Clinical Trials
Multiple clinical trials evaluate bupivacaine hydrochloride across indications including postoperative pain, video-assisted thoracic surgery, mastectomies, lumbar spine surgery, and hip fractures managed with spinal anesthesia. Spanning Phase II through Phase IV as well as non-interventional evaluations, these predominantly not-yet-recruiting studies are sponsored by academic institutions—including the University of Utah, Naval Medical Center Portsmouth, and The University of Hong Kong—alongside industry partners like Pacira Pharmaceuticals Inc. Research protocols focus on local and regional anesthetic efficacy, examining techniques such as erector spinae plane peripheral catheter infusions and adductor canal blocks.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05038956 | Not yet recruiting | Video-assisted Thoracic Surgery (VATS) |
University of Utah |
2024-05-01 | -- |
| NCT06252662 | Not yet recruiting | Breast Cancer |
United States Naval Medical Center Portsmouth |
2024-04 | Phase 4 |
| NCT06350981 | Not yet recruiting | Back Pain|Surgery-Complications|Narcotic Use|Physical Stress|Post Operative Pain |
Foundation for Orthopaedic Research and Education|Pacira Pharmaceuticals Inc |
2024-04-01 | Phase 2|Phase 3 |
| NCT04003506 | Not yet recruiting | Pain Postoperative |
The University of Hong Kong |
2024-03-01 | Phase 4 |
| NCT06293404 | Not yet recruiting | Hip Fractures|Spinal Anesthesia |
Ankara City Hospital Bilkent |
2024-03-01 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
Mechanism and Biochemical Profile
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>).