Pain and Diaphragmatic Dysfunction After Shoulder ArthroscopyNCT07792044
Effect of Optimal Biological Volume Bupivacaine Liposome Interscalene Brachial Plexus Block on Postoperative Analgesia After Shoulder Arthroscopy
A study testing OBV bupivacaine liposome group and Standard dose bupivacaine liposome group in people with Pain and Diaphragmatic Dysfunction After Shoulder Arthroscopy, run by Affiliated Hospital of Jiaxing University at 1 site in China.
Trial summary
This study aims to evaluate whether 15ml/75mg low-dose bupivacaine liposome is non-inferior to 15ml/133mg standard-dose bupivacaine liposome for postoperative analgesia in interscalene brachial plexus block during arthroscopic shoulder surgery, through a single-center, prospective, double-blind, non-inferiority… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain and Diaphragmatic Dysfunction After Shoulder Arthroscopy
- What is being tested?
- OBV bupivacaine liposome group and Standard dose bupivacaine liposome group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged 18 years or older.
- ASA classification I-III.
- Arthroscopic shoulder rotator cuff repair, capsular plication, acromioplasty, synovectomy, etc.
Who cannot join
- Have a history of lung disease.
- Coagulation dysfunction or coagulopathy.
- History of allergy to local anesthetics.
- infection or lesions at the block site; or history of cervical spine disease.
- 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
- Previous 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 study aims to evaluate whether 15ml/75mg low-dose bupivacaine liposome is non-inferior to 15ml/133mg standard-dose bupivacaine liposome for postoperative analgesia in interscalene brachial plexus block during arthroscopic shoulder surgery, through a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial. It will also assess whether 15ml/75mg low-dose bupivacaine liposome is superior to 15ml/133mg standard-dose bupivacaine liposome in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions during interscalene brachial plexus block.
Read the detailed description
This study is designed as a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial, to evaluate and compare whether the postoperative analgesic efficacy of 15 mL/75 mg low-dose liposomal bupivacaine for interscalene brachial plexus block in patients undergoing shoulder arthroscopy is non-inferior to that of 15 mL/133 mg standard-dose liposomal bupivacaine, and to further assess whether the low-dose regimen demonstrates advantages over the standard-dose counterpart in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions.
- Being tested
- OBV bupivacaine liposome group, Standard dose bupivacaine liposome group
- Keywords
- shoulder arthroscopy, diaphragmatic dysfunction, respiratory function, liposomal bupivacaine
- Medical subject headings
- Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBV bupivacaine liposome groupDrug
Following our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg. This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision.
Standard dose bupivacaine liposome groupDrug
Following the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene
| Study group | Role | What they receive |
|---|---|---|
| OBV bupivacaine liposome group | Experimental | Following our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg. This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision. Receives: Drug: OBV bupivacaine liposome group |
| Standard dose bupivacaine liposome group | Experimental | Following the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene brachial plexus block prior to surgical incision. Receives: Drug: Standard dose bupivacaine liposome group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in numeric rating scale scores for resting pain at 24 hours after surgery
Difference in numeric rating scale scores(0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) for resting pain at 24 hours after surgery. Postoperatively, the NRS scale was used to evaluate pain scores.
Measured: postoperative 24 hours
Secondary outcomes (7)
Total consumption of morphine milligram equivalents within 72 hours postoperatively
Record opioid analgesics within 72 hours postoperatively, convert to morphine equivalent dose, and calculate the total amount.
Measured: within 72 hours postoperatively
Differences in numeric rating scale pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
Differences in numeric rating scale (0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively. Postoperatively, the NRS scoring scale was used to assess pain scores.
Measured: postoperative 0.5 hours, 6 hours, 24 hours, 48 hours, 72 hours
Complete unilateral HDP during quiet breathing at 0.5 hours 6 hours, and 24 hours after completion of block
A diaphragm excursion of >75% on the blocked side measured under ultrasound is defined as complete unilateral hemidiaphragmatic paralysis (HDP).
Measured: postoperative 0.5 hours, 6 hours and 24 hours
Pulmonary function
Use a portable respiratory function tester for bedside testing; have the patient blow three times and take the average.
Measured: postoperative 0.5 hours, 6 hours and 24 hours
All adverse events related to surgery and anesthesia occurring within 72 hours postoperatively
Adverse events associated with nerve blocks within 72 hours postoperatively, including pneumothorax, intravascular injection, local anesthetic toxicity, and Horner syndrome, were recorded.
