CLINICAL TRIALS PROFILE FOR BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

All Clinical Trials for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00298571 ↗	Cesarean Delivery and Post-operative Pain Management With Local Anesthesia	Completed	University of South Florida	Phase 2/Phase 3	2006-02-01	The use of .5% Bupivacaine with epinephrine at the time of skin closure in cesarean deliveries will decrease post-op pain.
NCT00458003 ↗	Phenylephrine in Spinal Anesthesia in Preeclamptic Patients	Completed	Northwestern University	N/A	2006-07-01	Hypotension remains a common clinical problem after induction of spinal anesthesia for cesarean delivery. Maternal hypotension has been associated with considerable morbidity (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been the vasopressor of choice because of concerns about phenylephrine's potential adverse effect on uterine blood flow. This practice was based on animal studies which showed that ephedrine maintained cardiac output and uterine blood flow, while direct acting vasoconstrictors, e.g., phenylephrine, decreased uteroplacental perfusion. However, several recent studies have demonstrated that phenylephrine has similar efficacy to ephedrine for preventing and treating hypotension and may be associated with a lower incidence of fetal acidosis. All of these studies have been performed in healthy patients undergoing elective cesarean delivery. Preeclampsia complicates 5-6% of all pregnancies and is a significant contributor to maternal and fetal morbidity and mortality. Many preeclamptic patients require cesarean delivery of the infant. These patients often have uteroplacental insufficiency. Given the potential for significant hypotension after spinal anesthesia and its effect on an already compromised fetus, prevention of (relative) hypotension in preeclamptic patients is important. Spinal anesthesia in preeclamptic patients has been shown to have no adverse neonatal outcomes as compared to epidural anesthesia when hypotension is treated adequately. Due to problems related to management of the difficult airway and coagulopathy, both of which are more common in preeclamptic women, spinal anesthesia may be the preferred regional anesthesia technique. Recent studies have demonstrated that preeclamptic patients may experience less hypotension after spinal anesthesia than their healthy counterparts. To our knowledge, phenylephrine for the treatment of spinal anesthesia-induced hypotension has not been studied in women with preeclampsia. The aim of our study is to compare intravenous infusion regimens of phenylephrine versus ephedrine for the treatment of spinal anesthesia induced hypotension in preeclamptic patients undergoing cesarean delivery. The primary outcome variable is umbilical artery pH.
NCT00519584 ↗	Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone	Terminated	The Cleveland Clinic	N/A	2007-07-01	This study will test the hypothesis that ropivacaine in combination with either systemic or local steroid provides comparably longer-lasting analgesia tha ropivacaine alone.
NCT00531349 ↗	Regional Anesthesia and Endometrial Cancer Recurrence	Withdrawn	The Cleveland Clinic	Phase 3	2007-11-01	The purpose of this study is to determine whether recurrence of local and metastatic cancer after open hysterectomy for stage 1 or 2 endometrial cancer is reduced when patients receive epidural anesthesia/analgesia combined with propofol sedation rather than sevoflurane anesthesia and opioid analgesia.
NCT00636415 ↗	Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis	Completed	Federal University of São Paulo	N/A	2004-06-01	CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of elderly people. The aim of the present study was to compare the analgesic effect of intra-articular bupivacaine and morphine in patients with knee osteoarthritis. DESIGN AND SETTING: A randomized and double-blind study was performed at a Pain Clinic of São Paulo Federal University. METHODS: Thirty-nine patients with pain for more than 3 months and an intensity higher than 3 on a numerical scale (zero to 10) were included. G1 patients received 1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and G2 patients received 25 mg (10 ml) 0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee flexion and extension angles were measured after administration of the drugs at rest and during movement. The total amount of analgesic complementation with 500 mg paracetamol was also determined.

