Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients
Condition: Non Small Cell Lung Cancer; Lung Cancer Stage 1
MeSH terms: Lung Neoplasms
Intervention: Liposomal Bupivacaine; Bupivacaine-Epinephrine
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
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)
Masking description: The participant will not be aware of the drug group. A study statistician will generate the randomization with two arms. Statistician will be blinded and will not be aware of the treatment allocation. Researchers and clinicians will be aware of the allocation and drugs will be dispensed by the hospital pharmacy based on the allocation sequence.
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: clinical trial; bupivacaine-epinephrine; bupivacaine liposome; pain; Morphine equivalent dose; lobectomy; Laproscopic lobectomy; VATS lobectomy; opioid medications

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult at least 18 years of age

          2. Subject needs elective lobectomy for non small cell lung cancer

          3. Willing to comply with all aspects of protocol, including providing information about
             opioid usage for post-surgical pain and signed informed consent

        Exclusion Criteria:

          1. < 18 years of age, > 80 years of age

          2. Inability or unwillingness to consent

          3. Emergency surgery

          4. Previous ipsilateral thoracic surgery

          5. Need for operative pleurectomy or pleurodesis

          6. Chronic Narcotic use

          7. Any narcotic use in the 1 month period prior to screening

          8. Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or
             acetaminophen

          9. Moderate to severe hepatic impairment (ALT or AST) value greater than 3 times the
             upper limit of normal.

         10. Severe renal impairment or end stage renal failure disease (creatinine greater than
             2.0 mg/dl).

         11. History of peptic ulcerative disease

         12. Severe chronic obstructive pulmonary disease (COPD) due to LVRS (lung-volume reduction
             surgery).

         13. Pregnancy

         14. Need for conversion from a Video-Assisted Thoracic Surgery procedure to an open
             thoracotomy

         15. Subjects who are incarcerated

         16. Subject has been treated with an experimental device within 30 days or received an
             experimental agent within the longer of 30 days or five half-lives. Or subject is
             current enrolled in another clinical trial.

         17. Unable to follow protocol directions due to organic brain or psychiatric disease.

         18. History of alcoholism or any other substance abuse, which, in the opinion of the
             investigator, would affect compliance with the protocol.