Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients
Condition: Non Small Cell Lung Cancer; Lung Cancer Stage 1
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess pain management after elective thoracoscopic
      lobectomy. The study will compare two local anesthetics that are given intra-operatively
      during lobectomy to see which one helps in better pain control and to see which one helps
      decrease the need for opioid medications. Participants will receive either Marcaine
      (Bupivacaine-epinephrine 0.25%, 1:200,000) or Exparel (Bupivacaine liposomal (1.3%)) and the
      drug will be chosen in a random fashion. Participants will be followed during the hospital
      stay and for one year thereafter. An visual Scale will be administered to measure pain, and
      opioid drug use will be measured by calculating morphine equivalent dose on each day post
      surgery until discharge and thereafter on 30 day, 6 month and 12 month follow-up visits.
      Participants will be monitored for any drug related toxicity and other co-morbid conditions
      for a period on one year post surgery. Overall cost for the surgery and during in hospital
      stay post surgery will be collected and compared between the two treatment arms.
    

Detailed description: 
      The hypothesis of this study is the possibility of liposomal bupivacaine providing more
      relief with less need of narcotics when compared to standard bupivacaine. To test the
      hypothesis the investigators will compare pain management following local infiltration of
      liposomal bupivacaine (Exparel®) versus standard bupivacaine HCl with epinephrine (Marcaine®)
      after VATS (video-assisted thoracoscopic surgery)-lobectomy. This will be accomplished by
      evaluating total opioid usage and patient reported pain scores.

      Study will be conducted at Southern Illinois University-Medicine Clinics and Memorial Medical
      Center. This is a prospective, randomized, single-blind, active control trial for patients
      undergoing elective lobectomy. Participants will be randomly assigned to receive either
      Liposomal Bupivacaine 1.3% or Bupivacaine-Epinephrine 0.25%, 1:200,000 during surgery. Pain
      management will be monitored via opioid usage and visual pain assessment throughout the
      hospital stay and at postoperative day 30, 6 month and 1 year follow up visits. Study
      population includes patients undergoing elective standard of care lobectomy. Based on the
      power analysis, 150 participants (75 in each randomized group) are required to be enrolled in
      the study. Taking into consideration a potential loss of 50 participants due to withdrawal,
      lost to follow up or other reasons, 200 participants will initially be enrolled and
      randomized to attain 150 participants at the end of study (1-year follow up).

      All patients scheduled for surgical consult with Cardiothoracic Surgery for possible video
      assisted thoracoscopic lobectomy will be screened for initial eligibility criteria. Informed
      consent form will be discussed in detail at the clinic by authorized study personnel with all
      participants who are willing to participate in the study. Participants will be given time to
      review the informed consent with family if so desired. After the participant voluntarily
      agrees to participate and signs the informed consent form, the inclusion/exclusion criteria
      will be reviewed again to ensure continued eligibility. Study data including vitals, physical
      examination, medications, and medical and surgical history will be recorded or obtained from
      the electronic health records. Participants will be randomly assigned to one of two study
      drugs- Liposomal Bupivacaine 1.3% or Bupivacaine-Epinephrine 0.25%, 1:200,000. At the end of
      surgery, study drug will be administered as per the standard FDA guidelines. Study drug will
      be administered by the investigator surgeon or members of surgical team under supervision of
      the investigator surgeon. Dose will be calculated by the surgeon based on the screening
      weight of each randomized participant as is done as the standard of care. Treatment
      compliance will be measured in terms of the subject receiving an injection of either
      Liposomal Bupivacaine 1.3% or Bupivacaine-Epinephrine 0.25%, 1:200,000 from the study
      personnel. No other forms of compliance will be measured. Reasons for any deviation will be
      recorded. Outcomes will be measured during post-operative hospital stay and until 1 year
      after surgery for extended follow up which is the standard protocol with cardiothoracic
      surgery.

      Study coordinators will be responsible for data collection and will ensure that forms are
      completed and signed. Protected Health Information (PHI) will be recorded for tracking the
      participants through the course of the study. Subjects may be assigned an identification
      number for unbiased analysis, and will be linked to PHI separately. Data will be collected on
      data collection forms and subsequently entered into REDCap. Original signed consent forms,
      data collection forms and any relevant source documentation will be maintained for the
      duration of the study in locked file cabinets in the department of Cardiothoracic Surgery,
      Southern Illinois University, Springfield, IL. Electronic data will be stored on a secure
      server accessible via password-protected computer. Only authorized study personnel will have
      access to the study data. After completion of data analysis and final manuscript(s) approval,
      all non-electronic records will be sent to university records management for extended
      storage. Records will be stored for such a period after study completion as dictated by the
      university regulations. Adverse events, serious adverse events, discontinuation of drug
      administration due to adverse events will monitored for both the study drugs and will be
      reported to the Institutional Review Board.
    

Intervention name(s): Liposomal Bupivacaine; Bupivacaine-Epinephrine
Intervention type(s): Drug; Drug
Intervention description(s): Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site; Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Intervention MeSH terms: Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to receive either Exparel or Marcaine during surgery. Based on the randomization they will receive one of the two drugs. Participants are assigned one of the two groups in parallel for the duration of the study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: clinical trial; bupivacaine-epinephrine; bupivacaine liposome; pain; Morphine equivalent dose; lobectomy; Laproscopic lobectomy; VATS lobectomy; opioid medications