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

Lee, JT; Lovell, MR; Ritchie, M; Butcher, BE; Sheehan, C; Fazekas, B; McLachlan, A; McCaffrey, N; Phillips, JL; Linton, A; Aggarwal, R; Seah, D; Kow, M; George, R; Chye, R; Noble, B; Currow, D; Aggarwal, G; Mittal, D; Ayoub, C; Hutton, E; Rao, A; Urban, K; Vandersman, P; Sanderson, C; Agar, M

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

Lee, JT Lovell, MR Ritchie, M Butcher, BE Sheehan, C Fazekas, B McLachlan, A McCaffrey, N Phillips, JL Linton, A Aggarwal, R Seah, D Kow, M George, R Chye, R Noble, B Currow, D

Aggarwal, G Mittal, D Ayoub, C Hutton, E Rao, A Urban, K Vandersman, P Sanderson, C Agar, M

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Publisher:: ELSEVIER SCIENCE INC
Publication Type:: Journal Article
Citation:: J Pain Symptom Manage, 2025, 70, (3), pp. 267-277.e6
Issue Date:: 2025-09

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Field	Value	Language
dc.contributor.author	Lee, JT
dc.contributor.author	Lovell, MR
dc.contributor.author	Ritchie, M
dc.contributor.author	Butcher, BE
dc.contributor.author	Sheehan, C
dc.contributor.author	Fazekas, B
dc.contributor.author	McLachlan, A
dc.contributor.author	McCaffrey, N
dc.contributor.author	Phillips, JL
dc.contributor.author	Linton, A
dc.contributor.author	Aggarwal, R
dc.contributor.author	Seah, D
dc.contributor.author	Kow, M
dc.contributor.author	George, R
dc.contributor.author	Chye, R
dc.contributor.author	Noble, B
dc.contributor.author	Currow, D https://orcid.org/0000-0003-1988-1250
dc.contributor.author	Aggarwal, G
dc.contributor.author	Mittal, D
dc.contributor.author	Ayoub, C
dc.contributor.author	Hutton, E
dc.contributor.author	Rao, A
dc.contributor.author	Urban, K
dc.contributor.author	Vandersman, P
dc.contributor.author	Sanderson, C
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119
dc.date.accessioned	2026-02-19T23:20:12Z
dc.date.available	2025-05-25
dc.date.available	2026-02-19T23:20:12Z
dc.date.issued	2025-09
dc.identifier.citation	J Pain Symptom Manage, 2025, 70, (3), pp. 267-277.e6
dc.identifier.issn	0885-3924
dc.identifier.issn	1873-6513
dc.identifier.uri	http://hdl.handle.net/10453/193646
dc.description.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.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	ELSEVIER SCIENCE INC
dc.relation.ispartof	J Pain Symptom Manage
dc.relation.isbasedon	10.1016/j.jpainsymman.2025.05.015
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	11 Medical and Health Sciences
dc.subject.classification	Anesthesiology
dc.subject.classification	32 Biomedical and clinical sciences
dc.subject.classification	42 Health sciences
dc.subject.mesh	Humans
dc.subject.mesh	Lidocaine
dc.subject.mesh	Male
dc.subject.mesh	Female
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Middle Aged
dc.subject.mesh	Cancer Pain
dc.subject.mesh	Anesthetics, Local
dc.subject.mesh	Neuralgia
dc.subject.mesh	Aged
dc.subject.mesh	Double-Blind Method
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Infusions, Subcutaneous
dc.subject.mesh	Palliative Care
dc.subject.mesh	Pain Measurement
dc.subject.mesh	Feasibility Studies
dc.subject.mesh	Adult
dc.subject.mesh	Neoplasms
dc.subject.mesh	Humans
dc.subject.mesh	Neoplasms
dc.subject.mesh	Neuralgia
dc.subject.mesh	Lidocaine
dc.subject.mesh	Anesthetics, Local
dc.subject.mesh	Pain Measurement
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Palliative Care
dc.subject.mesh	Feasibility Studies
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Double-Blind Method
dc.subject.mesh	Adult
dc.subject.mesh	Aged
dc.subject.mesh	Middle Aged
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Infusions, Subcutaneous
dc.subject.mesh	Cancer Pain
dc.subject.mesh	Humans
dc.subject.mesh	Lidocaine
dc.subject.mesh	Male
dc.subject.mesh	Female
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Middle Aged
dc.subject.mesh	Cancer Pain
dc.subject.mesh	Anesthetics, Local
dc.subject.mesh	Neuralgia
dc.subject.mesh	Aged
dc.subject.mesh	Double-Blind Method
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Infusions, Subcutaneous
dc.subject.mesh	Palliative Care
dc.subject.mesh	Pain Measurement
dc.subject.mesh	Feasibility Studies
dc.subject.mesh	Adult
dc.subject.mesh	Neoplasms
dc.title	Lidocaine for Neuropathic Cancer Pain (LiCPain): A Pilot Randomized Controlled Trial.
dc.type	Journal Article
utslib.citation.volume	70
utslib.location.activity	United States
utslib.for	11 Medical and Health Sciences
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/UTS Groups
pubs.organisational-group	University of Technology Sydney/UTS Groups/Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT)
pubs.organisational-group	University of Technology Sydney/UTS Groups/INSIGHT: Institute for Innovative Solutions for Wellbeing and Health
pubs.organisational-group	University of Technology Sydney/UTS Groups/Centre for Health Technologies (CHT)
utslib.copyright.status	open_access	*
dc.rights.license	This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0). To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/
dc.date.updated	2026-02-19T23:20:10Z
pubs.issue	3
pubs.publication-status	Published
pubs.volume	70
utslib.citation.issue	3

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.

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http://hdl.handle.net/10453/193646