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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR NESACAINE


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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NCT03260972 ↗ Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control Withdrawn Johns Hopkins University Phase 3 2021-06-01 Objective The objective of this study is to test the hypothesis that instillation of intra-abdominal chloroprocaine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).
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for Nesacaine
Intervention Trials
Uterine Cervical Incompetence 1
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Clinical Trial Locations for Nesacaine

Trials by Country

Trials by Country for Nesacaine
Location Trials
United States 5
Canada 1
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Trials by US State

Trials by US State for Nesacaine
Location Trials
Arkansas 2
North Carolina 1
Oregon 1
New York 1
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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
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Clinical Trial Status

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Withdrawn 1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

Sponsor Name

Sponsor Name for Nesacaine
Sponsor Trials
University of Arkansas 2
Oregon Health and Science University 1
Duke University 1
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Sponsor Type

Sponsor Type for Nesacaine
Sponsor Trials
Other 8
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Nesacaine: Clinical Trials, Market Analysis, and Projections

Introduction to Nesacaine

Nesacaine, also known as 2-chloroprocaine, is a local anesthetic commonly used in various medical procedures, including epidural and spinal anesthesia. Here, we will delve into the clinical trials, market analysis, and future projections for Nesacaine.

Clinical Trials and Efficacy

Phase 2 and Phase 3 Studies

Clinical trials for Nesacaine, particularly those involving its derivative chloroprocaine, have shown promising results. For instance, a Phase 2 dose-finding study evaluated the safety, efficacy, and pharmacokinetics of chloroprocaine HCl in adult patients undergoing short-duration elective surgery. This study involved doses of 30, 40, and 50 mg and demonstrated the drug's efficacy and safety profile[1].

A subsequent Phase 3 non-inferiority study compared chloroprocaine 50 mg with bupivacaine 10 mg in patients undergoing elective short-duration lower abdominal surgery. The study supported the efficacy of chloroprocaine, although the primary endpoints were not the basis for the efficacy conclusions; instead, post hoc analysis of procedure success without rescue administration was used[1].

Safety and Toxicology

The safety of Nesacaine has been extensively evaluated. Repeat-dose toxicology studies in two species were conducted to support the New Drug Application (NDA) for an acute indication. These studies, including a seven-day repeat-dose rat study, characterized the toxicological potential of chloroprocaine, despite limitations in extending the study beyond seven days due to catheter patency issues[1].

Comparison with Other Anesthetics

A randomized double-blind study compared the clinical duration and efficacy of Nesacaine-MPF 2% and 3% solutions in peribulbar anesthesia for cataract surgery. The 3% solution provided a faster onset of surgical anesthesia and a longer duration of motor blockade compared to the 2% solution, although both concentrations were safe and effective[5].

Market Analysis

Global Market Size and Growth

The global local anesthesia drugs market, which includes Nesacaine, is projected to grow significantly. By 2030, the market is anticipated to reach USD 5.14 billion, growing at a Compound Annual Growth Rate (CAGR) of 3.6% from 2024 to 2030[2].

Market Segmentation

The market is segmented by drug type, with bupivacaine expected to hold the largest share by 2030 due to its prolonged duration of action and effectiveness in controlling post-operative pain. However, chloroprocaine, the active ingredient in Nesacaine, remains a significant player, especially in procedures requiring shorter duration anesthesia[3].

Mode of Administration

The injectable segment dominates the market, with widespread use in various surgical procedures. Surface anesthetics, however, are expected to grow rapidly due to advancements in drug delivery systems[2].

Regional Insights

North America holds the largest share in the local anesthesia drugs market, driven by the high number of surgical procedures performed in the region. Developing countries like India, Brazil, and China are also expected to contribute to market growth due to increasing healthcare spending and the number of surgeries performed[2].

