Proximal Humerus SurgeryNCT07587203

Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia

A study testing Liposomal bupivacaine and Bupivacaine Hydrochloride in people with Proximal Humerus Surgery and Rotator Cuff Surgery, run by Nanjing First Hospital, Nanjing Medical University at 3 sites in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

To compare the effects of 1.33% liposomal bupivacaine versus 0.375% bupivacaine hydrochloride for superior trunk block of the interscalene brachial plexus on postoperative diaphragmatic function and analgesic efficacy in shoulder surgery. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Proximal Humerus Surgery, Rotator Cuff Surgery, Shoulder Arthroplasty
What is being tested?: Liposomal bupivacaine and Bupivacaine Hydrochloride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 3 sitesChina
Study dates: 1 Jun 2026to 31 Dec 2027
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients scheduled for elective unilateral proximal humerus surgery, rotator cuff surgery, shoulder arthroplasty, or shoulder arthroscopy;
Visible diaphragmatic movement on the surgical side under ultrasound before anesthesia;
Patient provides informed consent;
Age 18-80 years, any gender;
ASA physical status I-III;
18 kg/m² ≤ BMI ≤ 30 kg/m².

Who cannot join

Coagulopathy;
Allergy to local anesthetics;
Infection at the puncture site;
History of chronic pain or opioid use;
Severe respiratory disease;
Pregnancy;
Diabetes and peripheral neuropathy;
Inability to understand assessment scales.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China3 sites

Nanjing First Hospital
Nanjing, Jiangsu, 210006
Nanjing Gaochun People's Hospital
Nanjing, Jiangsu
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu

Other trials in China

About this study

Official title: Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia in Shoulder Surgery: A Multicenter, Randomized Controlled Study

Conditions: Proximal Humerus Surgery, Rotator Cuff Surgery, Shoulder Arthroplasty, Shoulder Arthroscopy
Being tested: Liposomal bupivacaine, Bupivacaine Hydrochloride
Keywords: Liposomal Bupivacaine, Bupivacaine Hydrochloride, Superior Trunk Block of the Interscalene Brachial Plexus, Diaphragmatic Function, Shoulder Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Liposomal bupivacaineDrug
The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 1.33% Liposomal bupivacaine 10ml was injected.
Bupivacaine HydrochlorideDrug
The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 0.375% Bupivacaine Hydrochloride 10ml was injected.

Study groups in NCT07587203
Study group	Role	What they receive
Liposomal Bupivacaine	Experimental	When performing a superior trunk block of the interscalene brachial plexus, the local anesthetic used is 1.33% liposomal bupivacaine. Receives: Drug: Liposomal bupivacaine
Bupivacaine Hydrochloride	Active comparator	When performing the superior trunk block of the interscalene brachial plexus, 0.375% bupivacaine hydrochloride is used as the local anesthetic. Receives: Drug: Bupivacaine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
Observe diaphragmatic movement through the hepatic or splenic acoustic window and measure the amplitude of diaphragmatic excursion on the anesthetized side using M-mode (average of 3 waveforms). Diaphragmatic Function Evaluation[4,5]: A decrease in diaphragmatic excursion amplitude during deep breathing of <25% compared to pre-block is defined as normal diaphragmatic movement. A decrease of 25%-75% is defined as partial diaphragmatic paralysis. A decrease of >75% is defined as complete diaphragmatic paralysis.
Measured: Before block and before leaving the PACU after surgery

Secondary outcomes (9)

