drugset / Trial / NCT05193227

Sustained Release Lidocaine for the Treatment of Postoperative Pain

NCT05193227

RandomizedParallel-groupSingle-blindTreatment

Summary

In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing postoperative pain after pelvic (circumcision, inguinal, scrotal), perineal (hemorrhoidectomy) or perianal (fistulotomy) incisions. The new formulation ST-01 is a sustained release lidocaine formulation and is expected to provide pain relief over multiple days. Currently, the drug lidocaine is not available as an injectable slow-release formulation.

Timeline

Start
2021-10-27
Primary completion
2026-04-27
Completion
2026-05-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 3 mg/kg Other
Subject Lidocaine Other / unclassified 4.5 mg/kg Other
Subject Lidocaine Other / unclassified 8 ml Other
Subject Lidocaine Other / unclassified 70 mg/ml Other

Indications

No indication recorded.