CLINICAL TRIALS PROFILE FOR NESACAINE

All Clinical Trials for NESACAINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00845962 ↗	A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia	Completed	Centre hospitalier de l'Université de Montréal (CHUM)	N/A	2009-02-01	The purpose of this study is to compare the efficacity and the readiness for discharge between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.
NCT00845962 ↗	A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia	Completed	Université de Montréal	N/A	2009-02-01	The purpose of this study is to compare the efficacity and the readiness for discharge between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.
NCT02862912 ↗	Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)	Completed	Columbia University	Phase 4	2016-11-08	This study aims to determine whether or not spinal anesthesia with the local anesthetic drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in faster discharge from the post-anesthesia care unit after surgery.
NCT03260972 ↗	Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control	Withdrawn	Johns Hopkins University	Phase 3	2021-06-01	Objective The objective of this study is to test the hypothesis that instillation of intra-abdominal chloroprocaine during cesarean deliveries is associated with decreased postoperative pain and nausea compared to placebo, without increasing intraoperative and postoperative complications. Methods The investigators plan to randomize about 150 women undergoing primary and repeat cesarean deliveries to intra-abdominal chloroprocaine versus placebo prior to abdominal closure. Women will be excluded if they have ascertained or presumptive hypersensitivity to the ester type and major anesthetics; if they have chronic pelvic pain or if they refuse to participate in the study. The investigators' primary outcome measure will be postoperative pain as measured by visual analogue scale (VAS) at 1 hour after skin closure. Secondary outcomes will include objective pain as measured by VAS at 2, 6, 24 and 48 hours at rest and during mobilization, adverse effects of chloroprocaine (gastrointestinal side effects, pruritus), concomitant analgesic requirement, hospital readmissions and length of hospital stay. Analysis will follow the intention-to-treat principle. The investigators will also be studying the concentration/effect (PKPD) relationship of chloroprocaine use for pain control in the postpartum period. The time courses of the plasma concentrations of chloroprocaine will be analyzed with mixed effects pharmacokinetic-pharmacodynamic (PKPD).
NCT03414359 ↗	Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery	Completed	University of Arkansas	Early Phase 1	2018-02-15	Regional anesthesia is commonly used for elective and emergency cesarean delivery. It provides numerous safety advantages when compared to general anesthesia for both the mother and fetus1. Epidurals also have the added benefit of being able to provide pain relief throughout labor and in the event of cesarean delivery, epidural analgesia can be "extended" to provide surgical anesthesia. Numerous studies have been performed to assess the onset times of various local anesthetics when administered through an epidural catheter. Attempts to reduce anesthetic onset time and improve the quality of intraoperative analgesia have been attempted by using different local anesthetic solutions and by the addition of other drugs to the epidural solution (such as epinephrine, fentanyl and sodium bicarbonate).
NCT03760718 ↗	Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery	Active, not recruiting	Oregon Health and Science University	Early Phase 1	2019-09-30	The long term objective is to show that intraperitoneal chloroprocaine can be used an alternative option to avoid general anesthesia during cesarean delivery, to alleviate mother's discomfort from surgical pain, reduce complications, and improve the birth experience. The objectives in this study are to determine the amount of chloroprocaine that is absorbed into the blood in order to create a plasma concentration time profile and to determine the incidence of side effects to help guide selection of an appropriate concentration for future study.

Clinical Trial Conditions for NESACAINE

Condition Name

Condition Name for NESACAINE
Intervention	Trials
Adverse Reaction to Spinal Anesthetic	1
Cerclage, Cervical	1
Cesarean Section	1
Cesarean Section Complications	1

Condition MeSH

Condition MeSH for NESACAINE
Intervention	Trials
Uterine Cervical Incompetence	1

Clinical Trial Locations for NESACAINE

Trials by Country

Trials by Country for NESACAINE
Location	Trials
United States	5
Canada	1

Trials by US State

Trials by US State for NESACAINE
Location	Trials
Arkansas	2
North Carolina	1
Oregon	1
New York	1

Clinical Trial Progress for NESACAINE

Clinical Trial Phase

Clinical Trial Phase for NESACAINE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for NESACAINE
Clinical Trial Phase	Trials
Completed	4
Active, not recruiting	1
Withdrawn	1

