A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion (SCLI) for Chronic Cancer-related Pain
Ten mg/kg of lidocaine will be infused subcutaneously via a Baxter infusor over a 5.5 hour
period in ambulatory adult cancer patients with aworst pain score of at least 4 out of 10
despite therapy with at least one opioid plus appropriate oral adjuvant analgesic(s).
A clinically useful reduction in pain is defined by either a 2-point reduction (on a 0-10
scale) in the worst pain experienced over a 24-hour period, or a ≥30% reduction in 24-hour
opioid requirement.
The secondary objectives are 1) to determine whether any significant toxicities occur as a
result of the infusion. For this study significant toxicity is considered as any adverse
event which either leads to the infusion being terminated, or which leads to medical
intervention, such as prescribing of another medication or equivalent treatment, 2) to
determine the effect of Lidocaine infusion on QOL parameters as measured by the Patient
Outcome Scale (POS) Questionnaire and 3) to determine the duration of response to lidocaine
infusion.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Reduction in worst pain intensity or reduction in 24hr opioid dose of at least 30% without worsening of pain scores
The primary outcomes measure is a binary variable indicating whether lidocaine caused a reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. Lidocaine will be considered to have caused reduction in cancer pain if the subject had either one of the following episodes lasting a minimum of 7 days: A 2-point reduction in severity of pain as assessed by the worst pain score in the last 24 hours (question 3) of the Brief Pain Inventory - Short Form (BPI), compared to the BPI pain score at baseline. Or: ≥30% reduction in 24-hour opioid dose.
within 48 hours of infusion and lasting a minimum of 7 days
No
Philippa H Hawley, B.Med, FRCPC
Principal Investigator
British Columbia Cancer Agency
Canada: Health Canada
H10-00150
NCT01384877
December 2011
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