Lidocaine for Neuropathic Cancer Pain (LiCPain): A Pilot Randomized Controlled Trial

Jessica T Lee¹, Melanie R Lovell², Megan Ritchie³, Belinda E Butcher⁴, Caitlin Sheehan⁵, Belinda Fazekas⁶, Andrew McLachlan⁷, Nikki McCaffrey⁸, Jane L Phillips⁹, Anthony Linton¹⁰, Rajesh Aggarwal¹¹, Davinia Seah¹², Marian Kow¹³, Rachel George¹³, Richard Chye¹⁴, Bev Noble¹⁵, David Currow¹⁶, Ghauri Aggarwal³, Dipti Mittal³, Chadi Ayoub¹⁷, Eugenia Hutton¹⁸, Angela Rao¹⁹, Kat Urban²⁰, Priyanka Vandersman²¹, Christine Sanderson²², Meera Agar⁶

Affiliations

¹ Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) (J.T.L., B.F., J.L.P., R.C., M.A.), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia; Concord Clinical School (J.T.L., M.R., A.L., G.A., D.M.), University of Sydney, Concord, New South Wales, Australia. Electronic address: jessica.lee1@health.nsw.gov.au.
² HammondCare (M.R.L.), Greenwich Palliative and Supportive Care Services, Sydney, New South Wales, Australia; Northern Clinical School (M.R.L.), University of Sydney, St Leonards, New South Wales, Australia.
³ Concord Centre for Palliative Care (M.R., G.A., D.M., E.H.), Concord Repatriation General Hospital, Concord, New South Wales, Australia; Concord Clinical School (J.T.L., M.R., A.L., G.A., D.M.), University of Sydney, Concord, New South Wales, Australia.
⁴ WriteSource Medical Pty Ltd (B.E.B.), Lane Cove, New South Wales, Australia; Sydney Pharmacy School (B.B., A.M.), The University of Sydney, Sydney, New South Wales, Australia.
⁵ Palliative Care (C.S.), Calvary Healthcare, Kogarah, New South Wales, Australia.
⁶ Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) (J.T.L., B.F., J.L.P., R.C., M.A.), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
⁷ Sydney Pharmacy School (B.B., A.M.), The University of Sydney, Sydney, New South Wales, Australia.
⁸ Deakin Health Economics (N.M.), Deakin University, Melbourne, Victoria, Australia.
⁹ Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) (J.T.L., B.F., J.L.P., R.C., M.A.), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia; Centre for Healthcare Transformation (J.L.P.), School of Nursing, Faculty of Health, Queensland University of Technology, Brisbane, Australia.
¹⁰ Concord Clinical School (J.T.L., M.R., A.L., G.A., D.M.), University of Sydney, Concord, New South Wales, Australia; Oncology (A.L.), Concord Repatriation General Hospital, Concord, New South Wales, Australia.
¹¹ Palliative Care (R.A.), South West Sydney Local Health District, Bankstown, New South Wales, Australia.
¹² Sacred Heart Supportive & Palliative Care (D.S., R.C.), St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
¹³ Pharmacy (M.K., R.G.), Concord Repatriation General Hospital, Concord, New South Wales, Australia.
¹⁴ Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) (J.T.L., B.F., J.L.P., R.C., M.A.), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia; Sacred Heart Supportive & Palliative Care (D.S., R.C.), St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
¹⁵ Consumer representative (B.N.), Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
¹⁶ Flinders Ageing Alliance (D.C.), Flinders University, Bedford Park, South Australia.
¹⁷ Cardiovascular Medicine, Mayo Clinic (C.A.), Scottsdale, Arizona, USA.
¹⁸ Concord Centre for Palliative Care (M.R., G.A., D.M., E.H.), Concord Repatriation General Hospital, Concord, New South Wales, Australia.
¹⁹ School of Nursing, College of Health and Medicine (A.R.), University of Tasmania, Sydney, New South Wales, Australia.
²⁰ Palliative Care, Northern NSW Local Health District (K.U.), Lismore, New South Wales, Australia.
²¹ Research Centre for Palliative Care, Death and Dying (P.V.), Flinders University, South Australia, Australia.
²² Territory Palliative - Central Australia (C.S.), Northern Territory, Australia.

PMID: 40466924
DOI: 10.1016/j.jpainsymman.2025.05.015

Free article

Randomized Controlled Trial

Lidocaine for Neuropathic Cancer Pain (LiCPain): A Pilot Randomized Controlled Trial

Jessica T Lee et al. J Pain Symptom Manage. 2025 Sep.

Free article

. 2025 Sep;70(3):267-277.e6.

doi: 10.1016/j.jpainsymman.2025.05.015. Epub 2025 Jun 2.

