Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01384877
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2011-06-27
Brief Title:
Subcutaneous Lidocaine For Cancer-Related Pain
Sponsor:
British Columbia Cancer Agency
Organization:
British Columbia Cancer Agency
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion SCLI for Chronic Cancer-related Pain
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This studys 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 requirementSubjects will receive either lidocaine or placebo followed at least 1 week later by the alternate agent
Detailed Description:
Ten mgkg of lidocaine will be infused subcutaneously via a Baxter infusor over a 55 hour period in ambulatory adult cancer patients with a worst pain score of at least 4 out of 10 despite therapy with at least one opioid plus appropriate oral adjuvant analgesics
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
Subjects will fill out Brief Pain Inventory BPI Patient Outcome Scale POS periodically and medication logs daily while on study
On Days of treatment the subjects will have vital sign monitoring every 15 minutes for the 1st hour and then periodically as set out in the protocol
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
Subjects will fill out Brief Pain Inventory BPI Patient Outcome Scale POS periodically and medication logs daily while on study
On Days of treatment the subjects will have vital sign monitoring every 15 minutes for the 1st hour and then periodically as set out in the protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None