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

Condition(s) studied

Investigational drug(s) / intervention(s)

Bupivacaine Liposomes(BL): 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Hemidiaphragmatic paresis incidence rate(Phase Ⅰ) — 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.
• Success rate of interscalene brachial plexus block (Phase II) — 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.

Trial sites (1)

More Affiliated Hospital of Jiaxing University trials in China

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