Authors

Affiliations

¹ Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) (J.T.L., B.F., J.L.P., R.C., M.A.), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia; Concord Clinical School (J.T.L., M.R., A.L., G.A., D.M.), University of Sydney, Concord, New South Wales, Australia. Electronic address: jessica.lee1@health.nsw.gov.au.
² HammondCare (M.R.L.), Greenwich Palliative and Supportive Care Services, Sydney, New South Wales, Australia; Northern Clinical School (M.R.L.), University of Sydney, St Leonards, New South Wales, Australia.
³ Concord Centre for Palliative Care (M.R., G.A., D.M., E.H.), Concord Repatriation General Hospital, Concord, New South Wales, Australia; Concord Clinical School (J.T.L., M.R., A.L., G.A., D.M.), University of Sydney, Concord, New South Wales, Australia.
⁴ WriteSource Medical Pty Ltd (B.E.B.), Lane Cove, New South Wales, Australia; Sydney Pharmacy School (B.B., A.M.), The University of Sydney, Sydney, New South Wales, Australia.
⁵ Palliative Care (C.S.), Calvary Healthcare, Kogarah, New South Wales, Australia.
⁶ Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) (J.T.L., B.F., J.L.P., R.C., M.A.), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
⁷ Sydney Pharmacy School (B.B., A.M.), The University of Sydney, Sydney, New South Wales, Australia.
⁸ Deakin Health Economics (N.M.), Deakin University, Melbourne, Victoria, Australia.
⁹ Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) (J.T.L., B.F., J.L.P., R.C., M.A.), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia; Centre for Healthcare Transformation (J.L.P.), School of Nursing, Faculty of Health, Queensland University of Technology, Brisbane, Australia.
¹⁰ Concord Clinical School (J.T.L., M.R., A.L., G.A., D.M.), University of Sydney, Concord, New South Wales, Australia; Oncology (A.L.), Concord Repatriation General Hospital, Concord, New South Wales, Australia.
¹¹ Palliative Care (R.A.), South West Sydney Local Health District, Bankstown, New South Wales, Australia.
¹² Sacred Heart Supportive & Palliative Care (D.S., R.C.), St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
¹³ Pharmacy (M.K., R.G.), Concord Repatriation General Hospital, Concord, New South Wales, Australia.
¹⁴ Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) (J.T.L., B.F., J.L.P., R.C., M.A.), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia; Sacred Heart Supportive & Palliative Care (D.S., R.C.), St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
¹⁵ Consumer representative (B.N.), Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
¹⁶ Flinders Ageing Alliance (D.C.), Flinders University, Bedford Park, South Australia.
¹⁷ Cardiovascular Medicine, Mayo Clinic (C.A.), Scottsdale, Arizona, USA.
¹⁸ Concord Centre for Palliative Care (M.R., G.A., D.M., E.H.), Concord Repatriation General Hospital, Concord, New South Wales, Australia.
¹⁹ School of Nursing, College of Health and Medicine (A.R.), University of Tasmania, Sydney, New South Wales, Australia.
²⁰ Palliative Care, Northern NSW Local Health District (K.U.), Lismore, New South Wales, Australia.
²¹ Research Centre for Palliative Care, Death and Dying (P.V.), Flinders University, South Australia, Australia.
²² Territory Palliative - Central Australia (C.S.), Northern Territory, Australia.

PMID: 40466924
DOI: 10.1016/j.jpainsymman.2025.05.015

Abstract

Context: Extended continuous subcutaneous infusion of lidocaine for neuropathic cancer pain is currently used in clinical practice.

Objective: To determine the feasibility of conducting an adequately powered, multisite, double-blind, parallel group, titrated dose, randomized controlled trial of continuous subcutaneous infusion of lidocaine versus placebo in palliative care patients with neuropathic cancer pain.

Methods: Adults with neuropathic cancer pain were randomized to receive lidocaine hydrochloride 10%w/v (3000 mg/30 mL) diluted in sodium chloride 0.9% or sodium chloride 0.9% as a continuous subcutaneous infusion titrated daily for 72 hours. The dose increased from 1 to 2 mg/kg/h, capped at 120mg/hour (2800mg/day, rounded down).

Results: Seventeen participants were recruited over 54 months. There was a 93% [95%CI 88%-98%] completion rate of study medication and procedures meeting the predefined feasibility criteria. Eighty-eight percent of participants completed 72 hours of study medication. Treatment-emergent adverse events were infrequent and generally mild or moderate nervous system, cardiac and vascular abnormalities. There were no electrocardiogram abnormalities. Rapid titration from 1 to 2 mg/kg/h was tolerated. Both intervention and control groups demonstrated a reduction in pain intensity with no significant difference.

Conclusion: This pilot demonstrates that a phase III clinical trial of extended continuous subcutaneous infusion of lidocaine for neuropathic cancer pain is feasible and provides important insights into modifications required to improve recruitment. Serum levels and relative safety suggest higher lidocaine doses could be cautiously evaluated. As the only prospective trial we are aware of to date, this trial informs clinical use of subcutaneous lidocaine infused over days.

Keywords: Palliative care; cancer pain; feasibility; lidocaine; pain control; randomized controlled trial.

PubMed Disclaimer

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions

LinkOut - more resources

Full Text Sources
- ClinicalKey
- Elsevier Science
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Lidocaine for Neuropathic Cancer Pain (LiCPain): A Pilot Randomized Controlled Trial

Affiliations

Lidocaine for Neuropathic Cancer Pain (LiCPain): A Pilot Randomized Controlled Trial

Authors

Affiliations

Abstract

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical