MARCAINE HYDROCHLORIDE W/ EPINEPHRINE (bupivacaine hydrochloride)
Marcaine (bupivacaine hydrochloride) is an amide local anesthetic indicated for the production of local or regional anesthesia or analgesia in adults undergoing surgical, dental, oral surgery, or diagnostic procedures, as well as obstetrical procedures. Specific concentrations and presentations are required depending on the type of block performed. Use is subject to specific limitations, as not all types of nerve blocks are indicated due to clinically significant risks associated with the drug.
How MARCAINE HYDROCHLORIDE W/ EPINEPHRINE Works
Bupivacaine blocks the generation and conduction of nerve impulses by increasing the threshold for electrical excitation, slowing the propagation of the impulse, and reducing the rate of rise of the action potential. This results in a predictable sequence of sensory and motor loss: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone. The addition of epinephrine acts as a vasoconstrictor, slowing the systemic absorption of bupivacaine to prolong the duration of the anesthetic effect in the target tissue.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1972-10-03
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE Approval History
What MARCAINE HYDROCHLORIDE W/ EPINEPHRINE Treats
2 indicationsMARCAINE HYDROCHLORIDE W/ EPINEPHRINE is approved for 2 conditions since its original approval in 1972. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anesthesia
- Analgesia
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE Boxed Warning
RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred afte...
WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of Bupivacaine Hydrochloride Injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary [see Warnings and Precautions (5.1) ]. WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning. There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of Bupivacaine Hydrochloride Injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary ( 5.1 ).
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
54 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07512635 | Ming-Yi-Yuan-Ethics-2024-54/02 | Ph 4 | not yet recruiting | Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Quality of Recovery in VATS Partial Pneumonectomy |
| NCT03854344 results posted | 143321 | Ph 4 | completed | Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain |
| NCT06077422 | Pro2022001580 | Ph 2, Ph 3 | enrolling by invitation | Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain |
| NCT06575699 | Pro00115981 | Ph 4 | completed | Rectus Sheath Block for Analgesia After Gynecological Laparotomy |
| NCT04928352 | 17300615 | Ph 3 | recruiting | Nebulized Bupivacaine Analgesia for Cleft Palate Repair |
| NCT05891613 | 21-007358 | Ph 4 | completed | A Study of Liposomal Bupivacaine Versus 0.25% Bupivacaine Hydrochloride Post Breast Reduction |
| NCT06799845 SPARK 2 | ATX-101-TKA-004 | Ph 2 | completed | Study Assessing Pain Relief After Replacement of the Knee |
| NCT06179004 Vs | 23-1116 | Ph 3 | recruiting | Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery |
| NCT04897841 OBLiBupi results posted | UPH-Meriter IRB 2021-005 A532860, SMPH/OBSTET & GYNECOL | Ph 4 | completed | Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control |
| NCT06577233 | H-55139 | Ph 4 | recruiting | Superior Hypogastric Nerve Plexus Block With Bupivacaine After Robotic Resection of Endometriosis |
| NCT06569953 | LBPB | Ph 4 | recruiting | Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial |
| NCT03360214 results posted | AAAQ4708 | Ph 4 | completed | PEMF and PEC Blocks in Mastectomy Reconstruction Patients |
| NCT06386770 | Asw.U./742 /2/23 | Ph 3 | recruiting | Systemic Versus Local Dexmedetomidine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block |
| NCT06502262 | MS 571/2023 | Ph 1 | completed | A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl As Additives to Bupivacaine in Pott's Fracture |
| NCT06146842 | 2023p003001 | Ph 4 | recruiting | ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL |
| NCT04260854 | STU00211424 | Ph 1 | enrolling by invitation | Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery |
| NCT05139030 results posted | 402-C-335 | Ph 3 | completed | Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty |
| NCT05303311 | 8035-7-11-2021 | Ph 4 | completed | Intrathecal Pethidine Plus Dexamethasone for Distal Lower Orthopedic Surgeries |
