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

NCT07587203 | Enrolling By Invitation DMC

• 1 other identifier: KY20260402-03
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Rotator Cuff Surgery; Shoulder Arthroscopy; Proximal Humerus Surgery; Shoulder Arthroplasty

Keywords

Liposomal Bupivacaine; Bupivacaine Hydrochloride; Superior Trunk Block of the Interscalene Brachial Plexus; Diaphragmatic Function; Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative hemidiaphragmatic 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.

  Before block and when the patient is awake after surgery

Secondary Outcomes (8)

• Numeric Rating Scale (NRS) scores during activity and at rest

  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)

  Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)

• Postoperative recovery quality (QoR-15 score)

  Postoperative days 1, 2, and 3

• Analgesia satisfaction (OBAS score)

  Postoperative days 1, 2, and 3

• Morphine equivalent consumption

  Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

When performing a superior trunk block of the interscalene brachial plexus, the local anesthetic used is 1.33% liposomal bupivacaine.

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.

Drug: Bupivacaine Hydrochloride

Interventions

Liposomal bupivacaine DRUG

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.

Liposomal Bupivacaine

Bupivacaine Hydrochloride DRUG

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.

Bupivacaine Hydrochloride

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• kg/m² ≤ BMI ≤ 30 kg/m².

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (3)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Nanjing Gaochun People's Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Related Publications (6)

• 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.

  PMID: 38050517 RESULT

• 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.

  PMID: 1539813 RESULT

• 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.

  PMID: 11208979 RESULT

• 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.

  PMID: 32280340 RESULT

• 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.

  PMID: 39254541 RESULT

• 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.

  PMID: 38696340 RESULT

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Anesthesia, Pain and Perioperative Medicine

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 14, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)