EUS-CPN With and Without Bupivacaine

NCT04951804 | Recruiting DMC

• 1 other identifier: 21.151
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Likert pain scores

  Pain scale used : 7-point Likert scale for pain (minimum value is 0, maximum value is 6; higher scores mean a worse outcome)

  Day 0 and Day 30

Secondary Outcomes (6)

• Difference in pain scores at T0 vs all other follow-up time points

  Days 0, 3, 7, 30, 60, 90, 120

• Time to discharge from the endoscopy unit

  From time of arrival in the recovery room after the intervention to time of discharge from the recovery room. The estimated period of time over which the event is assessed is up to two hours

• Narcotic usage

  Narcotic usage for the 3 day-period preceding Days 0, 60 and 120

• Adverse events

  Days 0, 3, 7, 30, 60, 90, 120

• Survival

  Up to 18 months

Study Arms (2)

EUS-CPN with bupivacaine

ACTIVE COMPARATOR

Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL preceded by injection of 10 ml of bupivacaine 0.5%.

Procedure: EUS-CPN with bupivacaine

EUS-CPN without bupivacaine

EXPERIMENTAL

Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL only.

Procedure: EUS-CPN without bupivacaine

Interventions

EUS-CPN without bupivacaine PROCEDURE

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 without bupivacaine

EUS-CPN with bupivacaine PROCEDURE

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.

EUS-CPN with bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

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

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Related Publications (1)

• Esmail 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 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• ANAND V SAHAI, MD

  Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHARLES MACKAY, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 7, 2021
• Study Start: October 7, 2021
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)