Intraductal Liposomal Bupivacaine for Chronic Pancreatitis
Intraductal Liposomal Bupivacaine for Chronic Pancreatitis
The major clinical features of chronic pancreatitis include glandular (exocrine and
 endocrine) failure and pain. Pain has remained a major clinical challenge and is present in
 up to 90% of patients and is the primary cause of hospitalization in most patients.
 Unfortunately, pain in chronic pancreatitis has been very difficult to treat.

 The investigators hypothesize that the best method to reliably abolish peripheral nerve
 signaling is the use of a local anesthetic within the target organ (i.e. pancreas). This can
 best be done during endoscopic retrograde cholangiopancreatography (ERCP).

 Since ERCP is done under deep sedation or general anesthesia, it is critical to select a
 local anesthetic whose effect persists well after recovery from the procedure; if not, the
 assessment of the effect of the local anesthetic on pain will be impossible to assess. The
 investigators have therefore chosen liposomal bupivacaine (Exparel, Pacira Pharmaceuticals),
 which is an FDA approved product for local infiltration that has a longer duration of action
 (up to 72 hours) and a slower absorption into the systemic circulation, avoiding high plasma
 concentrations.
The major clinical features of chronic pancreatitis include glandular (exocrine and
 endocrine) failure and pain. The former can usually be managed satisfactorily by replacement
 strategies (enzymes or insulin) to restore nutritional and metabolic stability. However, pain
 has remained a major clinical challenge and is present in up to 90% of patients and is the
 primary cause of hospitalization in most patients. Unfortunately, pain in chronic
 pancreatitis has been very difficult to treat, and the investigators' lack of understanding
 about the underlying biology has led to various empirical approaches that are often based on
 purely anatomical grounds, and are generally highly invasive. Significant tissue injury such
 as that observed in chronic pancreatitis not only triggers nociceptor activation but over
 time, can also increase the pain in the whole system, a process called sensitization.

 Determination of the contribution of peripheral versus central factors to nociceptive
 sensitization has significant clinical implications in an individual patient. Thus, if pain
 is caused primarily by signals emanating in the peripheral nerves, then perhaps invasive
 procedures directed against the pancreas (including pancreatectomy) are justified and can be
 expected to have a high probability of success. On the other hand, if central sensitization
 is the dominant pathophysiological factor, then these procedures may cause more harm than
 good and the patient may be best served using aggressive neuromodulator therapies.

 The most direct way to address this question is to interrupt peripheral nerve signaling and
 determine how much of the pain, if any, is taken away. Unfortunately, there are no
 satisfactory methods to do this currently. Although celiac or splanchnic nerve blocks have
 been used for the treatment of pain in chronic pancreatitis, the treatments have had limited
 success for a variety of reasons, including the fact that the technique may not always be
 accurate in terms of the site of injection.

 The investigators hypothesize that the best method to reliably abolish peripheral nerve
 signaling is the use of a local anesthetic within the target organ (i.e. pancreas). This can
 best be done during endoscopic retrograde cholangiopancreatography (ERCP), a technique in
 which the main pancreatic duct is cannulated with the help of a duodenoscope and contrast
 material injected. This technique is routinely done to assess pancreatic duct anatomy prior
 to consideration of a therapeutic intervention such as a stent, stricture dilation, or stone
 removal/lithotripsy.

 Since ERCP is done under deep sedation or general anesthesia, it is critical to select a
 local anesthetic whose effect persists well after recovery from the procedure; if not, the
 assessment of the effect of the local anesthetic on pain will be impossible to assess. The
 investigators have therefore chosen liposomal bupivacaine (Exparel, Pacira Pharmaceuticals),
 which is an FDA approved product for local infiltration that has a longer duration of action
 (up to 72 hours) and a slower absorption into the systemic circulation, avoiding high plasma
 concentrations.
Inclusion Criteria:

 -  Signed Informed consent

 -  Age >18 years

 -  Patients with an established diagnosis of chronic pancreatitis with constant daily
 pain consistent with the same and not relieved despite standard clinical care for at
 least 6 months and in whom ERCP is indicated for standard of care.

 Exclusion Criteria:

 -  Significant liver or renal dysfunction.

 -  Any Contraindication of ERCP.