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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, Netherlands
Pain score
Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)
Time frame: Directly after treatment
Effect of treatment
Assed by the Global Perceived effect (scale: 0-7, higher score indicate better outcome)
Time frame: After two weeks, and one-three-six months
Pain score
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
Pain score long term
Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)
Time frame: 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)
Time frame: Baseline, and after one-three-six months
Dose of intravenous lidocaine administered
in mg/kg
Time frame: During intervention
Number of total performed treatments with intravenous lidocaine per participant
Time frame: During follow-up (six months)
Numer of participants with minor or major complications
Time frame: During follow-up (six months)
Dose reduction of opioids
Time frame: During follow-up (six months)
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