Intravenous Lidocaine For Pain Associated With Pancreatic Cancer And Chronic Pancreatitis

Study Overview

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.

N/A

Pancreatic Cancer
Chronic Pancreatitis

DRUG: Lidocaine IV

W21_005 # 21.007

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-08-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-09-28
First Submitted that Met QC Criteria 2023-06-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-10-02
First Posted (ACTUAL) 2023-06-18	Results First Posted N/A	Last Verified 2023-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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	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 pa

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

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 pa

Primary Outcome Measures	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	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)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Marc G. Besselink, MD PhD MSc, Amsterdam UMC, Academic Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record