EUS-CPN With and Without Bupivacaine
Recruiting now · Not applicable
Conditions studied: Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT04951804
- Run by
- Centre hospitalier de l'Université de Montréal (CHUM)
- People needed
- 180
- Starts
- 2021-10-07
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Allergy to bupivacaine
Where it is running
- Centre de recherche du Centre hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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