Intrathecal Opioid Influence on Mirna Expression in Cerebrospinal Fluid of Patients with Chronic Abdominal Pain Secondary to Chronic Pancreatitis
Studying the Effects of Intrathecal Opioids on miRNA in Chronic Pancreatitis
Raheleh Rahimi, MD
Primary Investigator
Brief description of study
Management of chronic abdominal pain in patients with chronic pancreatitis could be challenging. Doing this study should help us understand the mechanisms involved in pain perception and hopefully help us better manage chronic abdominal pain.
Detailed description of study
Patients with chronic abdominal pain secondary to chronic pancreatitis presenting to the IUH Advanced Pain Therapies, who will be undergoing intrathecal catheter and pain pump implant, will be consented to participate.
- Patients who are on oral opioid therapy will be weaned off of pain medications. Patients will be off of oral opioid pain medications for 1 week prior to testing.
- Pain level, quality of life and sleep will be assessed using Visual Analogue Scale (VAS), Pancreatitis Quality of Life Instrument (PANQOLI), Comprehensive Pain Assessment Tool- short form (COMPAT-short form), and Insomnia Severity Index before and after weaning from oral opioid pain medications.
- Patients will provide a urine sample for toxicology to ensure no pain medicine exist in their system.
- Patients who have a successful trial with opioid pain medications, will undergo permanent implantation of intrathecal catheter and pain pump, where CSF sample will be collected for pre- treatment miRNA analysis.
- 3-4 months later, pain, quality of life and sleep will be assessed using the tests mentioned above. At this time point, patients with provide another urine sample to ensure no oral pain medicine is being used. CSF will be collected through a catheter port on the pain pump for analysis of miRNA expression.
Pain Levels and Quality of Life
The following tests will be used to assess pain level and different aspects of quality of life before weaning off pain medications, immediately prior to and 3-4 months after intrathecal pump implantation:
4.1.1 Visual Analogue Scale (VAS)
4.1.2 Pancreatitis Quality of Life Instrument (PANQOLI)
4.1.3 Comprehensive Pain Assessment Tool- short form (COMPAT-short form)
4.1.4 Insomnia Severity Index
miRNA Types and Levels
Cerebrospinal fluid samples will be drawn on pump implantation day after weaning off pain medications (at the time of pump implantation) and again 3-4 months after pump implantation.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic pancreatitis, Abdominal pain
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
• Patients with chronic abdominal pain secondary to chronic pancreatitis presenting to the IUH Advanced Pain Therapies. Diagnosis of “chronic pancreatitis” has to have been made by GI through clinical, labs and imaging diagnostic criteria.
• Patients who will be undergoing intrathecal catheter and pain pump implant.
• Patients who are on oral opioid therapy that will be gradually weaned off of pain medications.
• Patients must be above the age of 18. No maximum age required.
Exclusion Criteria
• Patient below the age of 18
• Patients unable to wean off of pain medications
• Patient with major post-operative complications such as pump pocket infection, meningitis or inability to tolerate intrathecal opioid therapy
• Pregnancy
This study investigates the influence of intrathecal opioids on miRNA expression in the cerebrospinal fluid of patients with chronic abdominal pain due to chronic pancreatitis. Chronic pancreatitis is a condition where the pancreas becomes inflamed over a long period, leading to persistent pain. The purpose of this study is to understand how pain perception is affected by intrathecal opioid treatment, which involves delivering pain medicine directly into the spinal fluid.
Participants will undergo several procedures including weaning off oral opioid medications, providing urine samples for toxicology, and having cerebrospinal fluid (CSF) samples collected. Pain levels, quality of life, and sleep will be measured using various tools such as the Visual Analogue Scale (VAS) and the Pancreatitis Quality of Life Instrument (PANQOLI). miRNA levels in the CSF will be analyzed before and after the implantation of an intrathecal pain pump.
- Who can participate: Participants must be over 18 years old with chronic abdominal pain from chronic pancreatitis. They should be able to wean off oral opioid therapy and undergo an intrathecal catheter and pain pump implant.
- Study details: Participants will be required to stop taking oral opioid medications and provide urine samples to confirm no drugs are present. They will then receive an intrathecal pain pump implant, and cerebrospinal fluid samples will be collected for miRNA analysis.
- Study timelines: The study will last 3-4 months.
