• Pain as verbally reported by the patient on a 0-10 verbal scale [ Designated as safety issue: No ]
  

• Clinical benefit response as measured by change in analgesic consumption (PME), Karnofsky performance status, and quality-of-life scores (EORTC QLQ-C30) [ Designated as safety issue: No ]
  
• Side effects (i.e., nausea, sedation, pruritus, constipation, respiratory depression, and urinary retention) [ Designated as safety issue: Yes ]
  
• Patient survival [ Designated as safety issue: No ]
  
• Safety [ Designated as safety issue: Yes ]
  

OBJECTIVES:

Primary

• To compare the effectiveness of pain control comprising intrathecal opioid delivery versus the standard analgesia-delivery method in patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Secondary

• To assess the difference of a total amount of opioid consumption (parenteral morphine equivalent) between two different opioids-delivery groups at one month of treatment.
• To assess the average of percent change in Karnofsky performance status with respect to the baseline status between two different analgesic-delivery groups at one month of treatment.
• To assess the difference in quality of life between two different opioids-delivery groups at one month of treatment using the EORTC QLQ-C30.
• To assess overall survival of these patients.
• To assess the safety profile of two different analgesic-delivery methods (i.e., adverse event and serious adverse event).

OUTLINE: Patients are stratified according to Karnofsky performance status (60-80% vs > 80%). Patients are randomized to 1 of 2 treatment arms.

• Arm I (standard pain management): Patients are evaluated by the JHH Pain Medicine Integrated Team for pain, for the potential of diagnostic/neurolytic celiac plexus block, and undergo the institution of or modification of or continuation and titration of oral or parenteral analgesics. Patients undergo a limited, problem-oriented physical exam including weight, vital signs, Karnofsky performance status (KPS), assessment of previously abnormal findings or new complaints, pain scores, analgesia consumption, side effects (i.e., sleepiness, nausea, pruritus, and constipation), and quality-of-life score (EORTC QLQ-C30) once every 2 weeks for 3 months and then once a month thereafter. Patients also keep a diary of pain scores and side effects during the trial. Patients may have their treatment titrated as needed to control their pain. Patients who are not adequately pain controlled or develop debilitating side effects from their therapy may be managed by adjuvant analgesics or be allowed to crossover into the treatment arm of the study to provide compassionate care.
• Arm II (intrathecal therapy): Patients undergo implantation of a Medtronic intrathecal pump and catheter system for delivery of morphine sulfate directly into the spinal fluid as well as clonidine and/or bupivacaine hydrochloride as adjuvants at the discretion of the investigating clinician. Following implantation, patients undergo a limited, problem-oriented physical exam including vital signs, KPS, assessment of previously abnormal findings or new complaints, pain scores, analgesia consumption, and quality-of life-score (EORTC QLQ-C30) once every 2 weeks for 3 months and then once a month thereafter. Patients are also evaluated by the Interventional Pain Treatment Team for wound status, presence of symptoms of post-dural puncture headache, signs of infection, or meningitis. Patients are followed by the JHH Pain Medicine Integrated Team for evaluation of pain and for institution of or modification of or continuation and titration of oral or parenteral analgesics.

After completion of study treatment, patients are followed for 1 year.