RT Journal Article
SR Electronic
T1 OP-9 Should we give up on lidocaine trials? Implications of preliminary results of the lidocaine for neuropathic cancer pain feasibility study (LICPAIN)
JF BMJ Supportive & Palliative Care
JO BMJ Support Palliat Care
FD British Medical Journal Publishing Group
SP A6
OP A7
DO 10.1136/spcare-2024-ANZSPM.9
VO 14
IS Suppl 3
A1 Lee, Jessica
A1 Huang, Emily
A1 Hutton, Eugenia
A1 Rao-Newton, Angela
A1 Aggarwal, Rajesh
A1 Seah, Davinia
A1 Lovell, Melanie
A1 Ayoub, Chadi
A1 Vandersman, Priyanka
A1 Butcher, Belinda
A1 Currow, David
A1 Phillips, Jane
A1 McLachlan, Andrew
A1 Noble, Beverly
A1 Brown, Linda
A1 McCaffrey, Nikki
A1 Fazekas, Belinda
A1 Chye, Richard
A1 Sanderson, Christine
A1 Sheehan, Caitlin
A1 Aggarwal, Ghauri
A1 Urban, Katalin
A1 Linton, Anthony
A1 Kow, Marion
A1 George, Rachel
A1 Agar, Meera
YR 2024
UL http://spcare.bmj.com/content/14/Suppl_3/A6.2.abstract
AB Background Lidocaine infusions are used variably around Australia to treat people with neuropathic cancer pain. The LiCPAIN trial aimed to determine the feasibility of conducting a double-blind randomised controlled trial of continuous subcutaneous lidocaine for neuropathic cancer pain. The primary objective wasMethods Palliative care inpatients at 5 metropolitan NSW sites were randomised to a 72-hour continuous infusion of subcutaneous lidocaine or placebo at 1–2mg/kg/hr, capped at 120mg/kg/hr. Participants had cancer pain with neuropathic features, with a worst pain score of four out of ten or higher in the past 24 hours despite adequate trial of opioid and adjuvant analgesics. Exclusion criteria included increased risk of cardiac or neurological toxicity due to pre-existing conditions, altered metabolism and drug interactions. Efficacy and toxicity assessment informed infusion titration daily.Results Seventeen participants were randomised out of 124 screened. The mean age was 64.1 years (SD=11.2) and 77% were female. The mean weight was 70.8kg (SD=23.3). The mean worst pain score at baseline was 7.8 (SD=1.2) with a mean daily oral morphine-equivalent regular opioid use was 189.2mg (SD=160.6).The completion rate of study medication and procedures was 93% (95% confidence interval 5%) and 88% completed 72 hours of study medication. Four participants were randomised in the first eighteen months and it took 54 months to reach sample size.There was no significant difference between the number of intervention and placebo participants who had a reduction of 1 or more points for worst pain on the BPI-SF (50% vs 57% p=0.77). The mean change in worst pain on the BPI-SF was –0.7 (SD=XX) in the intervention group and –2.0 (SD=XX) in the placebo group (p=0.23).Discussion This study met the primary outcome demonstrating that it is feasible for randomised participants to complete the study medication and procedures. The high placebo response rate and wide confidence interval informs us that a large sample size would be required to power a definitive phase III study. This data suggests that while the study design is feasible once participants are recruited, the slow recruitment rate would necessitate a large number of sites and resources to determine the benefit of continuous subcutaneous infusion of lidocaine using this methodology. These results inform future clinical trials of lidocaine and other analgesics which may need to consider how to optimise recruitment through study design and processes.This feasibility study is not powered for efficacy, limiting the significance of findings for pain reduction. The placebo response rate in this study was very high compared to other pain studies which commonly find a reduction of about 20% in pain intensity.The evidence base in palliative care has grown rapidly in the past 30 years transforming the way we practice medicine. This study provides important insights into design and feasibility of clinical trials of lidocaine for people with neuropathic cancer pain.