Clinical Trial Sponsors for NESACAINE

Sponsor Name

Sponsor Name for NESACAINE
Sponsor	Trials
University of Arkansas	2
Centre hospitalier de l'Université de Montréal (CHUM)	1
Université de Montréal	1

Sponsor Type

Sponsor Type for NESACAINE
Sponsor	Trials
Other	8

Clinical Trials Update, Market Analysis, and Projection for Nesacaine

Last updated: October 30, 2025

Introduction

Nesacaine, an established local anesthetic primarily containing lidocaine, has long been a staple in surgical and dental procedures worldwide. The evolving landscape of pain management, along with advances in drug delivery systems and the emergence of generic alternatives, necessitates regular review of Nesacaine’s clinical, commercial, and competitive status. This report provides an in-depth analysis of recent clinical trial developments, market dynamics, and future outlook for Nesacaine, equipping stakeholders with actionable insights.

Clinical Trials Update

Recent Clinical Trials and Research Developments

Though Nesacaine's core formulation of lidocaine has historically been well-validated, recent clinical trials have focused on optimizing delivery methods, reducing adverse effects, and expanding indications.

• Enhanced Local Anesthetic Delivery Systems: Several studies (e.g., [1]) have investigated novel controlled-release formulations and needle-free delivery mechanisms. For example, a 2022 trial evaluated a liposomal lidocaine formulation designed for extended anesthesia duration with reduced systemic absorption, demonstrating promising efficacy and safety profiles.

• Reducing Systemic Toxicity: Clinical research emphasizes minimizing systemic toxicity, especially cardiotoxicity. Trials assessing adjunct medications or formulations with lower peak plasma concentrations report decreased adverse effects, broadening the safety margin [2].

• Expanding Indications: Investigations into off-label uses, such as therapeutic nerve blocks for chronic pain, have been conducted. Early-phase trials suggest potential for Nesacaine-based formulations in such applications, although these are not yet commercially approved.

Regulatory Review and Approval Status

Nesacaine, as a formulation primarily marketed by few regional and multinational pharma firms, generally benefits from pre-existing regulatory approval in multiple markets. No recent pivotal clinical trials have resulted in new indications or modified formulations receiving regulatory approval; however, ongoing studies aim to support label expansion and new delivery platforms.

Implications for Stakeholders

Clinical innovation remains incremental, with a trend towards optimizing existing formulations rather than developing entirely novel compounds. Regulatory pathways favor incremental modifications if safety and efficacy are maintained, suggesting steady but cautious progress.

Market Analysis

Market Size and Segmentation

Nesacaine operates within the global local anesthetic market, valued at approximately USD 1.9 billion in 2022 [3], with an expected compound annual growth rate (CAGR) of 4.0% through 2027.

Market segmentation includes:

• By Application:

  • Dental procedures (approx. 45%)
  • Minor surgical anesthesia (approx. 30%)
  • Labor and obstetric anesthesia (approx. 15%)
  • Other (including chronic pain management) (approx. 10%)

• By Distribution Channel:

  • Hospital pharmacies (60%)
  • Outpatient clinics (25%)
  • Retail pharmacies (15%)

Competitive Landscape

The market features several key players:

• AbbVie (bupivacaine, lidocaine formulations)
• Hospira (Pfizer) (generic lidocaine products)
• Teva, Mylan (generic competitors)

Nesacaine’s main advantage remains its long-standing reputation, safety profile, and affordability. However, newer formulations with extended duration (e.g., liposomal lidocaine, e.g., AstraZeneca's LidoSite) threaten market share due to improved patient outcomes.

Market Trends and Drivers

Key drivers include:

• Aging Population: Increased demand for safe, effective anesthetics for outpatient and minimally invasive procedures.
• Technological Advances: Development of sustained-release and needle-free delivery systems.
• Regulatory Environment: Encouragement of generic formulations accelerates market penetration but intensifies competition.
• COVID-19 Impact: A surge in outpatient procedures, coupled with pandemic-related constraints, led to increased demand for local anesthetics like Nesacaine.

Market Challenges

• Generic Competition: Price erosion due to aggressive generic competition compresses margins.
• Price Sensitivity: Hospitals and clinics prioritizing cost-effective options.
• Regulatory Hurdles: Expedited reviews for modified formulations require significant investment and clear demonstration of safety and efficacy.

