Chronic Pain Clinical Trial
Official title:
Percutaneous Radiofrequent Lesioning of the Splanchnic Nerves in Patients With Chronic Pancreatitis
Chronic pancreatitis is a progressive inflammatory disease resulting in slow destruction of
the pancreas. This chronic inflammation can lead to chronic abdominal pain which can last
for many years. Unfortunately, medical management often is of only limited benefit in
treating the pain of chronic pancreatitis.
Management of patients with intractable pain is difficult, often resulting in narcotic
addiction.
Early results in a small group of patients suggest that percutaneous radiofrequent lesioning
of splanchnic nerves has good potential for pain control in a subset of patients with
chronic pancreatitis. Given the simplicity of the procedure, it clearly warrants reappraisal
to identify its current role in pancreatic pain management.
Rationale: Pain control is the most pressing problem in patients with chronic pancreatitis.
Many methods have been advocated to control this pain. Unfortunately, these methods fail to
control the pain in 20-50% of patients. Management of patients with intractable pain is
difficult, often resulting in narcotic addiction. Percutaneous alcoholic block of the celiac
plexus is, because of the risks of paralysis and catastrophic haemorrhage resulting from
injury to major abdominal vasculature, restricted to patients with intractable, severe pain
due to terminal pancreatic cancer. Splanchnic nerve lesioning is a useful alternative to
celiac plexus block in the management of patients with chronic upper abdominal pain. The
predictable relationship of the splanchnic nerves to other structures allows for accurate
needle placement and hence a low risk of damage. Radiofrequent lesioning uses a high
frequency alternating current to heat tissues leading to thermal coagulation. It produces
predictable and accurate lesions.
Objective: To evaluate the feasibility and efficacy of percutaneous radiofrequent lesioning
of splanchnic nerves (PRFLSN) in patients with pain caused by chronic pancreatitis. The
primary goal is to determine if a 50% reduction in pain can be achieved for at least 3
months. Secondary objectives are reduction of medication use and improvement of quality of
life.
Design: Single blind, prerandomized intervention study. Study population: Patients with pain
(NRS>5) caused by chronic pancreatitis, despite optimal medical treatment.
Intervention: One group receives PRFLSN after a positive trial block with bupivacaine, the
other group receives no extra treatment besides optimal medical treatment.
Main study endpoints: The percentage of reduction of pain after PRFLSN for a period of at
least 3 months and preferably one year.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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