The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
Observe diaphragmatic movement through the hepatic or splenic acoustic window and measure the amplitude of diaphragmatic excursion on the anesthetized side using M-mode (average of 3 waveforms). Diaphragmatic Function Evaluation[4,5]: A decrease in diaphragmatic excursion amplitude during deep breathing of <25% compared to pre-block is defined as normal diaphragmatic movement. A decrease of 25%-75% is defined as partial diaphragmatic paralysis. A decrease of >75% is defined as complete diaphragmatic paralysis.
Measured: Postoperative 24 hours
Numeric Rating Scale (NRS) scores during activity and at rest
Pain intensity at the surgical site will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable." Patients will self-report their pain intensity at rest (Resting NRS) and during active movement (Dynamic NRS)
Measured: Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
The area under the pain intensity-time curve (PI-AUC)
The Pain Intensity-Area Under the Curve (PI-AUC) will be calculated as a summary measure of overall pain burden over time. The AUC for each patient will be computed for three consecutive postoperative periods based on the serial NRS scores (both resting and dynamic) collected during those intervals. A smaller AUC indicates better overall analgesic control during the specified period.
Measured: Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
Postoperative recovery quality (QoR-15 score)
Patient-reported recovery quality will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire. This validated tool evaluates physical comfort, physical independence, psychological support, emotional state, and pain. Scores range from 0 (extremely poor recovery) to 150 (excellent recovery). The upward trend of the QoR-15 score signifies a progressive and comprehensive improvement in a patient's postoperative recovery experience across physical, emotional, and functional domains.
Measured: Postoperative days 1, 2, and 3
Analgesia satisfaction (OBAS score)
Patient satisfaction with analgesia and its associated side effects will be evaluated using the Overall Benefit of Analgesia Score (OBAS). The OBAS is a composite score (range 0-28, lower is better) incorporating assessments of pain intensity, nausea/vomiting, dizziness, sedation, itching, and patient satisfaction. The downward trend of the OBAS score indicates a progressively more favorable balance between analgesic efficacy and the burden of treatment-related side effects, representing an increasing net benefit of the analgesia regimen.
Measured: Postoperative days 1, 2, and 3
Morphine equivalent consumption
The total consumption of all opioid analgesics administered to the patient (including patient-controlled analgesia and rescue doses). All opioid doses will be converted to intravenous morphine milligram equivalents (MME) using standard conversion ratios for summation and comparison. A lower morphine equivalent consumption indicates better analgesic efficacy and a longer duration of action for liposomal bupivacaine.
Measured: Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
The cumulative dosage of rescue analgesic medication (calculated as morphine equivalent in mg)
This refers specifically to the summed dose of supplemental (rescue) opioid analgesics administered upon patient request for breakthrough pain. The cumulative dose for each period will be calculated and expressed in intravenous morphine milligram equivalents (MME). A lower morphine equivalent consumption indicates better analgesic efficacy and a longer duration of action for liposomal bupivacaine.
Measured: 0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
Incidence of adverse events: Vascular injury, hoarseness, Horner's syndrome, SpO2 below 90% without oxygen supplementation after leaving PACU, dyspnea, numbness of fingers, dyskinesia.
Vascular injury: Evidence of hematoma or vascular puncture during needle placement.
Hoarseness: Patient-reported or clinician-identified voice change suggestive of recurrent laryngeal nerve involvement.
Horner's syndrome: Presence of ptosis, miosis, and/or anhidrosis on the blocked side.
Diaphragmatic paralysis: defined by a reduction in diaphragmatic excursion amplitude >25% from baseline on ultrasound assessment performed post-block.
SpO2 <90% on room air after PACU discharge: Oxygen saturation falling below 90% while breathing room air, occurring after the patient has been discharged from the PACU, and not related to other obvious causes.
Dyspnea: Subjective sensation of shortness of breath or labored breathing. Finger numbness: Persistent numbness or loss of sensation in the fingers of the blocked upper limb.
Motor difficulty: Persistent weakness or inability to perform specific voluntary movements in the blocked upper limb.
Measured: Postoperative 72 hours
Telephone follow-up for pain NRS score
Patients will be contacted by telephone at 3 months after surgery. They will be asked to self-report their current average pain intensity over the past 24 hours at the surgical site using the 11-point Numeric Rating Scale (NRS, 0-10), where 0 represents "no pain" and 10 represents "the worst pain imaginable." This assesses the potential long-term impact of the analgesic intervention on persistent postoperative pain.
Measured: Postoperative 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202631 Dec 2027

