Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis

Pancreatic Cancer Clinical Trial

— LIDOPAN  

Official title:

Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis (LIDOPAN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05906615
• Other study ID #: W21_005 # 21.007
• Status: Completed
• Phase: Phase 2
• Start date: January 14, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Drug:
• Lidocaine IV
Administration of IV lidocaine will take place according to the standard protocol as is currently already used in daily clinical practice. First, a lidocaine bolus of 1.5mg/kg is administered, followed by a continuous infusion of 1.5mg/kg/hour. When no pain relief is noticed, each 15 minutes the dose is raised with 1ml up to a maximum of 2mg/kg/hour. If again no pain relief is noticed, the anesthesiologist is consulted. When the anesthesiologist agrees, and no side effects occur, lidocaine infusion can be increased up to a maximum of 2.5mg/kg/hour, with a maximum of 250mg/hour. When there is a pain response - pain is reduced with at least two NRS points or 30% from baseline - that dose is administered for two hours continuously. Following treatment the patient will be observed for an hour before leaving the hospital or recovery unit, again, all according to current daily clinical practice.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, locatie AMC	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)	Directly after treatment
Secondary	Effect of treatment	Assed by the Global Perceived effect (scale: 0-7, higher score indicate better outcome)	After two weeks, and one-three-six months
Secondary	Pain score	Assessed by the Numeric Rating Scale (scale: 0-10, higher score indicate worse outcome)	Directly after treatment, two weeks, and after one-three-six months
Secondary	Pain score long term	Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)	After two weeks, and one-three-six months
Secondary	Quality of life (SF-12)	Assessed by the SF-12 (scale: 0-100: higher scores indicate better quality of life)	Baseline, and after one-three-six months
Secondary	Dose of intravenous lidocaine administered	in mg/kg	During intervention
Secondary	Number of total performed treatments with intravenous lidocaine per participant		During follow-up (six months)
Secondary	Numer of participants with minor or major complications		During follow-up (six months)
Secondary	Dose reduction of opioids		During follow-up (six months)