| NCT05133687 | MS-445-2021 | Ph 3 | completed | The Hemodynamic Effects of Different Volumes of Bupivacaine 0.25% Caudal Blocks in Pediatrics Undergoing Lower Abdominal Surgeries as Measured by Electrical Cardiometry |
| NCT03638960 | APP-18-01917 | Ph 4 | completed | Interscalene Single Shot With Plain Bupivacaine Versus Liposomal Bupivacaine for Arthroscopic Shoulder Surgery |
| NCT03789318 results posted | CA-PS-204 | Ph 2 | completed | Study in Subjects Undergoing Complete Abdominoplasty |
| NCT02892500 results posted | SanfordHealth | Ph 2 | terminated | Investigation of Corticosteroid Versus Placebo Injection in Patients With Syndesmotic Ligament Injury or High Ankle Sprain |
| NCT04727229 | 20-301 | Ph 4 | completed | Stellate Ganglion Block for Major Depressive Disorder. |
| NCT04293809 | 402-C-123 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation |
| NCT04826484 Baby ORIOLES results posted | IRB00284462 | Ph 3 | terminated | Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel |
| NCT06109415 | HTX-011-401 (Cohort 1) | Ph 4 | completed | A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. |
| NCT06109428 | HTX-011-401 (Cohort 2) | Ph 4 | completed | A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE |
| NCT05359731 | OAIC 1249/22 | Ph 4 | completed | Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade |
| NCT04766996 results posted | STUDY00002021 | Ph 4 | terminated | PROUD Study - Preventing Opioid Use Disorders |
| NCT05727098 | Erector block after mastectomy | Ph 2, Ph 3 | completed | Dexmedetomedine and Ketamine in Erector Spinae Block for Postoperative Analgesia Following Mastectomy. |
| NCT03702621 results posted | 1806187876 | Ph 3 | completed | Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery |
| NCT04778267 | MD-342-2020 | Ph 4 | completed | Effectiveness of Combined Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus Thoracic Paravertebral Block in Perioperative Pain in Modified Radical Mastectomy |
| NCT04613830 | 515 | Ph 3 | completed | Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients |
| NCT05502146 | 2022/05 | Ph 4 | completed | Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Maternal Hypotension |
| NCT03326180 SPAARK | OR16/88494 2016-003154-32, 197936 | Ph 3 | completed | Study of Peri-Articular Anaesthetic for Replacement of the Knee |
| NCT04814537 | 2020P003241 | Ph 4 | completed | Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques |
| NCT04518462 STRIDE results posted | 402-C-333 | Ph 3 | completed | Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries |
| NCT04368364 results posted | HSC-MS-20-0143 | Ph 4 | terminated | A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain |
| NCT04353414 | 20-00058 | Ph 4 | completed | Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection |
| NCT03885596 results posted | CA-PS-205 | Ph 2 | completed | Open-Label CA-008 (Vocacapsaicin) in Bunionectomy |
| NCT03907033 results posted | 15-008413 | Ph 4 | terminated | Liposomal Bupivacaine in Vaginal Hysterectomy |
| NCT03792906 | N71-2018 | Ph 4 | completed | Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery |
| NCT03270514 results posted | PRO17060305 | Ph 3 | completed | Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride |
| NCT03599089 results posted | CA-PS-201 | Ph 2 | completed | Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients |
| NCT03098420 results posted | F160421006 | Ph 2, Ph 3 | terminated | Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section |
| NCT03592537 | Fentanyl versus midazolam | Ph 2, Ph 3 | completed | Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children |
| NCT04173611 | 402-C-121 | Ph 1 | terminated | Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers |
| NCT03663283 results posted | 18-005366 | Ph 4 | completed | Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty |
| NCT03259243 | RAJLAPGYNE | Ph 4 | completed | Comparison of Efficacy of Bupivacaine for Relief Postoperative Pain in Women Undergoing Laparoscopic Gynecologic Surgery |
| NCT04244097 RCTcompstud | MS-273-2019 | Ph 2 | completed | The Effect of Intraperitoneal Bupivacaine Versus Bupivacaine With Neostigmine on Pain in Laparoscopic Cholecystectomy |
Showing 50 of 54 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE FDA Label Details
Indications & Usage
FDA Label (PDF)MARCAINE HYDROCHLORIDE W/ EPINEPHRINE is indicated for the treatment of Anesthesia; Analgesia.
WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride Injection for epidural anesthesia in obstetrical patients. In most cases, ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment