Sustained Release Lidocaine for Treatment of Scrotal Pain (NCT04026945) | Clinical Trial Compass
CompletedPhase 1/2
Sustained Release Lidocaine for Treatment of Scrotal Pain
Canada12 participantsStarted 2019-10-31
Plain-language 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 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.
Who can participate
Age range19 Years
SexMALE
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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.