Clinical trial · Interventional
EUS-CPN With and Without Bupivacaine
A Randomized Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Neurolysis (EUS-CPN) With and Without Bupivacaine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-CPN with bupivacaine | Procedure | — | UNRESOLVED |
| EUS-CPN without bupivacaine | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EUS-CPN with bupivacaine
- description
- Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL preceded by injection of 10 ml of bupivacaine 0.5%.
- interventionNames
- Procedure: EUS-CPN with bupivacaine
- type
- EXPERIMENTAL
- label
- EUS-CPN without bupivacaine
- description
- Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL only.
- interventionNames
- Procedure: EUS-CPN without bupivacaine
Primary outcomes (1)
- measure
- Change in Likert pain scores
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Malignant-appearing pancreatic mass, or proven pancreatic cancer involving the pancreatic genu, body, or tail 2. Any level of abdominal or back pain considered to be potentially related to the mass: 1. New onset pain (\<3 months) 2. Constant 3. Centrally located 4. With or without irradiation to the back 5. No obvious other source of pain based on history and physical examination by the attending endosonographer 3. No possibility of surgical management 4. Signed, informed consent 5. Celiac axis accessible for bilateral neurolysis at EUS. Exclusion Criteria: 1\. Allergy to bupivacaine
References
Publications (1)
- DERIVEDEsmail E, Paquin SC, Sahai AV. Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine. Trials. 2023 Sep 8;24(1):576. doi: 10.1186/s13063-023-07487-7. PMID 37684697