Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis

NCT05906615 | Completed Phase 2

• 1 other identifier: W21_005 # 21.007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Pain score

  Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)

  Directly after treatment

Secondary Outcomes (8)

• Effect of treatment

  After two weeks, and one-three-six months

• Pain score

  Directly after treatment, two weeks, and after one-three-six months

• Pain score long term

  After two weeks, and one-three-six months

• Quality of life (SF-12)

  Baseline, and after one-three-six months

• Dose of intravenous lidocaine administered

  During intervention

Study Arms (1)

Intravenous lidocaine

OTHER

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

Interventions

Lidocaine IV DRUG

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.

Intravenous lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc G. Besselink, MD PhD MSc

  Amsterdam UMC, Academic Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. M.G. Besselink

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: June 18, 2023
• Study Start: January 14, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)