Recruiting

EUS-CPN with Bupivacaine

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04951804

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EUS-CPN without bupivacaine

EUS-CPN with bupivacaine

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Study ID

NCT04951804

Start date

Oct 7, 2021

Status verified date

Apr, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

EUS-CPN without bupivacaine

Under conscious sedation, an echoendoscope is advanced into the stomach, just distal to the gastro-esophageal junction. The region of the celiac plexus is identified around the takeoff of the celiac artery from the aorta. Then, under real-time ultrasound guidance, a 19g needle is used to inject a neurolytic agent such as absolute alcohol around the base of the celiac artery.

EUS-CPN with bupivacaine

Under conscious sedation, an echoendoscope is advanced into the stomach, just distal to the gastro-esophageal junction. The region of the celiac plexus is identified around the takeoff of the celiac artery from the aorta. Then, under real-time ultrasound guidance, a 19g needle is used to firstly inject bupivacaine and secondly a neurolytic agent such as absolute alcohol around the base of the celiac artery.

Primary outcome measure

  • Change in Likert pain scores [ Time Frame: Day 0 and Day 30 ]

Central Contacts and Locations

Central contacts

CHARLES MACKAY, RN

514-890-8000charles.mackay.chum@ssss.gouv.qc.ca

Locations

Centre de recherche du Centre hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

CHARLES MACKAY, RN

514-890-8000charles.mackay.chum@ssss.gouv.qc.ca

Principal Investigator:

Anand V Sahai, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Pancreatic Cancer
  • Celiac plexus neurolysis
  • Bupivacaine
  • Endoscopic ultrasound
  • With Bupivacaine
  • Without Bupivacaine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-04-23.