Four Quadrants Transverse Abdominus Plane (4Q-TAP) Block With Plain and Liposomal Bupivacaine vs. Thoracic Epidermal Analgesia (TEA) in Patients Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) on an Enhanced Recovery Pathway
Condition: Peritoneal Cancer
MeSH terms: Hyperthermia; Fever
Intervention: Local Anesthetic Solution; Bupivacaine HCl; Liposomal Bupivacaine
Intervention description: A bolus or infusion of local anesthetic solution with or without the addition opioids given before surgical incision according to anesthesia provider's clinical judgment.; 30 mg of Bupivacaine HCl in 10 cc of preservative free normal saline (PFNS) injected before surgical incision in each of the four quadrants.; 65 mg of Liposomal Bupivacaine in 10 cc of PFNS injected before surgical incision in each of the four quadrants.
Intervention MeSH terms: Bupivacaine; Anesthetics, Local; Anesthetics
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Local Anesthetic Solution; Bupivacaine HCl; Liposomal Bupivacaine; Peritoneal Cancer

Summary:

      The goal of this clinical research study is to compare the effects of 4 quadrant TAP block
      (4Q-TAP block) with the standard-of-care thoracic epidural analgesia (TEA) in patients
      recovering from cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
      (CRS-HIPEC).

      A 4Q-TAP block is also known as an abdominal wall block and TEA is also known as a thoracic
      epidural. Both are types of anesthetics but are given in different ways. A 4Q-TAP block is
      when anesthetic injections are given in 4 different parts of the abdomen. A TEA is when an
      anesthetic injection is given in the space surrounding the spinal cord through your back.

      This is an investigational study. The surgery and the levels of anesthetic participant is
      receiving are standard-of-care. It is investigational to compare 4Q-TAP block with TEA.

      Up to 140 participants will be enrolled in this study. All will take part at MD Anderson.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written Informed consent

          2. 18 years old or older

          3. American Society of Anesthesiologists physical status (ASA) 1-3

          4. Scheduled surgery: open elective CRS-HIPEC

          5. Able to complete the QoR 15 questionnaire

          6. Patients scheduled to receive intraoperative chemotherapy

        Exclusion Criteria:

          1. Thrombocytopenia (platelet count: <100,000 cell/dL), coagulopathy (International
             Normalized Ratio > 1.5, PT>16.5 seconds or aPTT > 35.9 seconds)

          2. Bupivacaine or liposomal bupivacaine sensitive or known allergy;

          3. Pregnancy or breastfeeding patients

          4. Patients with recent (within 60 days preoperatively) history severe hepatic disease
             (defined as liver injury with encephalopathy plus impaired synthetic liver function
             (i.e. >1.5)

          5. Patients with recent (within 15 days preoperatively) history deteriorate kidney
             function (creatinine serum concentrations > 2.5 mg/dL or eGFR < 30 mL/kg/min)

          6. Chronic opioid use defined as daily opioid use for more than one month prior the
             scheduled date of surgery