Lidocaine (lignocaine) for Neuropathic Cancer Pain – Feasibility study (LiCPain)
A multi-centre double blind randomised controlled trial of continuous subcutaneous lidocaine (lignocaine) for the management of neuropathic cancer pain - a feasibility study.
University of Technology Sydney
36 participants
Oct 1, 2018
Interventional
Conditions
Summary
The primary purpose of this trial is to evaluate the feasibility, efficacy and toxicity of continuous lignocaine for the treatment of neuropathic pain in cancer patients. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over, have been diagnosed with cancer (solid tumour or haematological) and have neuropathic pain related to the cancer or its treatment with a worst pain score of at least 4 out of 11 in the past 24 hours. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either lignocaine or sham treatment with saline. Participants will receive the allocated treatment as a continuous subcutaneous injection for 72 hours. The participant must be admitted to hospital during this treatment. The dose may be altered at 24 and 48 hours if the participant still experiences moderate or worse pain and has no serious adverse effects.. All participants will have assessments daily for the three days of treatment and weekly by phone up to 29 days after the start of treatment. Assessments will include sensory testing to test pain levels, questionnaires and blood samples. It is hoped that the findings of this trial will provide information to inform a larger trial on whether the administration of lignocaine/sham treatment, and the trial assessments are feasible, as well as providing some initial information on the efficacy and safety of this treatment for neuropathic pain in cancer patients.
Eligibility
Inclusion Criteria15
- Age 18 years or more
- English speaking and able to read study questionnaires (5th grade level)
- Able to complete study assessments and complying with the study procedures
- Ability to provide informed written consent
- Participant is willing to be an inpatient for the duration of the trial
- Pain related to cancer or its treatment with an worst pain score of 4 or greater on an 11 point numerical rating scale in the past 24 hours
- Patient’s cancer may be solid tumour or haematological
- A score of 12 or greater on the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale
- An adequate trial of opioid medication defined as titration to the maximum tolerated dose as limited by adverse effects or titration to at least a dose of 60mg/day oral morphine equivalent, for at least 24 hours
- or inability to tolerate opioids (eg due to allergy)
- An adequate trial of at least one adjuvant analgesic
- or inability to tolerate any adjuvant analgesic listed in protocol (eg. due to comorbidity, medication interaction or previous adverse effects)
- or inability to take oral medications (as determined by the treating clinician eg due to dysphagia)
- or expected poor absorption of oral medications (as determined by the treating clinician, eg due to vomiting)
- Stable regular adjuvant analgesics, opioids, antidepressants, anticonvulsants, benzodiazepines, paracetamol, non-steroidal anti-inflammatory drugs and steroids for 24 hours. Transdermal opioids must have had stable dosing for 48 hours due to the extended time to reach steady state. Short acting breakthrough opioid may be used as required.
Exclusion Criteria22
- Previous adverse reaction to lidocaine (lignocaine) or other amide-type local anaesthetics such as prilocaine, mepivacaine or bupivacaine
- Use of systemic lidocaine (lignocaine) infusion for analgesia within the four weeks prior to study entry at a dose greater than or equal to 1mg/kg/hr intravenous or subcutaneous
- Liver failure (Child class B or C, likely due to hepatic impairment)
- Renal failure (eGFR <15ml/min/1.73m2 )
- Cardiac comorbidity deemed a contraindication by the treating clinician including
- cardiac failure (New York Heart Association class II or greater within the past year
- heart block (first, second or third degree) at any time in the past ten years
- Stokes-Adams syndrome
- Cardiac abnormalities at time of screening
- bradycardia less than 60 beats per minute at rest whilst awake
- systolic blood pressure less than 100mmHg or greater than 160mmHg sitting
- unstable angina or myocardial ischemia
- atrial or supraventricular tachycardia greater than 100 beats per minute at rest
- Seizure episode within the past 4 weeks
- Cognitive impairment (MoCA<26)
- Fluctuating level of consciousness or delirium as determined by the treating team
- Acute porphyria
- Current use of the following medications
- propranolol, phenytoin, amiodarone, metoprolol, nadolol, St John’s Wort, donepezil, cimetidine, flecainide, fluvoxamine
- dihydroergotamine, vernakalant, saquinavir, dronedarone, amprenavir, lopinavir, propofol, arbutamine, atazanavir, succinylcholine, dasabuvir, paritaprevir, cobicistat, hyaluronidase, delavirdine, fosamprenavir, etravirine, ombitasvir, quinidine, disopyramide, procainamide, tocainide, mexiletine, propafenone, encainide, moricizine, bupropion, telaprevir, penbutolol, rapacuronium, nevirapine, nitrous oxide, cisatracurium, indinavir, ritonavir
- Participants who have participated in a clinical study of a new chemical entity within the four weeks prior to study entry
- Pregnant or breastfeeding
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Interventions
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.
Locations(3)
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ACTRN12617000747325