None listed
Conditions
Brief summary
Intermittent infusions utilising lidocaine, magnesium or ketamine are routinely used in the management of neuropathic pain and fibromyalgia. These three treatments are utilised for treatment of the same condition without any current evidence to compare efficacy or to guide clinicians in the most appropriate therapy for a given patient. The current paradigm in the management of pain utilises multimodal analgesia, in which analgesics with different mechanisms of action are used in combination to harness presumed additive (and hopefully synergistic) effects and limit dose related adverse effects. However studies of analgesics are only infrequently examined in combination, which leads to a lack of information regarding the additive nature of any effects (positive or negative). Within the Sir Charles Gairdner Hospital (SCGH) Pain Management Department, patients are admitted as day stay patients for brief (1-2 hour) infusions of either lidocaine or ketamine, usually repeated on a weekly basis for a series of three infusions. The aim of this pilot study is to assess the efficacy and tolerability of an infusion utilising a combination of lidocaine, magnesium sulphate and ketamine in the treatment of neuropathic pain, CRPS and fibromyalgia. Data will be used to identify appropriate doses and guide the creation of a later comparative study. This study will be an open label pilot study. 30 patients with peripheral neuropathic pain, CRPS or fibromyalgia will be recruited from the Pain Management Department at SCGH. Patients will receive four intermittent infusions utilising a combination of lidocaine, magnesium sulphate and ketamine. Patients will be assessed for intra-infusion adverse effects and on a fortnightly basis for 6 weeks and then at 3 months following the final infusion. Data will be collected via phone interview as well as utilising the ePPOC questionnaire which includes multiple pain measures (BPI, DASS21, PSEQ,PCS, GRoC and medication usage) and is routinely used in the Pain Management Department at SCGH to assess efficacy of therapy. Following completion of the study, data obtained along with data from a prior audits of lidocaine and ketamine infusions for the treatment of neuropathic pain will be used to design a double blind comparative study.
Interventions
Patients will receive a series of 4 infusions given once weekly in the Pain Medicine Department at Sir Charles Gairdner Hospital. Each infusion will consist of a loading dose of 2mg/kg lidocaine, 0.25mg/kg ketamine and 25mg/kg MgSO4 administered over 20 minutes. This will be followed by a maintenance infusion of 2mg/kg/hr lidocaine, 0.25mg/kg/hr ketamine and 25mg/kg/hr MgSO4 for a further 3 hours. Patients will receive a total of 8mg/kg lidocaine, 1mg/kg ketamine and 100mg/kg MgSO4 over a period
Patients will receive a series of 4 infusions given once weekly in the Pain Medicine Department at Sir Charles Gairdner Hospital. Each infusion will consist of a loading dose of 2mg/kg lidocaine, 0.25mg/kg ketamine and 25mg/kg MgSO4 administered over 20 minutes. This will be followed by a maintenance infusion of 2mg/kg/hr lidocaine, 0.25mg/kg/hr ketamine and 25mg/kg/hr MgSO4 for a further 3 hours. Patients will receive a total of 8mg/kg lidocaine, 1mg/kg ketamine and 100mg/kg MgSO4 over a period of 200 minutes. As this is a pilot study the doses may be adjusted as required depending of development of adverse effects.
Sponsors
Daniel Ellyard
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age > 18 years Peripheral neuropathic pain (painful peripheral polyneuropathy, post herpetic neuralgia, trigeminal neuralgia, post surgical, post traumatic) OR Complex Regional Pain Syndrome (CRPS) OR Fibromyalgia Average pain intensity greater than or equal to 6/10 despite oral analgesic medications
Exclusion criteria
- Pregnancy or breastfeeding - History of seizure disorder -Conduction abnormality on 12 lead ECG – PR >200ms, QRS >120ms, QTc >440ms - Heart Failure – NYHA III / IV - Chronic Liver Impairment – albumin < 30g/L OR INR >1.3 - Chronic Renal Impairment - eGFR <60ml/min/1.73m2 - Cognitive impairment deemed sufficient enough to preclude informed consent - English language deemed insufficient to enable informed consent - Known allergy or intolerance of proposed study medications - Ongoing compensation/litigation claims
Outcome results
None listed