bupivacaine, Suprascapular Nerve Block, Axillary Nerve Block
- Being tested
- Group A（ liposomal bupivacene）, Group B（bupivacene）
- Keywords
- Arthroscopic Shoulder Surgery, ultrasound guided nerve block, suprascapular nerve block, Axillary Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Group B（bupivacene） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The outcome will be monitored and recorded within 72 hours postoperatively.
Secondary outcomes (8)
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.
Measured: 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
Measured: Intraoperative
Length of hospital stay
Duration of hospitalization from admission to discharge, measured in days
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: From Post-Anesthesia Care Unit admission to 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Wei Mei, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410182
- Sponsor's protocol ID
- TJ-IRB202409035
- Status last verified
- Feb 2026
- First submitted
- 29 Dec 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine Liposome Versus Bupivacaine for Ultrasound-Guided Suprascapular Nerve Combined With Axillary Nerve Block in Analgesia After Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT07410182
- Acronym / sponsor ID
- TJ-IRB202409035
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (liposomal bupivacene） | Experimental | 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). |
| Group B（bupivacene） | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-60 years
- ASA physical status I-II
- Undergoing unilateral arthroscopic shoulder surgery
- The Operative time between 1and 4 hours
Key exclusion criteria (9 listed)
- Anticipated operative time < 1 h or > 4 h
- Severe cardiopulmonary insufficiency
- Hepatic or renal dysfunction
- Coagulopathy
- Diabetic peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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） |
| 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） |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Mei principal investigator
Tongji Medical College, Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group A（ liposomal bupivacene） and Group B（bupivacene） in people with Arthroscopic Shoulder Surgery and Ultrasound Guided Nerve Block, run by Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia (+8615623068980, jamesxia@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption after surgery (time frame: The outcome will be monitored and recorded within 72 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.