Clinical trial NCT05906615: Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis
Official title: Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis (LIDOPAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Chronic Pancreatitis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pain is a major clinical problem for many patients with pancreatic cancer and chronic pancreatitis (CP).In pancreatic cancer, nearly 75% of patients suffer from pain at the time of diagnosis, with over 90% of patients in advanced stages. In CP, pain occurs in 80-90% of patients and strongly affects quality of life. For both conditions, the majority of pain is addressed using the WHO analgesic ladder. However, more invasive pain therapies are often necessary.

Currently, in several centers in the Netherlands, treatment with IV lidocaine is already used in clinical practice in patients with pancreatic cancer and CP. Based on practical experience, the majority of patients benefit from this therapy, however, its efficacy in terms of duration of pain relief, decrease in pain scores, increase in patient satisfaction and adverse events is unknown. Therefore, the aim of this study is to investigate the efficacy of monitored single intravenous infusion in patients with pancreatic cancer and CP.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older;
* NRS score ≥4 despite previous pain treatment with non-opioid analgesics, opioids or TCAs. Or pain treatment with non-opioid analgesics, opioids or TCAs with adequate effect on pain, but unable to reduce the opioids;
* For CP:

  * Diagnosis of CP based on the M-ANNHEIM diagnostic criteria;17
* For pancreatic cancer:

  * Diagnosis of pancreatic cancer (all stages)
  * Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  * Life expectancy ≥ 3 months;
* Consensus of surgeon/gastroenterologist and anesthesiologist for suitability for treatment

Exclusion Criteria:

* Patients with contra-indications for intravenous lidocaine i.e. medical history of non-adequate liver function, hypersensitivity to local anesthetics, New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months, shock, and conduction abnormalities (defined as second and third degree atrioventricular (AV) blocks, or atrial fibrillation);
* Patients who underwent invasive pain therapies: such as endoscopic treatment or surgery for chronic pancreatitis, and splanchnic nerves or coeliac plexus blocks, neurolysis, or PRF for pancreatic cancer.

Primary outcomes:
measure: Pain score
timeFrame: Directly after treatment
Secondary outcomes:
measure: Effect of treatment
timeFrame: After two weeks, and one-three-six months
measure: Pain score
timeFrame: Directly after treatment, two weeks, and after one-three-six months
measure: Pain score long term
timeFrame: After two weeks, and one-three-six months
measure: Quality of life (SF-12)
timeFrame: Baseline, and after one-three-six months
measure: Dose of intravenous lidocaine administered
timeFrame: During intervention
measure: Number of total performed treatments with intravenous lidocaine per participant
timeFrame: During follow-up (six months)
measure: Numer of participants with minor or major complications
timeFrame: During follow-up (six months)
measure: Dose reduction of opioids
timeFrame: During follow-up (six months)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, Academic Medical Center
name: Marc G. Besselink, MD PhD MSc
role: PRINCIPAL_INVESTIGATOR
References: