EUS-CPN With and Without Bupivacaine
ConditionPancreatic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Malignant-appearing pancreatic mass, or proven pancreatic cancer involving the pancreatic genu, body, or tail
New onset pain (<3 months)
Constant
Centrally located
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
EUS-CPN without bupivacaine
Procedure/SurgeryUnder 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
Procedure/SurgeryUnder 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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: EUS-CPN with bupivacaineActive comparator 1 intervention
Group B: EUS-CPN without bupivacaineExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
Day 0 and Day 30Secondary outcomes
1
Difference in pain scores at T0 vs all other follow-up time points
The 7-point Likert scale for pain (minimum value is 0, maximum value is 6; higher scores mean a worse outcome)
Time frame
Days 0, 3, 7, 30, 60, 90, 1202
Time to discharge from the endoscopy unit
Time spent in the recovery room following the procedure
Time frame
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 hours3
Narcotic usage
Change in cumulative narcotic usage between Day 0 and Day 60, and between Day 0 and Day 120
Time frame
Narcotic usage for the 3 day-period preceding Days 0, 60 and 1204
Adverse events
Rate of all intervention-specific adverse events (Using the American Society of Gastrointestinal Endoscopy classification)
Time frame
Days 0, 3, 7, 30, 60, 90, 120Sponsors and contacts
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Source ClinicalTrials.gov