Liposomal Bupivacaine: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Liposomal Bupivacaine appears in the FDA drug-label database. Marketed as Bupivacaine.
- Drug class
- Amide Local Anesthetic (FDA established pharmacologic class)
FDA-approved use
. INDICATIONS AND USAGE Bupivacaine liposome injectable suspension is indicated to produce postsurgical: Local analgesia via infiltration in adults Regional analgesia via an interscalene brachial plexus nerve block in adults Limitations of Use The safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block. Bupivacaine liposome injectable suspension contains bupivacaine, an amide local anesthetic, and is indicated to produce postsurgical: Local analgesia via infiltration in adults ( 1 ). Regional analgesia via an interscalene brachial plexus nerve block in adults ( 1 ). Limitations of Use The safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block.
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. — Hospira Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2013-07-12 |
| cGMP deviations: Temperature abuse — Mckesson Medical-Surgical Inc. Corporate Office | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-04-13 |
| Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. — Hospira Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2014-04-21 |
| Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. — Hospira Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2013-07-12 |
| Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. — Hospira Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2014-02-10 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Breast Cancer | 1 |
| Duodenal Neoplasm | 1 |
| Osteoarthritis | 1 |
| Osteoarthritis, Knee | 1 |
| Pancreatic Neoplasm | 1 |
| Pancreatic cancer | 1 |
Recruiting trials involving Liposomal Bupivacaine
- Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty
- Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies
- Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
Common questions
Is Liposomal Bupivacaine FDA-approved?
Yes, marketed as Bupivacaine.
How many recruiting trials involve Liposomal Bupivacaine?
3 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.