Effect of Optimal Biological Volume Bupivacaine Liposome Interscalene Brachial Plexus Block on Postoperative Analgesia After Shoulder Arthroscopy

NCT07792044 | Enrolling By Invitation DMC

• 1 other identifier: 2026-LP-402
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pain and Diaphragmatic Dysfunction After Shoulder Arthroscopy

Keywords

shoulder arthroscopy; diaphragmatic dysfunction; respiratory function; liposomal bupivacaine

Outcome Measures

Primary Outcomes (1)

• 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.

  postoperative 24 hours

Secondary Outcomes (7)

• Total consumption of morphine milligram equivalents within 72 hours postoperatively

  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

  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

  postoperative 0.5 hours, 6 hours and 24 hours

• Pulmonary function

  postoperative 0.5 hours, 6 hours and 24 hours

• All adverse events related to surgery and anesthesia occurring within 72 hours postoperatively

  within 72 hours postoperatively

Study Arms (2)

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.

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.

Drug: Standard dose bupivacaine liposome group

Interventions

OBV bupivacaine liposome group DRUG

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.

OBV bupivacaine liposome group

Standard dose bupivacaine liposome group DRUG

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

Standard dose bupivacaine liposome group

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years or older.
• ASA classification I-III.
• Arthroscopic shoulder rotator cuff repair, capsular plication, acromioplasty, synovectomy, etc.

You may not qualify if:

• 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.
• Long-term use of opioids.
• Body mass index \>35 kg/m2
• Previous history of nerve injury, paralysis, or paresis;

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

Jiaxing University Affiliated Hospital

Jiaxing, Zhejiang, 314000, China

Location

MeSH Terms

Conditions

Pain; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Anesthesiology

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)