Back to resultsIntravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis (LIDOPAN)
Primary Purpose
Pancreatic Cancer, Chronic Pancreatitis
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Lidocaine IV
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
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.
Sites / Locations
- Amsterdam UMC, locatie AMC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intravenous lidocaine
Arm Description
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.
Outcomes
Primary Outcome Measures
Pain score
Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)
Secondary Outcome Measures
Effect of treatment
Assed by the Global Perceived effect (scale: 0-7, higher score indicate better outcome)
Pain score
Assessed by the Numeric Rating Scale (scale: 0-10, higher score indicate worse outcome)
Pain score long term
Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)
Quality of life (SF-12)
Assessed by the SF-12 (scale: 0-100: higher scores indicate better quality of life)
Dose of intravenous lidocaine administered
in mg/kg
Number of total performed treatments with intravenous lidocaine per participant
Numer of participants with minor or major complications
Dose reduction of opioids
Full Information
NCT ID
NCT05906615
First Posted
August 29, 2022
Last Updated
September 28, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT05906615
Brief Title
Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis
Acronym
LIDOPAN
Official Title
Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis (LIDOPAN)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Chronic Pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous lidocaine
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine IV
Intervention Description
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 Outcome Measure Information:
Title
Pain score
Description
Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)
Time Frame
Directly after treatment
Secondary Outcome Measure Information:
Title
Effect of treatment
Description
Assed by the Global Perceived effect (scale: 0-7, higher score indicate better outcome)
Time Frame
After two weeks, and one-three-six months
Title
Pain score
Description
Assessed by the Numeric Rating Scale (scale: 0-10, higher score indicate worse outcome)
Time Frame
Directly after treatment, two weeks, and after one-three-six months
Title
Pain score long term
Description
Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)
Time Frame
After two weeks, and one-three-six months
Title
Quality of life (SF-12)
Description
Assessed by the SF-12 (scale: 0-100: higher scores indicate better quality of life)
Time Frame
Baseline, and after one-three-six months
Title
Dose of intravenous lidocaine administered
Description
in mg/kg
Time Frame
During intervention
Title
Number of total performed treatments with intravenous lidocaine per participant
Time Frame
During follow-up (six months)
Title
Numer of participants with minor or major complications
Time Frame
During follow-up (six months)
Title
Dose reduction of opioids
Time Frame
During follow-up (six months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc G. Besselink, MD PhD MSc
Organizational Affiliation
Amsterdam UMC, Academic Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC, locatie AMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis
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