Clinical Trial Conditions for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Condition Name

Condition Name for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Intervention	Trials
Postoperative Pain	23
Pain, Postoperative	22
Pain	16
Analgesia	10

Condition MeSH

Condition MeSH for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Intervention	Trials
Pain, Postoperative	58
Acute Pain	13
Osteoarthritis	10
Osteoarthritis, Knee	6

Clinical Trial Locations for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Trials by Country

Trials by Country for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Location	Trials
United States	99
Canada	23
Egypt	15
Brazil	6
Korea, Republic of	3

Trials by US State

Trials by US State for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Location	Trials
New York	11
Massachusetts	9
California	9
North Carolina	8
Texas	8

Clinical Trial Progress for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Clinical Trial Phase

Clinical Trial Phase for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	3
PHASE2	4

Clinical Trial Status

Clinical Trial Status for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Clinical Trial Phase	Trials
Completed	76
Recruiting	38
Not yet recruiting	24

Clinical Trial Sponsors for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Sponsor Name

Sponsor Name for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Sponsor	Trials
University of California, San Diego	6
Federal University of São Paulo	6
Wake Forest University Health Sciences	5

Sponsor Type

Sponsor Type for BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Sponsor	Trials
Other	216
Industry	10
U.S. Fed	6

Bupivacaine Hydrochloride and Epinephrine: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What is the product scope for “bupivacaine HCl and epinephrine”?

Bupivacaine hydrochloride and epinephrine is a locally acting anesthetic and vasoconstrictor combination used to prolong duration and reduce systemic absorption of bupivacaine. Epinephrine slows vascular uptake, which extends sensory block and reduces bleeding at the injection site.

Commercial and clinical use commonly centers on:

• Regional anesthesia (e.g., nerve blocks, epidural, local infiltration)
• Intraoperative local infiltration to reduce bleeding and extend analgesia
• Peri-procedural pain control where prolonged local effect is needed

This combination is widely marketed as injection formulations (typically fixed bupivacaine with epinephrine concentration ranges such as 1:200,000 or 1:100,000 depending on product), and most active-market brands are based on established, well-characterized public medicine.

What is the clinical trials landscape (current signal and trial structure)?

A full, up-to-date “clinical trials update” for this specific combination requires a current registry sweep across primary sources (e.g., ClinicalTrials.gov and EU CTR) and then mapping each study to the exact formulation (bupivacaine strength, epinephrine concentration, route, and comparator). That mapping step is essential because the combination is generic-level and trial postings often mix multiple local anesthetics, concentrations, and delivery methods.

Given the instruction constraints, no incomplete or non-auditable trial roster is provided here.

How trials typically enroll for this combination

Across local anesthetic combinations, trial designs most often fall into these buckets:

• Analgesia duration endpoints: time to two-segment regression, time to first rescue analgesia
• Block characteristics: onset time, duration of sensory vs motor block
• Safety endpoints: signs of local anesthetic systemic toxicity (LAST), cardiovascular parameters, neurologic adverse events
• Comparators: other local anesthetics, placebo saline, or different epinephrine concentrations, sometimes under the same procedural context

What to watch in new filings

For bupivacaine with epinephrine, new clinical signals usually come through:

• Different delivery platforms (e.g., ultrasound-guided techniques, catheter delivery schedules)
• Different dosage regimens (lower bupivacaine dose with epinephrine to maintain duration)
• Different indications (procedural pain control cohorts rather than anesthesia-only cohorts)

Because bupivacaine/epinephrine is mature, trial activity often trends toward dose optimization, comparative efficacy, and safety refinement rather than brand-new mechanism claims.

Where does this product sit in the market cycle?

Commercial maturity and competitive structure

Bupivacaine + epinephrine is in the late-life maturity of established anesthesia pharmacology. The competitive landscape is typically:

• Multi-brand or generic-sourced injection products with similar pharmacology
• Differentiation through presentation (concentration, vial sizes, labeling), supply chain, and institutional contracting
• Clinical differentiation often occurs via indication-specific claims and procedural protocols rather than novel active ingredients

Price and access dynamics

In mature local anesthetic combinations, pricing typically responds to:

• Generic penetration
• Institution formulary placement
• Volume contracting for hospital systems
• Tender cycles and local purchasing preferences

For investors and R&D planners, the key economic reality is that the value proposition often hinges on access, distribution, and protocol-level evidence more than incremental pharmacology.

What market segments drive demand?

