Sustained Release Lidocaine for Treatment of Scrotal Pain
CompletedPhase 1, Phase 2NCT04026945
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Brief summary (from the registry)
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 formulation and is expected to provide pain relief over 4 weeks. Currently, the drug lidocaine is not available as an injectable slow-release formulation and chronic scrotal pain patients are often left untreated.
Study details
- Official title
- A Dose-Escalating Phase I Study of a Single Injection of Lidocaine Paste (ST-CP) for Spermatic Cord Block in Men With Chronic Scrotal Content Pain
- Conditions
- Interventions
- Sponsor
- University of British Columbia
- Start date
- 2019-10-31
- Primary completion
- 2021-03-24
- Sex
- Male
- Age range
- from 19 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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.
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| Department of Urologic Sciences, Gordon & Leslie Diamond Health Care Centre | Vancouver | British Columbia |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04026945