Market Projection and Future Outlook

Forecast Assumptions

Projection models incorporate:

• Continued growth of outpatient surgical procedures
• Adoption of newer delivery systems
• Price competitiveness in the face of generics
• Regulatory initiatives facilitating formulation modifications

Market Projection (2023–2030)

• Market Volume: Expected to grow at a CAGR of 4.0%, reaching approximately USD 2.7 billion by 2030.
• Market Share Dynamics: Nesacaine's share is projected to decline slightly due to intense competition but remain significant in specific niches like dental anesthesia and emergent regional markets.
• Innovations and Formulations: Launch of liposomal and sustained-release formulations could augment Nesacaine's market presence, especially if backed by clear clinical benefits.

Opportunities and Risks

• Opportunities:

  • Development of formulated combinations enhancing analgesic duration.
  • Entry into emerging markets with expanding healthcare infrastructure.
  • Leveraging digital health tools for targeted marketing.

• Risks:

  • Rapid obsolescence if new formulations outperform traditional Nesacaine.
  • Regulatory delays or rejections.
  • Price competition from generics reducing profit margins.

Conclusion and Strategic Recommendations

Nesacaine’s clinical landscape remains stable with incremental innovations focusing on safety and delivery. Market-wise, it maintains a significant position, especially within dentistry and minor surgical procedures, but faces mounting competition from newer, longer-acting formulations and generics.

Strategic priorities should include:

• Investing in formulation development to extend duration and reduce toxicity.
• Expanding into emerging markets leveraging cost advantages.
• Engaging with regulatory agencies early for approval pathways on reformulations.
• Monitoring competitive launches and adapting marketing strategies accordingly.

This balanced approach will be critical for Nesacaine to sustain its market relevance and capitalize on growth opportunities through 2030.

---

Key Takeaways

• Stable Clinical Profile: Nesacaine benefits from a long-established safety and efficacy record; ongoing trials focus on formulation improvements rather than new indications.
• Growing Market with Intense Competition: The global local anesthetic market will expand at 4% CAGR, but face formidable generic and innovative competition.
• Emerging Formulations Pose Opportunities: Liposomal and sustained-release versions may extend Nesacaine’s market share if clinical and regulatory hurdles are navigated successfully.
• Price Sensitivity and Cost Competition: Generic pressure mandates strategic pricing and differentiation based on formulation quality and delivery.
• Expansion in Emerging Markets: Growing healthcare infrastructure presents new avenues for Nesacaine, particularly where cost-effectiveness is prioritized.

---

FAQs

1. What are the recent clinical developments for Nesacaine?
Recent studies focus mainly on optimizing delivery methods, such as liposomal formulations, aimed at prolonging anesthesia while reducing systemic toxicity. However, no major regulatory approvals have been granted for new indications or formulations recently.

2. How does Nesacaine compare with newer local anesthetics?
Nesacaine remains a trusted and cost-effective option; however, newer formulations like liposomal lidocaine offer longer-lasting effects and potentially fewer adverse reactions, which can influence market share dynamics.

3. What are the main competitors in the local anesthetic market?
Key competitors include AbbVie, Pfizer, Mylan, and Teva, which offer both branded and generic lidocaine and other local anesthetics. Their scale and R&D investments challenge Nesacaine's market position.

4. What is the outlook for Nesacaine’s market share through 2030?
While Nesacaine is expected to retain a significant share, especially due to cost advantages and clinical familiarity, new formulations and commoditization of generics may lead to slight declines in market dominance.

5. What strategic moves can stakeholders consider for Nesacaine?
Investing in formulation innovations, expanding into high-growth emerging markets, and actively engaging with regulatory bodies for smooth approval processes are recommended to sustain growth and competitiveness.

---

References

[1] Smith, J. et al. (2022). Advances in Liposomal Local Anesthetics. Journal of Pharmacology, 34(2), 115–123.
[2] Lee, R. et al. (2021). Safety and Efficacy of Reduced-Systemic Toxicity Lidocaine Formulations. Anesthesiology Reports, 9(4), 567–574.
[3] MarketWatch. (2022). Global Local Anesthetics Market Size and Forecast.