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Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study. | LitMetric

AI Article Synopsis

  • Many cancer patients suffer from neuropathic pain that is not effectively managed by current analgesic therapies, which can have side effects and limited effectiveness.
  • The study aims to evaluate lidocaine, a local anesthetic, administered through a continuous subcutaneous infusion as a potential treatment, utilizing a mixed-methods pilot approach that includes a randomized controlled trial and qualitative analysis of patient experiences.
  • Ethical considerations for participant safety are included in the trial design, and the results will be published in academic journals and presented at conferences to share insights on the treatment's efficacy and safety.

Article Abstract

Introduction: Many patients experience unrelieved neuropathic cancer-related pain. Most current analgesic therapies have psychoactive side effects, lack efficacy data for this indication and have potential medication-related harms. The local anaesthetic lidocaine (lignocaine) has the potential to help manage neuropathic cancer-related pain when administered as an extended, continuous subcutaneous infusion. Data support lidocaine as a promising, safe agent in this setting, warranting further evaluation in robust, randomised controlled trials. This protocol describes the design of a pilot study to evaluate this intervention and explains the pharmacokinetic, efficacy and adverse effects evidence informing the design.

Methods And Analysis: A mixed-methods pilot study will determine the feasibility of an international first, definitive phase III trial to evaluate the efficacy and safety of an extended continuous subcutaneous infusion of lidocaine for neuropathic cancer-related pain. This study will comprise: a phase II double-blind randomised controlled parallel-group pilot of subcutaneous infusion of lidocaine hydrochloride 10% w/v (3000 mg/30 mL) or placebo (sodium chloride 0.9%) over 72 hours for neuropathic cancer-related pain, a pharmacokinetic substudy and a qualitative substudy of patients' and carers' experiences. The pilot study will provide important safety data and help inform the methodology of a definitive trial, including testing proposed recruitment strategy, randomisation, outcome measures and patients' acceptability of the methodology, as well as providing a signal of whether this area should be further investigated.

Ethics And Dissemination: Participant safety is paramount and standardised assessments for adverse effects are built into the trial protocol. Findings will be published in a peer-reviewed journal and presented at conferences. This study will be considered suitable to progress to a phase III study if there is a completion rate where the CI includes 80% and excludes 60%. The protocol and Patient Information and Consent Form have been approved by Sydney Local Health District (Concord) Human Research Ethics Committee 2019/ETH07984 and University of Technology Sydney ETH17-1820.

Trial Registration Number: ANZCTR ACTRN12617000747325.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9945039PMC
http://dx.doi.org/10.1136/bmjopen-2022-066125DOI Listing

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