First posted14 May 2026
Study start1 Jun 2026
Primary completion31 Mar 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Proximal Humerus SurgeryStudies of the same condition, open and under way.
More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 184 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07587203
Sponsor's protocol ID: KY20260402-03
Status last verified: Jun 2026
First submitted: 5 May 2026
Last updated: 16 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Amaral S, Arsky Lombardi R, Medeiros H, Nogueira A, Gadsden J. Superior Trunk Block Is an Effective Phrenic-Sparing Alternative to Interscalene Block for Shoulder Arthroscopy: A Systematic Review and Meta-Analysis. Cureus. 2023 Nov 3;15(11):e48217. doi: 10.7759/cureus.48217. eCollection 2023 Nov.
PubMed 38050517
Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.
PubMed 1539813
Wilson TA, Legrand A, Gevenois PA, De Troyer A. Respiratory effects of the external and internal intercostal muscles in humans. J Physiol. 2001 Jan 15;530(Pt 2):319-30. doi: 10.1111/j.1469-7793.2001.0319l.x.
PubMed 11208979
Hutchins JL, Habeck J, Novaczyk Z, Campbell R, Creedon C, Spartz E, Richter M, Wolter J, Suryawanshi G, Kaizer A, Berg AA. Patient Complications after Interscalene Block: A Retrospective Comparison of Liposomal Bupivacaine to Nonliposomal Bupivacaine. Anesthesiol Res Pract. 2020 Mar 27;2020:6704303. doi: 10.1155/2020/6704303. eCollection 2020.
PubMed 32280340
Ilfeld BM, Sessler DI. Liposomal Bupivacaine in Peripheral Nerve Blocks: Duration and Meaningful Differences. Anesthesiology. 2024 Oct 1;141(4):638-642. doi: 10.1097/ALN.0000000000005133. No abstract available.
PubMed 39254541
Chan TCW, Wong JSH, Wang F, Fang CX, Yung CS, Chan MTH, Chan WSH, Wong SSC. Addition of Liposomal Bupivacaine to Standard Bupivacaine versus Standard Bupivacaine Alone in the Supraclavicular Brachial Plexus Block: A Randomized Controlled Trial. Anesthesiology. 2024 Oct 1;141(4):732-744. doi: 10.1097/ALN.0000000000005035.
PubMed 38696340

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Proximal Humerus Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia in Shoulder Surgery: A Multicenter, Randomized Controlled Study
ClinicalTrials.gov ID: NCT07587203
Acronym / sponsor ID: KY20260402-03
Conditions: Proximal Humerus Surgery, Rotator Cuff Surgery, Shoulder Arthroplasty, Shoulder Arthroscopy
Keywords: Liposomal Bupivacaine, Bupivacaine Hydrochloride, Superior Trunk Block of the Interscalene Brachial Plexus, Diaphragmatic Function, Shoulder Surgery
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 184 participants (estimated)
Lead sponsor: Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
Study start: 1 Jun 2026 (actual)
Primary completion: 31 Mar 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 14 May 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Liposomal Bupivacaine	Experimental	Drug: Liposomal bupivacaineWhen performing a superior trunk block of the interscalene brachial plexus, the local anesthetic used is 1.33% liposomal bupivacaine.
Bupivacaine Hydrochloride	Active comparator	Drug: Bupivacaine HydrochlorideWhen performing the superior trunk block of the interscalene brachial plexus, 0.375% bupivacaine hydrochloride is used as the local anesthetic.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients scheduled for elective unilateral proximal humerus surgery, rotator cuff surgery, shoulder arthroplasty, or shoulder arthroscopy;
Visible diaphragmatic movement on the surgical side under ultrasound before anesthesia;
Patient provides informed consent;
Age 18-80 years, any gender;
ASA physical status I-III;

Key exclusion criteria (8 listed)

Coagulopathy;
Allergy to local anesthetics;
Infection at the puncture site;
History of chronic pain or opioid use;
Severe respiratory disease;

