Lidocaine (lignocaine) for Neuropathic Cancer Pain – Feasibility study (LiCPain)

• Register: ANZCTR
• Last refreshed on: 20 August 2018
• Main ID: ACTRN12617000747325
• Date of registration: 22/05/2017
• Prospective Registration: Yes
• Primary sponsor: University of Technology Sydney
• Public title: Lidocaine (lignocaine) for Neuropathic Cancer Pain – Feasibility study (LiCPain)
• Scientific title: A multi-centre double blind randomised controlled trial of continuous subcutaneous lidocaine (lignocaine) for the management of neuropathic cancer pain - a feasibility study.
• Date of first enrolment: 1/10/2018
• Target sample size: 36
• Recruitment status: Not yet recruiting
• URL: http://www.anzctr.org.au/ACTRN12617000747325.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Phase 2

Health Condition(s) or Problem(s) studied

Neuropathic Cancer Pain

Intervention(s)

Lidocaine (lignocaine) hydrochloride 10%w/v (500mg/5ml) delivered via continuous subcutaneous infusion over 72 hours. Dose will be titrated from 1 to 2 mg/kg/hr with a maximum dose of 120mg/hour.

The continuous subcutaneous infusion of lidocaine (lignocaine)/placebo will commence on day 1 at T0 of the trial at 1mg/kg/hr (maximum 120mg/hr) .

The dose will be increased by 0.5mg/kg/hr every 24 hours to a maximum of 2mg/kg/hr or 120mg/hr (whichever is lower)
Unless
*If the patient’s average and worst pain score in the last 24 hours is 3/10, the dose will remain the same.
*If there are any new or increased toxicity these will be managed according to protocol. If the toxicity is not detailed, the study investigator will be informed and will make a clinical judgement which may include treatment of the symptom, dose reduction or cessation of infusion. If the assessing member is part of the clinical team, management will be guided by the study investigator or delegate.

After 72 hours (on day 4) the infusion will be ceased.

The infusion will be administered by nursing staff as an inpatient.