Measured: within 72 hours postoperatively
The number of rescue analgesic interventions required within 72 hours postoperatively
The number of analgesic administrations within the first 72 hours postoperatively was recorded.
Measured: within 72 hours postoperatively
sensorimotor score
After completion of the block, the simplified sensorimotor assessment scale (3-point method) is used for evaluation, and a total sensorimotor score ≥12 points with a total sensory score ≥3 points is defined as successful brachial plexus block.
Measured: postoperative 0.5 hours, 6 hours and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain and Diaphragmatic Dysfunction After 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792044
- Sponsor's protocol ID
- 2026-LP-402
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Optimal Biological Volume Bupivacaine Liposome Interscalene Brachial Plexus Block on Postoperative Analgesia After Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT07792044
- Acronym / sponsor ID
- 2026-LP-402
- Keywords
- shoulder arthroscopy, diaphragmatic dysfunction, respiratory function, liposomal bupivacaine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 28 Aug 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 study aims to evaluate whether 15ml/75mg low-dose bupivacaine liposome is non-inferior to 15ml/133mg standard-dose bupivacaine liposome for postoperative analgesia in interscalene brachial plexus block during arthroscopic shoulder surgery, through a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial. It will also assess whether 15ml/75mg low-dose bupivacaine liposome is superior to 15ml/133mg standard-dose bupivacaine liposome in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions during interscalene brachial plexus block.
Detailed description
This study is designed as a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial, to evaluate and compare whether the postoperative analgesic efficacy of 15 mL/75 mg low-dose liposomal bupivacaine for interscalene brachial plexus block in patients undergoing shoulder arthroscopy is non-inferior to that of 15 mL/133 mg standard-dose liposomal bupivacaine, and to further assess whether the low-dose regimen demonstrates advantages over the standard-dose counterpart in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OBV bupivacaine liposome group | Experimental | Drug: OBV bupivacaine liposome groupFollowing our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg. This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision. |
| Standard dose bupivacaine liposome group | Experimental | Drug: Standard dose bupivacaine liposome groupFollowing the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene brachial plexus block prior to surgical incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older.
- ASA classification I-III.
- Arthroscopic shoulder rotator cuff repair, capsular plication, acromioplasty, synovectomy, etc.
Key exclusion criteria (9 listed)
- Have a history of lung disease.
- Coagulation dysfunction or coagulopathy.
- History of allergy to local anesthetics.
- infection or lesions at the block site; or history of cervical spine disease.
- 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 |
|---|---|---|
| OBV bupivacaine liposome groupFollowing our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg. This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision. | Drug | OBV bupivacaine liposome group |
| Standard dose bupivacaine liposome groupFollowing the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene | Drug | Standard dose bupivacaine liposome group |
Primary outcome
Difference in numeric rating scale scores for resting pain at 24 hours after surgery
Time frame: postoperative 24 hours
Difference in numeric rating scale scores(0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) for resting pain at 24 hours after surgery. Postoperatively, the NRS scale was used to evaluate pain scores.
7 secondary outcomes
Total consumption of morphine milligram equivalents within 72 hours postoperatively
Time frame: within 72 hours postoperatively
Differences in numeric rating scale pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
Time frame: postoperative 0.5 hours, 6 hours, 24 hours, 48 hours, 72 hours
Complete unilateral HDP during quiet breathing at 0.5 hours 6 hours, and 24 hours after completion of block
Time frame: postoperative 0.5 hours, 6 hours and 24 hours
Pulmonary function
Time frame: postoperative 0.5 hours, 6 hours and 24 hours
All adverse events related to surgery and anesthesia occurring within 72 hours postoperatively
Time frame: within 72 hours postoperatively
The number of rescue analgesic interventions required within 72 hours postoperatively
Time frame: within 72 hours postoperatively
sensorimotor score
Time frame: postoperative 0.5 hours, 6 hours and 24 hours
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 28 Aug 2026.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OBV bupivacaine liposome group and Standard dose bupivacaine liposome group in people with Pain and Diaphragmatic Dysfunction After 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 28 Aug 2026. 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?
Difference in numeric rating scale scores for resting pain at 24 hours after surgery (time frame: postoperative 24 hours). 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 28 Aug 2026.