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

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• 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]

Secondary outcome measures (9)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

China · 3 centers

• Nanjing First Hospital — Nanjing
• Nanjing Gaochun People's Hospital — Nanjing
• The First Affiliated Hospital of Soochow University — Suzhou

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 38696340

Identifiers

NCT: NCT07587203 · KY20260402-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