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A Randomized Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Neurolysis (EUS-CPN) With and Without Bupivacaine

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of absolute alcohol around the base of the celiac plexus (celiac plexus neurolysis (EUS-CPN)), to help alleviate pain associated with pancreatic cancer. It is standard procedure to inject bupivacaine immediately before injecting absolute alcohol, to theoretically prevent pain that may occur during and after the procedure. However, there are no data showing whether bupivacaine injection has any real influence on intra-procedural, immediate post-procedural, or long-term pain control. The injection of bupivacaine before the alcohol may have no effect, a synergistic effect, or an antagonistic effect, by diluting the alcohol, and reducing its neurolytic capacity. Inadvertent intravascular injection of bupivacaine may also cause irreversible cardiac arrhythmias and death. The investigators therefore propose a randomized clinical trial to determine whether the exclusion of bupivacaine during EUS-guided CPN improves outcomes, or not.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Malignant-appearing pancreatic mass, or proven pancreatic cancer involving the pancreatic genu, body, or tail

• Any level of abdominal or back pain considered to be potentially related to the mass:

‣ New onset pain (\<3 months)

⁃ Constant

⁃ Centrally located

⁃ With or without irradiation to the back

⁃ No obvious other source of pain based on history and physical examination by the attending endosonographer

• No possibility of surgical management

• Signed, informed consent

• Celiac axis accessible for bilateral neurolysis at EUS.

Locations
Other Locations
Canada
Centre de recherche du Centre hospitalier de l'Université de Montréal
RECRUITING
Montreal
Contact Information
Primary
CHARLES MACKAY, RN
charles.mackay.chum@ssss.gouv.qc.ca
514-890-8000
Time Frame
Start Date: 2021-10-07
Estimated Completion Date: 2027-12
Participants
Target number of participants: 180
Treatments
Active_comparator: EUS-CPN with bupivacaine
Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL preceded by injection of 10 ml of bupivacaine 0.5%.
Experimental: EUS-CPN without bupivacaine
Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL only.
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov