Sustained Release Lidocaine for Treatment of Scrotal Pain

• Status: Completed
• Trial end date: 2021-03-24
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Lidocaine

Criteria

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.