Status:
COMPLETED
Sustained Release Lidocaine for Treatment of Scrotal Pain
Lead Sponsor:
University of British Columbia
Conditions:
Chronic Pain
Eligibility:
MALE
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing chronic scrotal pain (CSCP). The new formulation ST-CP is a lidocaine sustained-release form...
Detailed Description
The purpose of this study is to find out if a new polymeric, water-free formulation of lidocaine is safe and can provide effective, long-lasting pain relief in chronic scrotal pain (CSCP) patients. Th...
Eligibility Criteria
Inclusion
- Adult ( ≥ 19 years) male
- Unilateral scrotal pain lasting \>3 months
- Average daily maximum scrotal pain score over 7 days ≥ 5 on the 0-10 NRS (see study protocol attached in 9.1.)
- Positive response to test spermatic cord block with 1% Lidocaine (Lidocaine HCl 1%, USP), defined as a temporary decrease of at least two points on the NRS (see study protocol attached in 9.1.) within an hour of injection
Exclusion
- Negative response to test spermatic cord block, defined as absence of a temporary decrease of at least two points on the NRS (see study protocol attached in 9.1.) within an hour of injection
- Other pain generator site with NRS ≥ 5
- History of allergic reaction to lidocaine or any other component of ST-CP Lidocaine
- Known hypersensitivity to anesthetics of the amide-type.
- Complete heart block.
- Use of anticoagulants (Aspirin permitted)
- Active infection involving the urinary tract or scrotum
- Inability to give consent
- Inability to follow up according to the protocol
- Negative response to previous spermatic cord block.
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04026945
Start Date
October 31 2019
End Date
March 24 2021
Last Update
October 13 2021
Active Locations (1)
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1
Department of Urologic Sciences, Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9