Clinical Trials

Multiple clinical trials have evaluated local anesthetic protocols associated with this compound class, specifically investigating completed Phase IV studies in spinal and regional anesthesia. Sponsored by academic medical centers such as University Hospital Ghent and Jinling Hospital China, these trials focused on optimizing minimum local anesthetic doses and efficacy parameters during surgical procedures. Overall, this late-stage clinical evaluation highlights efforts to refine regional and spinal anesthetic administration in ambulatory settings.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03805503 Completed
Spinal Anesthesia
University Hospital Ghent
 2015-09-16 Phase 4
NCT02287870 Completed
Anesthesia
Jinling Hospital China
 2008-01 Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Procaine HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Procaine binds to and inhibits voltage-gated sodium channels as well as NMDA, nicotinic acetylcholine, and 5-HT3 receptors, thereby blocking the influx of sodium ions across neuronal membranes. This inhibition prevents the generation and propagation of action potentials along peripheral nerve fibers, effectively interrupting pain signal transmission to produce localized and spinal anesthesia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.