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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Shoulder Arthroplasty; Shoulder Arthroscopy; Proximal Humerus Surgery; Rotator Cuff Surgery
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal Bupivacaine; When performing a superior trunk block of the interscalene brachial plexus, the local anesthetic used is 1.33% liposomal bupivacaine.	Drug: Liposomal bupivacaine; 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.
Active Comparator: Bupivacaine Hydrochloride; When performing the superior trunk block of the interscalene brachial plexus, 0.375% bupivacaine hydrochloride is used as the local anesthetic.	Drug: Bupivacaine Hydrochloride; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before block 、before leaving the PACU after surgery and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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.	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.	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.	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.	0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
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.	Postoperative 3 months
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.	Postoperative 72 hours

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Shoulder Surgery; Liposomal Bupivacaine; Bupivacaine Hydrochloride; Diaphragmatic Function; Superior Trunk Block of the Interscalene Brachial Plexus
• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: KY20260402-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No