Bupivacaine + epinephrine is demand-linked to procedure volume and anesthesia practice patterns. The most relevant demand segments are:

• Outpatient and ambulatory surgery (shorter length-of-stay drives preference for effective local/regional pain control)
• Orthopedics (local infiltration and regional anesthesia)
• General surgery and breast/soft tissue procedures (infiltration analgesia and reduced bleeding)
• Dental and maxillofacial settings (local anesthesia with prolonged effect)

Institutional protocols and surgeon/anesthesiologist practice patterns can shift share between formulations with different epinephrine concentrations, bupivacaine strengths, and injection volumes.

What are the regulatory and patent implications for R&D?

Patents and data exclusivity

For established anesthetic combinations, patent protection tends to be limited and may be centered on:

• Specific formulations (rare for this class unless a new composition or method is claimed)
• Methods of use tied to defined clinical protocols (often narrow and jurisdiction-specific)
• Manufacturing/process claims, if present for particular products

In practice, most commercial access is driven by:

• Generics and biosimilar-like substitution dynamics for small-molecule injectables
• Regulatory listing and interchangeability at the hospital and payer levels

Practical R&D target areas

If a developer is pursuing new economics, the realistic path is typically:

• Protocol-based differentiation (e.g., tailored dosing schedules for specific procedures)
• Safety and tolerability improvements via device-assisted delivery or infusion schemes
• Concentration/volume optimization supported by comparative trials

How should market projections be structured?

Because bupivacaine/epinephrine is a mature combination, robust projection work typically separates: 1) Procedure-volume growth (macro drivers) 2) Formulation and protocol share shifts (micro drivers) 3) Price erosion from generic competition (headwind) 4) Institution contracting cycles (lumpy timing)

A credible projection requires a base-year sales estimate by geography and segment, plus assumptions on:

• Hospital procedure volumes for relevant specialties
• Share of regional anesthesia and local infiltration
• Average selling price changes (generic erosion rate)
• Uptake of alternative local anesthetic strategies (e.g., different agents or adjuncts)

No numerical projections are provided here because they require current market sizing inputs.

What does a realistic forecast range depend on?

Without an auditable baseline for unit volumes, ASP, geography, and product share, any forecast would be non-specific. For this class of medicine, the forecast is most sensitive to:

• Generic pricing pressure and contract terms
• Shifts in anesthesia practice toward alternatives or technique-specific protocols
• Reimbursement and formulary policies at the health system level
• Safety communications and guideline updates that may change dosing behavior

Key takeaways

• Bupivacaine HCl plus epinephrine is an established regional anesthesia and local infiltration combination that extends block duration and reduces vascular uptake of bupivacaine.
• The clinical trials portfolio for mature local anesthetic combinations typically concentrates on dose optimization, technique comparisons, and endpoints tied to analgesia duration and safety.
• Market performance is primarily driven by procedure volumes, institutional protocol adoption, and generic pricing dynamics, not by mechanism innovation.
• A defensible market projection needs a current base-year sales and volume model; without auditable base inputs, numeric forecasts cannot be produced in a decision-grade format.

FAQs

1) Is bupivacaine HCl and epinephrine a single active mechanism or a combination strategy?

It is a combination strategy: bupivacaine provides local anesthetic effect while epinephrine reduces blood flow around the injection site to prolong local action and reduce systemic absorption.

2) What endpoints matter most in trials for this combination?

Trials most often track onset and duration of sensory block, time to rescue analgesia, and safety outcomes including signs consistent with LAST.

3) What differentiates one product from another in the market?

Differentiation is usually through concentration, presentation, packaging, and labeling for procedural indications, plus supply and contracting.

4) Why does generic entry matter more than clinical novelty?

In mature local anesthetic combinations, pharmacology is established and most incremental clinical benefit comes from protocol refinements that do not always translate into brand-level price premiums.

5) What drives procurement decisions for hospitals?

Procurement commonly responds to formulary status, contract pricing, vial sizing fit for commonly used dosing regimens, and clinicians’ procedural protocols.

---

References (APA)

[1] ClinicalTrials.gov. (n.d.). Bupivacaine hydrochloride and epinephrine search results. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drug approvals and labeling resources for local anesthetics. https://www.fda.gov/