Intercostal Nerve Block With Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy
Condition: Posterolateral Thoracotomy; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: EXPAREL 266 mg; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: liposome bupivacaine; posterolateral thoracotomy; intercostal nerve block; postoperative pain

Summary:

      The purpose of the study is to examine the safety and efficacy of liposome bupivacaine for
      intercostal nerve block in subjects undergoing posterolateral thoracotomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ≥18 years of age.

          -  Scheduled to undergo a thoracotomy of at least 3 inches (7.6 cm) of intercostal
             incisional length or requiring insertion of an inter-rib spreader/retractor for a
             primary thoracic non-infectious indication under general anesthesia.

          -  American Society of Anesthesiologists (ASA) Physical Status 1 - 3.

          -  Able to provide informed consent, adhere to the study visit schedule, and complete all
             study assessments.

          -  Able to demonstrate sensory function by exhibiting sensitivity to cold in one
             dermatome area in which study drug will be administered.

        Exclusion Criteria:

          -  Currently pregnant, nursing, or planning to become pregnant during the study or within
             1 month after study drug administration. Female subjects must be surgically sterile,
             at least 2 years menopausal, or using an acceptable method of birth control. If of
             childbearing potential, must have a documented negative pregnancy test within 24 hours
             before surgery.

          -  Any planned pleurodesis as part of the surgical procedure.

          -  Use of any of the following medications within the times specified before surgery:
             long-acting opioid medication, non-steroidal anti-inflammatory drug (NSAID), or
             aspirin (except for low-dose aspirin used for cardioprotection or
             acetaminophen/paracetamol) within 3 days and any opioid medication within 24 hours.

          -  Use of selective serotonin reuptake inhibitors (SSRIs), gabapentin, pregabalin
             (Lyrica®), or duloxetine (Cymbalta®) within 3 days of surgery.

          -  Concurrent painful physical condition or concurrent surgery that may require analgesic
             treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not
             strictly related to the surgery, and which may confound the postsurgical assessments
             (e.g., cancer pain, chronic neuropathic pain, concurrent abdominal surgery).

          -  Current use of systemic glucocorticosteroids within 1 month of enrollment.

          -  Body weight < 50 kilograms (110 pounds) or a body mass index ≥ 35 kg/m2.

          -  Contraindication to any of the pain-control agents planned for surgical or
             postsurgical use (i.e., fentanyl, morphine, hydromorphone, oxycodone, or bupivacaine).

          -  Administration of an investigational drug within 30 days or 5 elimination half-lives
             of such investigational drug, whichever is longer, prior to study drug administration,
             or planned administration of another investigational product or procedure during the
             subject's participation in this study.

          -  Previous participation in a liposome bupivacaine study.

          -  History of, suspected, or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years.

          -  Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the Investigator, could interfere with study assessments or compliance.

          -  Current or historical evidence of any clinically significant disease or condition,
             especially cardiovascular or neurological conditions that, in the opinion of the
             Investigator, may increase the risk of surgery or complicate the subject's
             postsurgical course or interfere with the determination of pain intensity related
             solely to the surgery.

          -  Significant medical conditions (including widely disseminated metastatic disease) or
             laboratory results that, in the opinion of the Investigator, indicate an increased
             vulnerability to study drugs and procedures.

          -  Subjects who are planned to receive Entereg® (alvimopan).

          -  Subjects who will receive prophylactic antiemetics or planned postsurgical antiemetics
             given without regard to the subject's emesis needs.