Pharmacokinetics of Single-Dose Liposomal Bupivacaine in Surgeon Performed Intercostal Nerve Blocks
Condition: Thoracic
Intervention: Liposomal Bupivacaine
Intervention description: intercostal block
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Post-surgery pain management is critical for ensuring timely patient recovery and minimizing
      complications. Part of the multimodal approach to managing severe acute pain in the days
      following surgeries is the use of nerve blocks. The relatively short-lived effect of commonly
      used local anesthetics recently prompted the development and subsequent approval of a
      liposomal formulation of bupivacaine (Exparel; Pacira Pharmaceuticals, Parsippany, New
      Jersey). It has demonstrated favorable pharmacokinetics compared to bupivacaine
      HCl(hydrochloride), with a slower release into blood stream of up to 96 hours after
      administration, following a single dose wound infiltration at the end of various surgeries.
      Studies using other modes of administration reported similar results.

      Thoracic surgeries pose an exceptional challenge as they are one of the most painful
      surgeries and poor pain-management contributes to reduced quality of life and severely
      delayed recovery. The anesthesiology protocol within the Enhanced Recovery After Surgery
      (ERAS) program at medical centers across the world aim to increase patient comfort after
      surgery while reducing complications and use of opioids. As a common part of this protocol,
      intercostal nerve blocks with liposomal bupivacaine are regularly utilized for reduction of
      post-thoracotomy pain and studies show that it may be just as or more effective than
      bupivacaine HCl for treatment of pain, decreasing hospital stays and reducing the incidence
      of complications.

      Despite its frequent use in the surgical room for nerve blocks, the pharmacokinetics of a
      single dose injection of liposomal bupivacaine at the intercostal nerves has never been
      investigated. The aim of this study is to assess the pharmacokinetics of liposomal
      bupivacaine injected at the intercostal nerves. The results of this small-scale study will
      aid in the development of larger such studies in the future, and may aid in the
      standardization of post-thoracotomy pain management. Specifically, the information gleaned
      from this study will allow for the optimal use of additional local anesthetics, particularly
      those administered intravenously, for the purpose of obtaining maximal pain relief while
      minimizing the occurrence of local anesthetic toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  over 18 years of age

          -  Undergoing thoracotomy

        Exclusion Criteria:

          -  Non-English speaking

          -  Pregnant women (self reported)

          -  Prisoners

          -  Weighing <50 kg

          -  Allergy to local anesthetics

          -  Unable to consent for themselves