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NCT Number: NCT05906615

Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pain score

    Time frame: Directly after treatment

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

Secondary outcomes

  1. Effect of treatment

    Time frame: After two weeks, and one-three-six months

    Assed by the Global Perceived effect (scale: 0-7, higher score indicate better outcome)

  2. Pain score

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

    Assessed by the Numeric Rating Scale (scale: 0-10, higher score indicate worse outcome)

  3. Pain score long term

    Time frame: After two weeks, and one-three-six months

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

  4. Quality of life (SF-12)

    Time frame: Baseline, and after one-three-six months

    Assessed by the SF-12 (scale: 0-100: higher scores indicate better quality of life)

  5. Dose of intravenous lidocaine administered

    Time frame: During intervention

    in mg/kg

  6. Number of total performed treatments with intravenous lidocaine per participant

    Time frame: During follow-up (six months)

  7. Numer of participants with minor or major complications

    Time frame: During follow-up (six months)

  8. Dose reduction of opioids

    Time frame: During follow-up (six months)

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Acronym: LIDOPAN

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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