Key Players and Competition

The local anesthesia drugs market includes several key players such as Aspen Pharmacare, Fresenius Kabi, Novartis, Inc., Sagent Pharmaceutical, Pacira Pharmaceutical, Mylan, and Teva Pharmaceuticals. These companies are continuously investing in research and development to improve the efficacy and safety of local anesthetics, including Nesacaine[2].

Future Projections

Market Growth Drivers

The growth of the local anesthesia drugs market, including Nesacaine, is driven by several factors:

  • Advancements in Drug Delivery Systems: Improvements in drug delivery systems are expected to enhance the efficiency and safety of local anesthetics.
  • Increasing Surgical Procedures: The rising number of surgical procedures globally, particularly in developing countries, will drive the demand for local anesthetics.
  • R&D Investments: Increased investments in healthcare and pharmaceutical research will lead to the development of more effective and safer local anesthetic medications[3].

Challenges and Opportunities

While Nesacaine faces competition from other local anesthetics like bupivacaine and lidocaine, its unique properties, such as rapid onset and shorter duration of action, present opportunities in specific clinical settings. The integration of AI technologies in clinical trials and the development of novel medications like levobupivacaine and ropivacaine will also influence the market dynamics[3].

Regulatory Considerations

Labeling and Indications

The labeling for Nesacaine and its derivatives must be precise, reflecting the specific clinical situations and patient populations for which the drug is approved. For instance, the FDA recommended approval for chloroprocaine 50 mg for the general indication of subarachnoid block (spinal anesthesia), with clear guidelines on the procedures studied and their durations[1].

Toxicology and Safety Data

Regulatory bodies require comprehensive toxicology studies to support any new drug application. For Nesacaine, these studies have been crucial in establishing its safety profile, particularly in relation to its systemic levels and metabolite exposure[1].

Key Takeaways

  • Clinical Efficacy: Nesacaine has demonstrated efficacy and safety in various clinical trials, including Phase 2 and Phase 3 studies.
  • Market Growth: The global local anesthesia drugs market is projected to grow at a CAGR of 3.6% from 2024 to 2030.
  • Market Segmentation: The injectable segment dominates, but surface anesthetics are expected to grow rapidly.
  • Regional Insights: North America leads the market, with growing contributions from developing countries.
  • Future Projections: Advancements in drug delivery systems, increasing surgical procedures, and R&D investments will drive market growth.

FAQs

What is Nesacaine used for?

Nesacaine, or 2-chloroprocaine, is used as a local anesthetic in various medical procedures, including epidural and spinal anesthesia.

How does Nesacaine compare to other local anesthetics?

Nesacaine has a faster onset and shorter duration of action compared to other local anesthetics like bupivacaine, making it suitable for specific clinical settings.

What are the key drivers of the local anesthesia drugs market?

The market is driven by advancements in drug delivery systems, increasing surgical procedures, and investments in healthcare and pharmaceutical research.

Which region dominates the local anesthesia drugs market?

North America holds the largest share in the local anesthesia drugs market due to the high number of surgical procedures performed in the region.

What are the regulatory considerations for Nesacaine?

Regulatory bodies require precise labeling, comprehensive toxicology studies, and clear guidelines on the procedures studied and their durations to support the safety and efficacy of Nesacaine.

Sources

  1. FDA Cross Discipline Team Leader Review: "208791Orig1s000 - accessdata.fda.gov"
  2. GlobeNewswire: "Local Anesthesia Drugs Market Size, Share & Trends Analysis Report 2024-2030"
  3. ResearchNester: "Local Anesthesia Drugs Market Size & Share, Growth Report 2037"
  4. GlobeNewswire: "Neurology Clinical Trials Market Size Is Expected To Reach a Revenue Of USD 9,231.1 Mn By 2033 at 5.8% CAGR"
  5. PubMed: "Randomized double-blind study of the clinical duration and efficacy of Nesacaine-MPF 2% and 3% solutions in peribulbar anesthesia for cataract surgery"

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