Endoscopic Ultrasound-guided Celiac Plexus Neurolysis in the Management of Pain in Abdominal Non-pancreatic Malignancies
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|ClinicalTrials.gov Identifier: NCT01166529|
Recruitment Status : Withdrawn (Unable to identify appropriate patients.)
First Posted : July 21, 2010
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pain Cancer||Procedure: EUS-guided Celiac Plexus Neurolysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Endoscopic Ultrasound (EUS)-Guided Celiac Plexus Neurolysis (CPN) in the Management of Pain in Abdominal Non-pancreatic Malignancies|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Procedure: EUS-guided Celiac Plexus Neurolysis
All patients will receive anesthesia. The linear echo-endoscope will be advanced into the proximal stomach. It will be noted whether the tumor is seen in the celiac axis, if there is flow in the celiac artery, and if the celiac ganglia are seen. The celiac ganglia will be injected directly with 10cc of 0.25% bupivicaine followed by 10cc of 98% dehydrated alcohol. If the celiac ganglia cannot be identified, the posterior and anterior aspects of celiac artery take-off will be injected in a similar manner (twice the volume). Flow in the celiac axis will be confirmed. All injections will be performed with a standard EUS injection needle made especially for CPN . Prior to injection, aspiration will be performed through the needle to ensure that no blood is aspirated.
- Difference between the mean pain score prior to and 1 month after the procedure, as determined by the Brief Pain Inventory (BPI) [ Time Frame: 1 month ]The BPI will be filled out just prior to and 1 month after the procedure to assess the difference in the mean pain score after the procedure
- Difference in mean pain scores before and at 1 day after the procedure, 7 days after the procedure, 14 days after the procedure, and at 2 months after the procedure, as determined by the Brief Pain Inventory (BPI). [ Time Frame: 2 months ]The BPI will be filled out just prior to the procedure and after the procedure at the above intervals (up to 2 months) to assess the difference in the mean pain scores after the procedure.
- Difference in the mean 'level of interference of pain with daily life' score, as determined by the Brief Pain Inventory (BPI). This score will be determined before and after the procedure, determined at the same intervals as mean pain scores. [ Time Frame: 2 months ]
- Narcotic use over a 24-hour period will be documented each time the Brief Pain Inventory (BPI) is completed [ Time Frame: 2 months ]Names, doses, and quantity of pain medications will be reported and converted to an equianalgesic dose (mg/day) of orally administered morphine. The difference in equianalgesic doses (mg/day) will be determined at the same intervals as mean pain scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166529
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Raj N Keswani, MD||Northwestern University|