CLINICAL TRIALS PROFILE FOR BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

All Clinical Trials for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

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.
NCT00486902 ↗	Does a Single Intravenous Dose of Ketamine Reduce the Need for Supplemental Opioids in Post-Cesarean Section Patients?	Completed	Northwestern University	N/A	2006-07-01	Pain control after cesarean delivery is associated with improved breastfeeding and infant rooming-in times. In addition, inadequate analgesia leads to elevated plasma catecholamine concentrations, which negatively affect every organ system. There is growing evidence that ketamine, N-methyl-D-aspartate receptor antagonist, is efficacious when used as an adjuvant in postoperative pain control. A 2006 Cochrane Collaboration systemic review and meta-analysis concluded, "Ketamine in subanesthetic doses….is effective in reducing morphine requirements in the first 24 hours after surgery." Ketamine's prolonged analgesic effect, despite its short half-life and its use in low doses, is theorized to be due to blockade of spinal cord central sensitization. Central sensitization is a phenomenon whereby repeated painful stimulus leads to more severe pain perception over time despite no change in the intensity of the painful stimulus.Ketamine may also prevent the development of acute opioid tolerance. Ketamine's analgesic effects have also demonstrated in the obstetric population. Post-cesarean delivery morphine requirements in women who received ketamine as part of a general anesthesia technique were decreased. Similary, low-dose ketamine in conjunction with bupivacaine-only spinal anesthesia reduced postoperative analgesic requirements compared to bupivacaine-only spinal anesthesia and bupivacaine-fentanyl spinal anesthesia. In the United States, healthy women scheduled for elective cesarean delivery commonly receive spinal anesthesia with bupivacaine-fentanyl-morphine. To our knowledge, IV ketamine has not been studied as an adjuvant to this regimen in the analgesic management in post-cesarean delivery patients. Multimodal therapy for postoperative pain control is widely practiced due to the advantage it provides in blocking multiple pain pathways while minimizing side effects of each individual pain medication. We hypothesize that low dose intravenous ketamine will improve multi-modal post-cesarean analgesia compared to placebo. The purpose of this study is to evaluate this hypothesis and study the possible side effects of this regimen in combination with bupivacaine-fentanyl-morphine spinal anesthesia.
NCT00635986 ↗	Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl	Completed	Federal University of São Paulo	N/A	2004-05-01	CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries. DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo. METHODS: 29 patients were divided into two groups. During the postoperative period, in the presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity was evaluated by numerical scale and plasma concentrations of Fentanyl were measured simultaneously.
NCT00452972 ↗	Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2004-04-01	This study was undertaken to compare the two techniques (exteriorized vs in situ) of uterine repair with respect to patient comfort, hemodynamic changes, surgical time and blood loss, in patients undergoing elective CD under a strictly standardized spinal anesthetic. We hypothesized that in situ uterine repair would be more comfortable for the patients.

Clinical Trial Conditions for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

Condition Name

Condition Name for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Intervention	Trials
Pain	7
Post Operative Pain	4
Pain, Postoperative	4
Hypotension	3

Condition MeSH

Condition MeSH for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Intervention	Trials
Pain, Postoperative	11
Hypotension	5
Vomiting	4
Nausea	4

Clinical Trial Locations for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

Trials by Country

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Trials by Country for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Location	Trials
United States	46
Canada	6
Egypt	4
Thailand	2
Saudi Arabia	2

Trials by US State

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−

Trials by US State for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Location	Trials
Pennsylvania	4
New York	4
California	4
Texas	3
Ohio	3

Clinical Trial Progress for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

Clinical Trial Phase

Clinical Trial Phase for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Clinical Trial Phase	Trials
Phase 4	30
Phase 3	1
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Clinical Trial Phase	Trials
Completed	28
Recruiting	10
Unknown status	8

Clinical Trial Sponsors for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

Sponsor Name

Sponsor Name for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Sponsor	Trials
University of Manitoba	4
Pacira Pharmaceuticals, Inc	4
University of Pennsylvania	2

Sponsor Type

Sponsor Type for BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Sponsor	Trials
Other	54
Industry	5

Bupivacaine Hydrochloride Preservative Free: Clinical Trials, Market Analysis, and Projections

Introduction

Bupivacaine hydrochloride, a local anesthetic, is widely used in various medical procedures to provide pain relief. This article delves into the recent clinical trials, market analysis, and future projections for preservative-free bupivacaine hydrochloride.

Clinical Trials and Efficacy

Intracameral Anesthesia

A randomized clinical trial compared the efficacy of preservative-free bupivacaine 0.5% and lidocaine 1.0% for intracameral anesthesia during phacoemulsification and posterior chamber intraocular lens implantation. The study found that bupivacaine 0.5% was as effective as lidocaine 1.0% in controlling patient discomfort during and after the surgery. However, in vitro studies revealed that bupivacaine 0.5% could cause significant corneal endothelial cell damage unless diluted with a balanced salt solution[1].

Extended Pain Relief Formulations

Virpax Pharmaceuticals conducted a maximum tolerated dose (MTD) study for Probudur, a liposomal formulation of bupivacaine, which is designed to provide both immediate and extended pain relief. The study indicated that Probudur was well-tolerated and had a better therapeutic window compared to free bupivacaine. The liposomal formulation reduced the toxicity associated with free bupivacaine, suggesting a safer and more effective option for pain management[3].