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
Liposomal bupivacaineThe superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 1.33% Liposomal bupivacaine 10ml was injected.	Drug	Liposomal Bupivacaine
Bupivacaine HydrochlorideThe superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 0.375% Bupivacaine Hydrochloride 10ml was injected.	Drug	Bupivacaine Hydrochloride

Primary outcome

The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
Time frame: Before block and before leaving the PACU after surgery
Observe diaphragmatic movement through the hepatic or splenic acoustic window and measure the amplitude of diaphragmatic excursion on the anesthetized side using M-mode (average of 3 waveforms). Diaphragmatic Function Evaluation[4,5]: A decrease in diaphragmatic excursion amplitude during deep breathing of <25% compared to pre-block is defined as normal diaphragmatic movement. A decrease of 25%-75% is defined as partial diaphragmatic paralysis. A decrease of >75% is defined as complete diaphragmatic paralysis.

9 secondary outcomes

The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
Time frame: Postoperative 24 hours
Numeric Rating Scale (NRS) scores during activity and at rest
Time frame: Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
The area under the pain intensity-time curve (PI-AUC)
Time frame: Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
Postoperative recovery quality (QoR-15 score)
Time frame: Postoperative days 1, 2, and 3
Analgesia satisfaction (OBAS score)
Time frame: Postoperative days 1, 2, and 3
Morphine equivalent consumption
Time frame: Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
The cumulative dosage of rescue analgesic medication (calculated as morphine equivalent in mg)
Time frame: 0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
Incidence of adverse events: Vascular injury, hoarseness, Horner's syndrome, SpO2 below 90% without oxygen supplementation after leaving PACU, dyspnea, numbness of fingers, dyskinesia.
Time frame: Postoperative 72 hours
Telephone follow-up for pain NRS score
Time frame: Postoperative 3 months

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 16 Jun 2026.
Results publication: PubMed 38050517Amaral S, Arsky Lombardi R, Medeiros H, Nogueira A, Gadsden J. Superior Trunk Block Is an Effective Phrenic-Sparing Alternative to Interscalene Block for Shoulder Arthroscopy: A Systematic Review and Meta-Analysis. Cureus. 2023 Nov 3;15(11):e48217. doi: 10.7759/cureus.48217. eCollection 2023 Nov.
Results publication: PubMed 1539813Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.
Results publication: PubMed 11208979Wilson TA, Legrand A, Gevenois PA, De Troyer A. Respiratory effects of the external and internal intercostal muscles in humans. J Physiol. 2001 Jan 15;530(Pt 2):319-30. doi: 10.1111/j.1469-7793.2001.0319l.x.
Results publication: PubMed 32280340Hutchins JL, Habeck J, Novaczyk Z, Campbell R, Creedon C, Spartz E, Richter M, Wolter J, Suryawanshi G, Kaizer A, Berg AA. Patient Complications after Interscalene Block: A Retrospective Comparison of Liposomal Bupivacaine to Nonliposomal Bupivacaine. Anesthesiol Res Pract. 2020 Mar 27;2020:6704303. doi: 10.1155/2020/6704303. eCollection 2020.
Results publication: PubMed 39254541Ilfeld BM, Sessler DI. Liposomal Bupivacaine in Peripheral Nerve Blocks: Duration and Meaningful Differences. Anesthesiology. 2024 Oct 1;141(4):638-642. doi: 10.1097/ALN.0000000000005133. No abstract available.
Results publication: PubMed 38696340Chan TCW, Wong JSH, Wang F, Fang CX, Yung CS, Chan MTH, Chan WSH, Wong SSC. Addition of Liposomal Bupivacaine to Standard Bupivacaine versus Standard Bupivacaine Alone in the Supraclavicular Brachial Plexus Block: A Randomized Controlled Trial. Anesthesiology. 2024 Oct 1;141(4):732-744. doi: 10.1097/ALN.0000000000005035.
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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 8 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus (time frame: Before block and before leaving the PACU after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07587203, which also lists 6 linked publications.

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 16 Jun 2026.