CLINICAL TRIALS PROFILE FOR MARCAINE HYDROCHLORIDE

All Clinical Trials for Marcaine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00180687 ↗	Clinical Trial of the Use of Intraperitoneal Local Anaesthetic	Completed	Imperial College London	Phase 3	2004-10-01	Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control, one will have local anaesthetic and the third will have normal saline nebulised into their abdomen before closure of the wounds to reduce postoperative pain. These medications will be given on top of the standard pain management protocol.
NCT00472134 ↗	Laparoscopic Ventral Hernia Repair With Elastomeric Pain Pump	Completed	University Hospitals Cleveland Medical Center	N/A	2005-12-01	The purpose of this study is to determine the effects of a local anesthetic dispensed via a tiny catheter device, called the ON-Q PainBuster pump, placed during surgery on top of the mesh used in the laparoscopic repair of ventral hernias. The goals are: - reducing postoperative pain from this procedure - decreasing length of hospital stay - reducing or eliminating amount of post-operative narcotics used
NCT00508066 ↗	Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery	Completed	Shriners Hospitals for Children	Phase 4	2007-05-01	The purpose of this study is to evaluate the effects of continuous local anesthetic delivery on the immediate post-op recovery of patients undergoing spinal fusion surgery for congenital or idiopathic scoliosis.
NCT00508976 ↗	Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic	Completed	Pinnacle Health System	Phase 2	2007-06-01	The purpose of this study is to determine if pre-incisional lidocaine injection, instilled liquid bupivacaine, intra-abdominal aerosolized bupivacaine, or post-operative bupivacaine injection is superior in post-operative pain control in laparoscopic bariatric surgical patients.
NCT00532662 ↗	Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery	Unknown status	Tehran University of Medical Sciences	Phase 4	2007-11-01	Preemptive analgesia can improve postoperative pain management. Ketamine may prevent central sensitization during surgery and result in preemptive analgesia. The purpose of this study is to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have shown the involvement of N-methyl-D-Aspartate (NMDA) receptor in neuroplasticity.
NCT00533845 ↗	Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery	Completed	Maimonides Medical Center	Phase 4	2007-09-01	After Laparoscopic surgery most patients experience some form of mild to moderate pain. The current standard of care is to treat this pain with local anesthetics (numbing medication, that deadens the nerve endings) to the small surgical incisions (cuts) and narcotic systemic analgesics (medication injected into your vein to control pain such as morphine). Although this treatment improves pain symptoms it is not perfect. Firstly, complete pain control is rarely achieved and secondly, narcotics (such as morphine) often have many side effects including nausea, vomiting, sedation (sleepiness), constipation and abdominal upset. All of these issues make recovery less comfortable and delays return to full function (work, school and other activities of daily life). A new FDA approved device is now available that offers the benefits of long term anesthesia without the side effects of narcotics. It consists of a pump that continuously infuses local anesthesia into and around the surgical site. This pump is placed during your operation. You then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing medicine around your wounds for 2 days continuously. The purpose of this study is to see if this pump improves postoperative pain, decreases the need for narcotic pain medicine and allows people to return to their activities earlier.
NCT00574015 ↗	The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache	Completed	Albany Medical College	Phase 4	2007-12-01	This study will compare the degree of pain control provided by two techniques for persons with toothache in an emergency department. The two techniques include; - standard oral narcotic pain medication - numbing the tooth with local anesthetic by needle injection

Clinical Trial Conditions for Marcaine Hydrochloride

Condition Name

Condition Name for Marcaine Hydrochloride
Intervention	Trials
Pain, Postoperative	38
Pain	26
Postoperative Pain	26
Anesthesia, Local	10

Condition MeSH

Condition MeSH for Marcaine Hydrochloride
Intervention	Trials
Pain, Postoperative	93
Fractures, Bone	9
Hernia, Inguinal	8
Hernia	8

Clinical Trial Locations for Marcaine Hydrochloride

Trials by Country

Trials by Country for Marcaine Hydrochloride
Location	Trials
United States	161
Egypt	38
Turkey	19
Canada	17
Israel	6

Trials by US State

Trials by US State for Marcaine Hydrochloride
Location	Trials
California	20
New York	17
Illinois	13
Pennsylvania	10
Ohio	10

Clinical Trial Progress for Marcaine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Marcaine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	110
Phase 3	24
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Marcaine Hydrochloride
Clinical Trial Phase	Trials
Completed	139
Recruiting	51
Unknown status	32

Clinical Trial Sponsors for Marcaine Hydrochloride

Sponsor Name

Sponsor Name for Marcaine Hydrochloride
Sponsor	Trials
Istanbul University	12
Cairo University	12
Assiut University	8

Sponsor Type

Sponsor Type for Marcaine Hydrochloride
Sponsor	Trials
Other	337
Industry	18
U.S. Fed	2

Marcaine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Marcaine, also known as bupivacaine hydrochloride, is a local anesthetic widely used in various surgical and medical procedures to manage pain. This article provides an update on recent clinical trials, market analysis, and projections for this drug.

