Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas
Condition: Liver Cancer; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms; Liver Neoplasms
Intervention: Intravenous Patient-Controlled Analgesia (IVPCA); Thoracic Epidural Analgesia (TEA); Questionnaires; Pain Assessment
Intervention description: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.; Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.; Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.; Hourly post surgery rating level of pain on a scale of 0-10.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver Cancer; Pancreatic Cancer; Thoracic epidural analgesia; TEA; Intravenous patient-controlled analgesia; IVPCA; Pain control; Quality of life; QOL; Surgical resection

Summary:

      The goal of this clinical research study is to learn if there is a difference in patients'
      quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after
      surgery on the liver and/or pancreas. Researchers want to learn which method helps people to
      recover more completely and more quickly after surgery.

      The 2 kinds of pain control are intravenous (IV) pain management and epidural pain
      management.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients undergoing liver and/or pancreatic surgical resection for malignancy at MD
             Anderson Cancer Center.

          2. Patients 18 years of age and older. There will be no upper age restriction.

          3. Patients must sign a study-specific consent form.

          4. Adequate coagulation function within 30 days of surgery: Platelets >/= 100,000/ml;
             international normalized ratio (INR) </= 1.5; activated partial thromboplastin time
             (aPTT) </= 40.

          5. Patients must have no fever or evidence of infection or other coexisting medical
             condition that would preclude epidural placement.

        Exclusion Criteria:

          1. Evidence of severe uncontrolled systemic disease or other comorbidity that precludes
             liver or pancreatic surgery.

          2. History of chronic pain, long-term narcotic use or being considered for chronic pain
             consultation postoperatively.

          3. Anaphylaxis to local anesthetics or narcotics.

          4. Previous or current neurologic disease affecting the lower hemithorax or below.

          5. Major open abdominal/thoracic surgery in the previous 30 days under general
             anesthesia, except for total intravenous anesthesia (TIVA).

          6. Technical contraindications to epidural placement: previous thoracic spinal surgery or
             local skin or soft tissue infection at proposed site for epidural insertion.

          7. Ongoing use or planned peri-operative use of anticoagulants (not including deep vein
             thrombosis (DVT) prophylaxis).

          8. Known bleeding diathesis or coagulopathy.

          9. Educational, psychiatric (untreated or poorly controlled schizophrenia, major
             depression, or bipolar disorder), or communication (language) barrier that would
             preclude accurate assessment of postoperative pain and/or ability to answer
             questionnaires (need to be able to read, comprehend, and answer questions).

         10. Inability to comply with study and/or follow-up procedures.

         11. Patient refusal to participate in randomization.

         12. Pregnant women are excluded from this study; women of childbearing potential (defined
             as those who have not undergone a hysterectomy or who have not been postmenopausal for
             at least 12 consecutive months) must agree to practice adequate contraception and to
             refrain from breast-feeding, as specified in the informed consent.

         13. Patients with obvious unresectable disease prior to signing informed consent.