Shoulder ArthroscopyNCT06972680
Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene Brachial Plexus Block: A Bayesian Phase I/II Trial
An observational study of Shoulder Arthroscopy, run by Affiliated Hospital of Jiaxing University at 1 site in China.
Trial summary
This single-center, prospective, single-arm, Bayesian phase I/II clinical trial evaluates the incidence of HDP following ISB in shoulder arthroscopy and determines the optimal volume of a single injection of liposomal bupivacaine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroscopy
- What is being tested?
- Bupivacaine Liposomes(BL)
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 30 Dec 2027
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective arthroscopic shoulder surgery at Jiaxing University Affiliated Hospital.
Who may be able to join
- Patients aged 18 years and above;
- ASA classification I-III;
- Undergoing arthroscopic rotator cuff repair, capsular tightening, acromioplasty, synovectomy,.
Who cannot join
- History of pulmonary disease;
- Abnormal coagulation function or coagulation disorders;
- History of local anesthetic allergy;
- Infection, lesion, or history of cervical disease at the block site;
- Pregnancy;
- Refusal to participate in the study or inability to communicate;
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- Long-term use of opioids;
- Body mass index >35 kg/m2;
- History of nerve injury, paralysis, or paresis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This single-center, prospective, single-arm, Bayesian phase I/II clinical trial evaluates the incidence of HDP following ISB in shoulder arthroscopy and determines the optimal volume of a single injection of liposomal bupivacaine.
Read the detailed description
Based on the ISB being the optimal nerve block for post-arthroscopic shoulder surgery analgesia and the potent analgesic effect of bupivacaine liposomes, this study aims to explore the optimal volume of a single ISB injection of bupivacaine liposomes in shoulder arthroscopy using the Bayesian Optimal Interval Design, with the goal of achieving the same analgesic effect while minimizing the incidence and duration of HDP to the greatest extent.
- Conditions
- Shoulder Arthroscopy
- Being tested
- Bupivacaine Liposomes(BL)
- Keywords
- Interscalene brachial plexus block, Phrenic nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Liposomes(BL)Drug
Prior to surgery, an interscalene brachial plexus block was performed, injecting the preset volume of 0.5% bupivacaine liposomes according to the Bayesian optimal interval method.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene brachial plexus block | Not described Receives: Drug: Bupivacaine Liposomes(BL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemidiaphragmatic paresis incidence rate(Phase Ⅰ)
The diaphragmatic excursion was measured using ultrasound 0.5 hours after the completion of the nerve block, and partial or complete unilateral Hemidiaphragmatic paresis(HDP) was assessed based on the diaphragmatic excursion. No excursion was defined as ≤25%, partial excursion as >25% and ≤75%, and complete excursion as >75%. A diaphragmatic excursion greater than or equal to 25% measured by ultrasound can be defined as HDP.
Measured: Perioperative
Success rate of interscalene brachial plexus block (Phase II)
Before the surgery, an ultrasound-guided interscalene brachial plexus block is performed. After the surgery, when the patient is fully awake, a simplified sensory-motor assessment scale is used for evaluation. A comprehensive score of ≥12 is defined as a successful nerve block.
Measured: Perioperative
Secondary outcomes (2)
Hemidiaphragmatic paresis incidence rate
The diaphragmatic excursion was measured using ultrasound 6 hours and 24 hours after the completion of the nerve block, and partial or complete unilateral Hemidiaphragmatic paresis(HDP) was assessed based on the diaphragmatic excursion. No excursion was defined as ≤25%, partial excursion as >25% and ≤75%, and complete excursion as >75%. A diaphragmatic excursion greater than or equal to 25% measured by ultrasound can be defined as HDP.
Measured: Perioperative
Lung function
Lung function parameters, including tidal volume, vital capacity, and forced vital capacity, were measured bedside using a portable respiratory function monitor at 0.5 hours, 6 hours, and 24 hours after nerve block.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 May 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-he Zhou, Affiliated Hospital of Jiaxing University
- Investigators
- Mingzi An, MD, Principal investigator, Jiaxing University Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972680
- Sponsor's protocol ID
- 2025-LP-076
- Status last verified
- May 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene Brachial Plexus Block: A Bayesian Phase I/II Trial
- ClinicalTrials.gov ID
- NCT06972680
- Acronym / sponsor ID
- 2025-LP-076
- Conditions
- Shoulder Arthroscopy
- Keywords
- Interscalene brachial plexus block, Phrenic nerve block
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 15 May 2025 (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 single-center, prospective, single-arm, Bayesian phase I/II clinical trial evaluates the incidence of HDP following ISB in shoulder arthroscopy and determines the optimal volume of a single injection of liposomal bupivacaine.
Detailed description
Based on the ISB being the optimal nerve block for post-arthroscopic shoulder surgery analgesia and the potent analgesic effect of bupivacaine liposomes, this study aims to explore the optimal volume of a single ISB injection of bupivacaine liposomes in shoulder arthroscopy using the Bayesian Optimal Interval Design, with the goal of achieving the same analgesic effect while minimizing the incidence and duration of HDP to the greatest extent.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interscalene brachial plexus block | – | Drug: Bupivacaine Liposomes(BL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective arthroscopic shoulder surgery at Jiaxing University Affiliated Hospital.
Key inclusion criteria (3 listed)
- Patients aged 18 years and above;
- ASA classification I-III;
- Undergoing arthroscopic rotator cuff repair, capsular tightening, acromioplasty, synovectomy,.
Key exclusion criteria (9 listed)
- History of pulmonary disease;
- Abnormal coagulation function or coagulation disorders;
- History of local anesthetic allergy;
- Infection, lesion, or history of cervical disease at the block site;
- Pregnancy;
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 |
|---|---|---|
| Bupivacaine Liposomes(BL)Prior to surgery, an interscalene brachial plexus block was performed, injecting the preset volume of 0.5% bupivacaine liposomes according to the Bayesian optimal interval method. | Drug | Interscalene brachial plexus block |
Primary outcome
Hemidiaphragmatic paresis incidence rate(Phase Ⅰ)
Time frame: Perioperative
The diaphragmatic excursion was measured using ultrasound 0.5 hours after the completion of the nerve block, and partial or complete unilateral Hemidiaphragmatic paresis(HDP) was assessed based on the diaphragmatic excursion. No excursion was defined as ≤25%, partial excursion as >25% and ≤75%, and complete excursion as >75%. A diaphragmatic excursion greater than or equal to 25% measured by ultrasound can be defined as HDP.
Success rate of interscalene brachial plexus block (Phase II)
Time frame: Perioperative
Before the surgery, an ultrasound-guided interscalene brachial plexus block is performed. After the surgery, when the patient is fully awake, a simplified sensory-motor assessment scale is used for evaluation. A comprehensive score of ≥12 is defined as a successful nerve block.
2 secondary outcomes
Hemidiaphragmatic paresis incidence rate
Time frame: Perioperative
Lung function
Time frame: Perioperative
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 15 May 2025.
Related trials for Shoulder Arthroscopy
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Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
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Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
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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.
Mingzi An, MD principal investigator
Jiaxing University Affiliated Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthroscopy, run by Affiliated Hospital of Jiaxing University at 1 site in China.
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 3 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: enrolling by invitation, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemidiaphragmatic paresis incidence rate(Phase Ⅰ) (time frame: Perioperative). The study lists 2 primary outcomes in all. 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 15 May 2025.