Clinical Trials Update

Efficacy of Liposomal Bupivacaine vs Bupivacaine Hydrochloride

A recent multicenter, randomized clinical trial compared the efficacy of liposomal bupivacaine combined with bupivacaine hydrochloride to bupivacaine hydrochloride alone in patients undergoing primary unilateral knee replacement surgery. The study, involving 533 participants, found that liposomal bupivacaine did not improve postoperative recovery or pain compared to bupivacaine hydrochloride alone[1].

Postsurgical Pain Management

Another study, a randomized, double-blind, placebo-controlled trial, evaluated the efficacy of INL-001 (a formulation containing bupivacaine) for postsurgical pain in patients undergoing abdominoplasty. While this study specifically looked at INL-001, it highlights the ongoing research into optimizing bupivacaine formulations for pain management. The study showed improvement in pain intensity and reduced opioid use in the treatment group compared to the placebo group[4].

Market Analysis

Current Market Size

The global market for bupivacaine hydrochloride was estimated to be worth US$ 251 million in 2023. This market is diverse, with several key players including Pfizer, Fresenius Kabi, Hikma Pharmaceuticals, and Baxter, among others[2][5].

Market Projections

The market is forecast to grow to US$ 361.9 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period of 2024-2030. This growth is driven by increasing demand for effective pain management solutions, particularly in regions with high rates of surgical procedures and an aging population[2][5].

Regional Market Dynamics

North America is projected to have the highest CAGR over the forecast period due to its technological advancements in healthcare, high rate of surgical procedures, and a competitive pharmaceutical market. The aging population in this region also contributes to the increased demand for chronic pain management solutions[5].

Key Players and Market Competition

The bupivacaine hydrochloride market is highly competitive, with both generic and brand-name manufacturers. Key players include:

• Hikma Pharmaceuticals
• Pfizer Inc.
• Fresenius Kabi AG
• Baxter International Inc.
• AstraZeneca
• AuroMedics Pharma LLC
• Shanghai Harvest Pharmaceutical Co.
• Southwest Pharma
• Hunan Kelun Pharmaceutical
• Aurobindo Pharma
• Sagent Pharmaceuticals[5].

Regulatory and Safety Considerations

Regulatory bodies like the FDA play a crucial role in ensuring the safety and efficacy of bupivacaine hydrochloride formulations. For instance, the FDA has reviewed extensive clinical safety data and pharmacokinetic studies to establish the safety profile of bupivacaine hydrochloride products, such as XARACOLL, which uses a similar mechanism to Marcaine[3].

Technological Advancements and Research Initiatives

The market is driven by continuous research and development initiatives aimed at improving the efficacy and safety of bupivacaine hydrochloride. Innovations such as liposomal formulations and new delivery systems are being explored to enhance the drug's performance and reduce side effects.

Market Trends and Growth Factors

Several factors contribute to the growth of the bupivacaine hydrochloride market:

• Increasing Surgical Procedures: The rise in elective and non-elective surgeries drives the demand for effective local anesthetics.
• Aging Population: An aging population increases the incidence of chronic pain conditions, further boosting demand.
• Technological Advancements: Improvements in drug delivery systems and formulations enhance the market.
• Competitive Landscape: Strong competition among pharmaceutical companies drives innovation and market growth[5].

Challenges and Limitations

Despite the growth prospects, the market faces challenges such as:

• Regulatory Hurdles: Strict regulatory requirements can delay market approval for new formulations.
• Side Effects and Safety Concerns: Bupivacaine hydrochloride, like other local anesthetics, can have side effects, which need to be carefully managed.
• Generic Competition: The presence of generic alternatives can impact the market share of brand-name products[2][5].

Key Takeaways

• The global bupivacaine hydrochloride market is expected to grow to US$ 361.9 million by 2030.
• Recent clinical trials have shown mixed results regarding the efficacy of new formulations.
• North America is a key region driving market growth due to its high rate of surgical procedures and aging population.
• The market is highly competitive with several key players.
• Regulatory and safety considerations are crucial for market approval and consumer trust.

FAQs

What is the current market size of bupivacaine hydrochloride?

The global market for bupivacaine hydrochloride was estimated to be worth US$ 251 million in 2023[2].

What is the projected growth rate of the bupivacaine hydrochloride market?

The market is forecast to grow at a CAGR of 5.4% from 2024 to 2030[2].

Which region is expected to have the highest CAGR for bupivacaine hydrochloride?

North America is projected to have the highest CAGR over the forecast period due to its technological advancements and high rate of surgical procedures[5].

What are the key factors driving the growth of the bupivacaine hydrochloride market?

Key factors include increasing surgical procedures, an aging population, technological advancements, and a competitive pharmaceutical market[5].

Who are the key players in the bupivacaine hydrochloride market?

Key players include Hikma Pharmaceuticals, Pfizer Inc., Fresenius Kabi AG, Baxter International Inc., and several others[5].

Sources

1. Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride ... - JAMA Surgery
2. Bupivacaine Hydrochloride - Market Size - Valuates Reports
3. 209511Orig1s000 - accessdata.fda.gov
4. A randomized, double-blind, placebo-controlled study to evaluate ... - Regional Anesthesia & Pain Medicine
5. Bupivacaine Hydrochloride Injection Market CAGR, size, share ... - Strategy Market Research Consulting