CLINICAL TRIALS PROFILE FOR NESACAINE-MPF

All Clinical Trials for Nesacaine-mpf

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NCT03260972 ↗	Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control	Withdrawn	Johns Hopkins University	Phase 3	2021-06-01	Objective The objective of this study is to test the hypothesis that instillation of intra-abdominal chloroprocaine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.
NCT03805438 ↗	ED90 of 3% Chloroprocaine for Cervical Cerclage	Completed	University of Arkansas	Phase 4	2019-02-07	The aim of this study is to identify the dose of intrathecal (IT) chloroprocaine that provides effective anesthesia in 90% of patients undergoing elective cerclage placement (intraoperative analgesic supplementation not required).

Clinical Trial Conditions for Nesacaine-mpf

Condition Name

Condition Name for Nesacaine-mpf
Intervention	Trials
Spinal Anesthesia	1
Surgical Anesthesia, Cesarean Section	1
Adverse Reaction to Spinal Anesthetic	1
Cerclage, Cervical	1

Condition MeSH

Condition MeSH for Nesacaine-mpf
Intervention	Trials
Uterine Cervical Incompetence	1

Clinical Trial Locations for Nesacaine-mpf

Trials by Country

Trials by Country for Nesacaine-mpf
Location	Trials
United States	5
Canada	1

Trials by US State

Trials by US State for Nesacaine-mpf
Location	Trials
Arkansas	2
North Carolina	1
Oregon	1
New York	1

Clinical Trial Progress for Nesacaine-mpf

Clinical Trial Phase

Clinical Trial Phase for Nesacaine-mpf
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
N/A	1

Clinical Trial Status

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Withdrawn	1

Clinical Trial Sponsors for Nesacaine-mpf

Sponsor Name

Sponsor Name for Nesacaine-mpf
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-mpf
Sponsor	Trials
Other	8

Nesacaine-MPF: Clinical Trials, Market Analysis, and Projections

Introduction to Nesacaine-MPF

Nesacaine-MPF, a brand name for the local anesthetic chloroprocaine, is widely used in medical procedures for producing local anesthesia. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Purpose and Setting

Clinical trials have been conducted to evaluate the efficacy and safety of Nesacaine-MPF. A notable study compared the 2% and 3% concentrations of Nesacaine-MPF in patients undergoing peribulbar anesthesia for cataract surgery at the Tampa Eye and Specialty Surgery Center[1].

Methods and Results

This double-blind, randomized study involved 40 patients who received either 5 mL of Nesacaine-MPF 2% or 3% before surgery. The study assessed the time to onset of adequate motor blockade, the quality of surgical anesthesia, and the duration of motor blockade. The results showed that the 3% solution provided a faster onset of surgical anesthesia (mean 3.9 minutes vs 6.0 minutes) and a longer duration of clinical anesthesia, although it also required more time for recovery from anesthesia (98.9 minutes vs 84.8 minutes)[1].

Safety and Usage

Both concentrations of Nesacaine-MPF were found to be safe and effective, with no significant differences in adverse reactions. However, clinical studies did not include sufficient numbers of subjects 65 and over to determine if there are differences in responses between elderly and younger patients[4].

Market Analysis

Global Clinical Trials Market

The global clinical trials market, which includes trials for drugs like Nesacaine-MPF, is projected to grow significantly. Valued at USD 84.61 billion in 2024, it is expected to reach USD 146.60 billion by 2033, growing at a CAGR of 6.07% during the forecast period (2025–2033). This growth is driven by the increasing prevalence of chronic diseases and government initiatives supporting clinical trials[3].

Market Segmentation

The clinical trials market is segmented into different phases (Phase I to Phase IV) and types (interventional, observational, and expanded access). The interventional segment, which includes studies like those conducted for Nesacaine-MPF, is expected to dominate the market share during the forecast period. This is due to the high number of interventional studies, particularly in areas like autoimmune and inflammatory diseases[3].

Market Projections for Nesacaine-MPF

Demand and Usage

The demand for local anesthetics like Nesacaine-MPF is expected to rise due to the increasing number of surgical procedures. The drug's efficacy in providing rapid onset and effective anesthesia, as demonstrated in clinical trials, will likely contribute to its continued use in various medical settings.

Generic Availability

Nesacaine-MPF is available in generic forms, which can impact market dynamics. The generic availability of chloroprocaine hydrochloride solutions can make the drug more accessible and affordable, potentially increasing its market share[2].

Pricing

The pricing of Nesacaine-MPF and its generic counterparts can influence market projections. For instance, the cost of a 3% vial of Nesacaine-MPF is approximately $1.34 per mL, while the 2% vial costs around $1.28 per mL. These prices are provided for informational purposes and can vary based on market conditions[5].

Regulatory and Patent Status

FDA Approval and Patents

Nesacaine-MPF has been approved by the FDA in various formulations. The drug is manufactured by Fresenius Kabi USA, with approval dates dating back to 1996. Several patents related to Nesacaine-MPF are set to expire between 2026 and 2038, which could impact the market by allowing more generic versions to enter the market[2][5].

Key Takeaways

• Efficacy and Safety: Nesacaine-MPF has been shown to be safe and effective in clinical trials, with the 3% solution providing a faster onset and longer duration of anesthesia.
• Market Growth: The global clinical trials market, including those for Nesacaine-MPF, is projected to grow significantly due to increasing chronic diseases and government support.
• Generic Availability: The availability of generic forms of chloroprocaine hydrochloride can make the drug more accessible and affordable.
• Pricing and Regulatory Status: Pricing and patent expirations will continue to influence the market dynamics of Nesacaine-MPF.

FAQs

What is Nesacaine-MPF used for?

Nesacaine-MPF is used for producing local anesthesia by infiltration, peripheral nerve block, and central nerve block. It is commonly used in procedures such as cataract surgery and other surgical interventions[4].

How does the 3% solution of Nesacaine-MPF compare to the 2% solution?

The 3% solution of Nesacaine-MPF provides a faster onset of surgical anesthesia and a longer duration of clinical anesthesia compared to the 2% solution, although it also requires more time for recovery from anesthesia[1].

What are the potential side effects of Nesacaine-MPF?

The most commonly encountered adverse experiences are related to the central nervous system and the cardiovascular system. These adverse experiences are generally dose-related[4].

Is Nesacaine-MPF available in generic forms?

Yes, Nesacaine-MPF is available in generic forms of chloroprocaine hydrochloride, which can make the drug more accessible and affordable[2].

What is the projected growth of the clinical trials market?

The global clinical trials market is projected to grow from USD 91.50 billion in 2025 to USD 146.60 billion by 2033, at a CAGR of 6.07% during the forecast period[3].

Sources

1. Randomized double-blind study of the clinical duration and efficacy of Nesacaine-MPF 2% and 3% in peribulbar anesthesia for cataract surgery. PubMed.
2. Generic Nesacaine-MPF Availability. Drugs.com.
3. Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2033. Straits Research.
4. Nesacaine - accessdata.fda.gov. FDA.
5. Chloroprocaine: Uses, Interactions, Mechanism of Action - DrugBank. DrugBank.