Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis

Phase 2

Completed

• Conditions: Chronic Pancreatitis; Pancreatic Cancer
• Interventions: Drug: Lidocaine IV

• Registration Number: NCT05906615
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-14
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-18
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous lidocaine	Lidocaine IV	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.

Primary Outcome Measures

Name	Time	Method
Pain score	Directly after treatment	Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)

Secondary Outcome Measures

Name	Time	Method
Dose of intravenous lidocaine administered	During intervention	in mg/kg
Number of total performed treatments with intravenous lidocaine per participant	During follow-up (six months)
Pain score	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)
Numer of participants with minor or major complications	During follow-up (six months)
Dose reduction of opioids	During follow-up (six months)
Effect of treatment	After two weeks, and one-three-six months	Assed by the Global Perceived effect (scale: 0-7, higher score indicate better outcome)
Pain score long term	After two weeks, and one-three-six months	Assessed by the Brief Pain inventory (scale: 0-10, higher score indicate worse outcome)
Quality of life (SF-12)	Baseline, and after one-three-six months	Assessed by the SF-12 (scale: 0-100: higher scores indicate better quality of life)

Trial Locations

Locations (1)

Amsterdam UMC, locatie AMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands