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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Chronic Pancreatitis
• Intervention / Treatment: Drug: Lidocaine IV

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Amsterdam UMC, locatie AMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Intravenous lidocaine; Monitored intravenous lidocaine infusion for patients with CP and pancreatic cancer is already current practice in the participating centers. Patients undergo treatment in the recovery unit of the anesthesiology department, for early detection of possible, although highly unlikely adverse events such as anaphylactic reactions, arrhythmias or hypotension. At the recovery unit continuous monitoring is possible and treatment of the above mentioned side effects can be easily provided. Continuous monitoring includes a 3-lead ECG, saturation, and blood pressure control every 15 minutes.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)	Directly after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Dose of intravenous lidocaine administered	in mg/kg	During intervention
Number of total performed treatments with intravenous lidocaine per participant		During follow-up (six months)
Numer of participants with minor or major complications		During follow-up (six months)
Dose reduction of opioids		During follow-up (six months)

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Marc G. Besselink, MD PhD MSc, Amsterdam UMC, Academic Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Disease Attributes; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Chronic Disease; Pancreatic Neoplasms; Pancreatitis; Pancreatitis, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: W21_005 # 21.007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No