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Enrolling by Invitation

NCT Number: NCT06972680

Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene Brachial Plexus Block: A Bayesian Phase I/II Trial

This single-center, prospective, single-arm, Bayesian phase I/II clinical trial evaluates the incidence of HDP following ISB in shoulder arthroscopy and determines the optimal volume of a single injection of liposomal bupivacaine.

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Key information

Conditions

Shoulder Arthroscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiaxing University Affiliated Hospital

Jiaxing, Zhejiang, 314000, China

About this study

Based on the ISB being the optimal nerve block for post-arthroscopic shoulder surgery analgesia and the potent analgesic effect of bupivacaine liposomes, this study aims to explore the optimal volume of a single ISB injection of bupivacaine liposomes in shoulder arthroscopy using the Bayesian Optimal Interval Design, with the goal of achieving the same analgesic effect while minimizing the incidence and duration of HDP to the greatest extent.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years and above;
  • ASA classification I-III;
  • Undergoing arthroscopic rotator cuff repair, capsular tightening, acromioplasty, synovectomy,.

Exclusion criteria

  • History of pulmonary disease;
  • Abnormal coagulation function or coagulation disorders;
  • History of local anesthetic allergy;
  • Infection, lesion, or history of cervical disease at the block site;
  • Pregnancy;
  • Refusal to participate in the study or inability to communicate;
  • Long-term use of opioids;
  • Body mass index >35 kg/m2;
  • History of nerve injury, paralysis, or paresis.

Treatment and study plan

Bupivacaine Liposomes(BL)

Drug

Prior to surgery, an interscalene brachial plexus block was performed, injecting the preset volume of 0.5% bupivacaine liposomes according to the Bayesian optimal interval method.

Primary outcomes

  1. Hemidiaphragmatic paresis incidence rate(Phase Ⅰ)

    Time frame: Perioperative

    The diaphragmatic excursion was measured using ultrasound 0.5 hours after the completion of the nerve block, and partial or complete unilateral Hemidiaphragmatic paresis(HDP) was assessed based on the diaphragmatic excursion. No excursion was defined as ≤25%, partial excursion as >25% and ≤75%, and complete excursion as >75%. A diaphragmatic excursion greater than or equal to 25% measured by ultrasound can be defined as HDP.

  2. Success rate of interscalene brachial plexus block (Phase II)

    Time frame: Perioperative

    Before the surgery, an ultrasound-guided interscalene brachial plexus block is performed. After the surgery, when the patient is fully awake, a simplified sensory-motor assessment scale is used for evaluation. A comprehensive score of ≥12 is defined as a successful nerve block.

Secondary outcomes

  1. Hemidiaphragmatic paresis incidence rate

    Time frame: Perioperative

    The diaphragmatic excursion was measured using ultrasound 6 hours and 24 hours after the completion of the nerve block, and partial or complete unilateral Hemidiaphragmatic paresis(HDP) was assessed based on the diaphragmatic excursion. No excursion was defined as ≤25%, partial excursion as >25% and ≤75%, and complete excursion as >75%. A diaphragmatic excursion greater than or equal to 25% measured by ultrasound can be defined as HDP.

  2. Lung function

    Time frame: Perioperative

    Lung function parameters, including tidal volume, vital capacity, and forced vital capacity, were measured bedside using a portable respiratory function monitor at 0.5 hours, 6 hours, and 24 hours after nerve block.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Jiaxing University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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