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Pancreatic CancerPhase 2LIDOPANNCT05906615

Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis

A Phase 2 study testing Lidocaine IV in people with Pancreatic Cancer and Chronic Pancreatitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pancreatic Cancer, Chronic Pancreatitis
What is being tested?
Lidocaine IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteNetherlands
Study dates
14 Jan 2021to 1 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • Life expectancy ≥ 3 months;
  • Consensus of surgeon/gastroenterologist and anesthesiologist for suitability for treatment

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Amsterdam UMC, locatie AMC

    Amsterdam, North Holland, 1105 AZ

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Lidocaine IV
Medical subject headings
Pancreatic Neoplasms, Pancreatitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine IVDrug

    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.

Study groups in NCT05906615
Study groupRoleWhat they receive
Intravenous lidocaineOtherMonitored 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.
Receives: Drug: Lidocaine IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score

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

    Measured: Directly after treatment

Secondary outcomes (8)

  1. Effect of treatment

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

    Measured: After two weeks, and one-three-six months

  2. Pain score

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

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

  3. Pain score long term

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

    Measured: After two weeks, and one-three-six months

  4. Quality of life (SF-12)

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

    Measured: Baseline, and after one-three-six months

  5. Dose of intravenous lidocaine administered

    in mg/kg

    Measured: During intervention

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

    Measured: During follow-up (six months)

  7. Numer of participants with minor or major complications

    Measured: During follow-up (six months)

  8. Dose reduction of opioids

    Measured: During follow-up (six months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start14 Jan 2021
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05906615
Sponsor's protocol ID
W21_005 # 21.007
Acronym
LIDOPAN
Status last verified
Sep 2023
First submitted
29 Aug 2022
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lidocaine IV in people with Pancreatic Cancer and Chronic Pancreatitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: Directly after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05906615.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

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