Clinical trial · Interventional
Subcutaneous Lidocaine For Cancer-Related Pain
A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion (SCLI) for Chronic Cancer-related Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study's primary objective is to test the hypothesis that a single infusion of subcutaneous lidocaine can cause a clinically useful reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. 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. We will use a composite endpoint of reduction in pain without increase in 24-hr opioid requirement or no decrease in pain with a ≥30% reduction in 24-hour opioid requirement.Subjects will receive either lidocaine or placebo, followed at least 1 week later by the alternate agent.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lidocaine | Drug | — | UNRESOLVED |
| Placebo (D5W) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lidocaine
- description
- Lidocaine
- interventionNames
- Drug: Lidocaine
- type
- PLACEBO_COMPARATOR
- label
- Placebo (D5W)
- description
- Placebo first as compared with lidocaine first
- interventionNames
- Drug: Placebo (D5W)
Primary outcomes (1)
- measure
- Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores
- timeFrame
- 7 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients 18 years of age or older * In or outpatients referred to the BCCA PSMPC Clinics with a diagnosis of cancer * Subjects must have somatic, visceral or neuropathic pain related to cancer * Pain intensity, measured by a worst pain score over the last 72 hours of ≥4 on a 0-10 numerical rating scale * Must have tried at least one opioid medication without adequate response or with significant side-effects for at least one week * For those with neuropathic pain, must have also tried at least one adjuvant analgesic, such as a tricyclic (unless contraindicated) or an anticonvulsant without adequate response or with significant side-effects for at least one week * Life expectancy of \> 3 months * Must be able to communicate symptoms indicating potential toxicity of Lidocaine * Must have a competent caregiver in the home overnight after each infusion * Must be willing to remain within 30 minutes of the Cancer Centre during each infusion Exclusion Criteria: * Clinically significant cardiac disease, i.e, cardiac failure, atrial fibrillation with slow ventricular rate (\<60), any degree of heart block * New analgesic treatment initiated in time frame which might have effect within one week of study drug. * Hyper or hypokalemia. * Liver failure (bilirubin ≥ 25 umol/L). * Renal failure (eGFR \<50% of normal) * Uncontrolled hypertension (\>160/90). * Hypotension (systolic \< 90). * Uncontrolled seizures. * Planned initiation of chemotherapy, radiotherapy or bisphosphonates within 30 days prior to treatment with study drug. * Received an investigational drug within 30 days prior to study. * History of allergy to lidocaine or other topical, local or infusional anesthetics.
References
Publications (0)
Data not yet available