Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
NCT Number: NCT04403074
Physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound pain management for patients with chronic pancreatitis.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
Chronic pancreatitis is extremely painful and pain management in patients with chronic pancreatitis is challenging. The etiology of abdominal pain in chronic pancreatitis is considered multifactorial. Current treatments for pain control primarily include narcotic & opioid administration; however, these medications require titration of dosage for optimal pain control and are frequently followed by adverse effects such as constipation, nausea or drug addiction. Currently, the FDA has imposed strict regulations regarding the amount, frequency & length of time patients may receive these medications. With tightly controlled regulations for prescribing narcotics and opioids for chronic pain management, the epidemic of street drug usage and overdose has dramatically increased. Alternatively, celiac plexus block and celiac plexus neurolysis performed under EUS guidance have been employed for pain control for at least 2 decades and deemed safe. Celiac plexus block refers to temporary inhibition of nerves of the celiac plexus, by using a combination of steroid and numbing medications injected into the celiac plexus ganglia. Celiac plexus neurolysis (CPN) refers to a temporary to semi-permanent inhibition of nerves of the celiac plexus ganglia. Injection of alcohol as a neurolytic agent is used in place of the steroid which causes neurolysis of the celiac plexus or ganglia.
This study will focus on collecting data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically for the management of chronic pancreatitis pain. This data will be used for research purposes to determine the clinical impact of EUS-CPN management in chronic pancreatitis pain. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved patient management.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
When CPBs are not effective (less than one month of relief) then a Celiac Plexus Neurolysis may be completed to manage pain associated with Chronic Pancreatitis.
Time frame: Immediately post procedure & weekly up to 24 weeks
Use of pain medication (by using morphine equivalents) for each patient will be tracked weekly for up to 24 weeks post CPN to track pain management/relief for the of patients. There should be a lessening in use of pain medication as time progesses.
Time frame: Immediately post procedure and weekly up to 24 weeks
Compare weekly pain intensity score for pain management/relief of patients.
Time frame: Immediately post procedure and weekly up to 24 weeks
Compare dose of pain medication post procedure & weekly for up to 24 weeks after converting all to morphine equivalents
Contact information is provided by the study sponsor or research team.
Indiana University
Other
Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis, Database Repository
Acronym: CPN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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