Ropivacaine HCl Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several clinical trials are evaluating ropivacaine hydrochloride across surgical and pain management indications, specifically targeting postoperative pain, bunion-related pain, and perioperative management in colorectal cancer surgery. Encompassing Phase 3, Phase 4, and unassigned phase classifications, these studies are sponsored by academic institutions and industry entities. Recruitment statuses across these investigations currently range from not yet recruiting to actively enrolling patients.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04003506	Not yet recruiting	Pain Postoperative	The University of Hong Kong	2024-03-01	Phase 4
NCT06006026	Recruiting	Colorectal Cancer	West China Hospital	2023-08-28	Not Applicable
NCT05773846	Recruiting	Bunion	PainReform LTD\|Lotus Clinical Research LLC	2023-03-13	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ropivacaine HCl selectively binds to voltage-gated sodium channels, reversibly inhibiting sodium ion influx across neuronal membranes and preventing action potential propagation along nerve fibers. This interruption of sensory nerve signal transmission produces localized anesthesia, providing effective regional pain management in postoperative clinical settings such as bunion operations and colorectal cancer surgeries.

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>).