Comparison with EXPAREL

In clinical trials comparing EXPAREL (a long-acting local anesthetic) with bupivacaine HCl, EXPAREL demonstrated superior pain control and reduced opioid consumption in patients undergoing total knee arthroplasty and other surgical procedures. While bupivacaine HCl provided immediate pain relief, EXPAREL offered prolonged pain relief, highlighting the potential benefits of extended-release formulations[4].

Market Analysis

Global Market Size and Growth

The global bupivacaine injection market, which includes preservative-free formulations, is projected to grow significantly. As of 2017, the market size was USD 721.68 million, and it is expected to reach USD 1447 million by 2030, growing at a CAGR of 5.6% from 2020 to 2030. This growth is driven by an increasing older population with chronic diseases and the rise in various surgical procedures[5].

Market Segmentation

The bupivacaine injection market is segmented by type (0.25%, 0.5%, and 0.75%), end-user, and region. The 0.25% bupivacaine injection segment is expected to be the most profitable during the forecast period due to its widespread use in surgical, diagnostic, therapeutic, and obstetrical procedures[5].

Regional Dominance

North America is expected to dominate the global bupivacaine injection market due to the expanding patient population and the increase in medical and dental surgical procedures. The Asia-Pacific region is also expected to register high growth during the forecasted period[5].

Key Players and Market Dynamics

Major Players

The bupivacaine injection market is saturated with key players such as Pfizer, Baxter, Fresenius Kabi, and AstraZeneca. These companies play a significant role in the production, pricing, and distribution of bupivacaine hydrochloride injections[5].

Market Drivers and Restraints

The market is driven by the increasing demand for pain management solutions, especially in the context of rising surgical procedures and an aging population. However, factors such as the potential toxicity of bupivacaine and the need for careful dosing and administration could act as restraints[5].

Safety and Toxicity Considerations

Corneal Endothelial Damage

As noted in the clinical trial, bupivacaine 0.5% can cause significant corneal endothelial cell damage if not properly diluted. This highlights the importance of using balanced salt solutions to mitigate such risks[1].

Liposomal Formulations

The use of liposomal formulations, such as Probudur, has shown promise in reducing the toxicity associated with free bupivacaine. This could lead to safer and more effective pain management options[3].

Future Projections

Market Growth

The bupivacaine injection market is expected to continue growing, driven by increasing demand for effective pain management solutions. The forecast suggests a significant increase in market size by 2030[5].

Technological Advancements

Advancements in formulations, such as liposomal delivery systems, are expected to play a crucial role in the future of bupivacaine hydrochloride. These innovations could enhance the safety and efficacy of bupivacaine, further driving market growth[3].

Regulatory Considerations

Companies like Virpax Pharmaceuticals are moving towards filing Investigational New Drug Applications (INDs) for their proprietary formulations. Regulatory approvals will be critical in the widespread adoption of these new formulations[3].

Key Takeaways

• Efficacy: Preservative-free bupivacaine hydrochloride is effective for various medical procedures, including intracameral anesthesia and extended pain relief.
• Market Growth: The global bupivacaine injection market is projected to reach USD 1447 million by 2030, driven by increasing demand for pain management solutions.
• Safety: Proper dilution and formulation are crucial to mitigate the potential toxicity of bupivacaine hydrochloride.
• Innovations: Liposomal formulations and other technological advancements are expected to enhance the safety and efficacy of bupivacaine hydrochloride.

FAQs

What is the primary use of bupivacaine hydrochloride in medical procedures?

Bupivacaine hydrochloride is used as a local or regional anesthetic to numb a specific part of the body before, during, or after surgery, diagnostic procedures, therapeutic treatments, and obstetrical procedures.

How does the preservative-free formulation of bupivacaine hydrochloride impact its safety?

The preservative-free formulation reduces the risk of allergic reactions and other adverse effects associated with preservatives. However, it is crucial to follow proper dilution and administration guidelines to avoid toxicity, especially in sensitive tissues like the cornea.

What are the key drivers of the global bupivacaine injection market?

The market is driven by an increasing older population with chronic diseases, growth in various types of surgeries, and the rise in medical and dental surgical procedures.

How do liposomal formulations of bupivacaine hydrochloride improve its efficacy and safety?

Liposomal formulations, such as Probudur, provide both immediate and extended pain relief while reducing the toxicity associated with free bupivacaine. This results in a better therapeutic window and safer administration.

Which regions are expected to dominate the global bupivacaine injection market?

North America is expected to dominate the market due to the expanding patient population and the increase in medical and dental surgical procedures. The Asia-Pacific region is also expected to register high growth during the forecasted period.

Sources

1. Comparison of preservative-free bupivacaine vs. lidocaine for intracameral anesthesia: a randomized clinical trial and in vitro analysis. American Journal of Ophthalmology.
2. Bupivacaine Hcl Market Report 2024 (Global Edition). Cognitive Market Research.
3. Virpax Announces Results of Maximum Tolerated Dose Study for Probudur. Virpax Pharmaceuticals.
4. Proven reduction of pain and opioid use - EXPAREL. EXPAREL Pro.
5. Bupivacaine Injection Market to Reach USD 1447 Million by 2030. GlobeNewswire.