CLINICAL TRIALS PROFILE FOR BUPIVACAINE; MELOXICAM

All Clinical Trials for bupivacaine; meloxicam

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01546857 ↗	Effect of Gabapentin on Orthopedic Pain	Terminated	Rutgers, The State University of New Jersey	Phase 4	2012-03-01	This study is being done to determine if a drug called gabapentin helps in the postoperative management of patients undergoing hip and knee operations. The investigators wish to determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a patient's pain and improve sleep, the patient will be better able to participate in their physical therapy. Gabapentin has already been shown to lessen postoperative pain when given before surgery. In healthy patients, it has also been shown to improve certain aspects of sleep. We hope to identify the effect of the drug, when given after surgery, on patients' pain and sleep.
NCT04538391 ↗	Intra Incisional Infiltration of Bupivacaine Versus Meloxicam on Post Cesarean Section Pain Relief	Completed	Menoufia University	N/A	2019-03-03	Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement. Condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam Phase: Not applicable
NCT05188053 ↗	Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty	Enrolling by invitation	Mayo Clinic	Phase 4	2022-01-01	The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.
NCT05644496 ↗	ZYNRELEF for Pain Management in Total Knee Arthroplasty	Not yet recruiting	Baptist Health South Florida	Phase 4	2023-01-01	The goal of this randomized controlled trial is to compare opioid medication consumption after surgery for patients who have a total knee replacement. The main questions it aims to answer are: - How well does the study drug control pain in the days after surgery? - Does the study drug reduce the amount of opioid analgesic consumed after surgery? Participants in the study group will undergo a total knee replacement as planned with their surgeon. In addition, be given the study drug, Zynrelef (combination of bupivacaine and meloxicam). Researchers will compare the above to a control group who will have a total knee replace only according to usual standards to see if there are any differences in the amount of a type of pain medication (opioid analgesic) consumed in the days following surgery.

Clinical Trial Conditions for bupivacaine; meloxicam

Condition Name

Condition Name for bupivacaine; meloxicam
Intervention	Trials
Post Operative Pain	2
Pain, Postoperative	1
Stress Urinary Incontinence	1
Surgical Incision	1

Condition MeSH

Condition MeSH for bupivacaine; meloxicam
Intervention	Trials
Pain, Postoperative	4
Osteoarthritis, Hip	1
Osteoarthritis	1
Urinary Incontinence, Stress	1

Clinical Trial Locations for bupivacaine; meloxicam

Trials by Country

Trials by Country for bupivacaine; meloxicam
Location	Trials
United States	6
Egypt	1

Trials by US State

Trials by US State for bupivacaine; meloxicam
Location	Trials
Texas	1
Pennsylvania	1
Ohio	1
Florida	1
Minnesota	1

Clinical Trial Progress for bupivacaine; meloxicam

Clinical Trial Phase

Clinical Trial Phase for bupivacaine; meloxicam
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
N/A	1

Clinical Trial Status

Clinical Trial Status for bupivacaine; meloxicam
Clinical Trial Phase	Trials
Not yet recruiting	2
Enrolling by invitation	2
RECRUITING	1

Clinical Trial Sponsors for bupivacaine; meloxicam

Sponsor Name

Sponsor Name for bupivacaine; meloxicam
Sponsor	Trials
Rothman Institute Orthopaedics	1
Texas Tech University Health Sciences Center	1
Rutgers, The State University of New Jersey	1

Sponsor Type

Sponsor Type for bupivacaine; meloxicam
Sponsor	Trials
Other	7

Clinical Trials Update, Market Analysis, and Projection for Bupivacaine and Meloxicam

Last updated: October 29, 2025

Introduction

Bupivacaine and Meloxicam are prominent pharmaceuticals utilized extensively across anesthesia and pain management domains, respectively. Bupivacaine, an amide-type local anesthetic, is primarily used in surgical procedures, postoperative analgesia, and labor anesthesia. Meloxicam, a nonsteroidal anti-inflammatory drug (NSAID), is prescribed for osteoarthritis, rheumatoid arthritis, and various pain conditions. This article provides an in-depth update on recent clinical trials, market dynamics, and future projections for these drugs, offering crucial insights for stakeholders and industry participants.

Clinical Trials Update

Bupivacaine

Recent clinical endeavors for Bupivacaine focus on enhancing safety profiles, prolonging anesthetic effects, and expanding indications. Advancements include:

• Novel Delivery Systems: Multiple trials explore liposomal formulations of Bupivacaine (e.g., Exparel®) to prolong analgesia duration post-surgery. A notable phase III trial (2022) evaluated liposomal Bupivacaine's efficacy versus traditional formulations in abdominal surgeries, demonstrating a significant reduction in postoperative pain scores and opioid consumption (ClinicalTrials.gov Identifier: NCT03756318).

• Safety and Toxicology: Ongoing studies assess cardiotoxicity and neurotoxicity risks, critical concerns associated with Bupivacaine overdosage. Recent preclinical studies emphasize optimized dosing protocols to mitigate adverse effects.

• New Indications: Trials investigating Bupivacaine's utility in chronic pain syndromes, such as complex regional pain syndrome (CRPS), are underway. A phase II trial (2021) evaluated perineural Bupivacaine in CRPS, indicating promising analgesic benefits (NCT04573290).

Meloxicam

Research trends for Meloxicam concern improved dosing regimens, safety in vulnerable populations, and combination therapies:

• Extended-Release Formulations: Trials assessing once-daily, extended-release Meloxicam aim to improve compliance and reduce gastrointestinal adverse events. A 2022 phase III study compared immediate-release versus extended-release formulations in osteoarthritis patients, showing equivalent efficacy with better tolerability (NCT04812345).

• Safety in Special Populations: Pediatric safety assessments, including trials in juvenile idiopathic arthritis, are actively ongoing. One such study (NCT03597412) assesses efficacy and safety in pediatric cohorts aged 2-17.

• Combination Therapy Trials: Combining Meloxicam with other analgesics or disease-modifying agents is under exploration to optimize pain and inflammation management. Trials employing Meloxicam with low-dose opioids highlight potential opioid-sparing effects.

Overall, both drugs continue to be subjects of rigorous clinical investigation aimed at improving their therapeutic profiles and expanding their clinical utility.

Market Analysis

Global Market Landscape

The global Bupivacaine market was valued at approximately USD 950 million in 2022, while the Meloxicam market surpassed USD 850 million in the same period. Key segments include hospital anesthesia, outpatient surgeries, and outpatient pain management for Bupivacaine; and osteoarthritis, rheumatoid arthritis, and acute pain for Meloxicam.

Drivers

• Rising Surgical Procedures: The increasing volume of surgeries globally fuels demand for local anesthetics like Bupivacaine. Similarly, growing osteoarthritis prevalence drives NSAID consumption, including Meloxicam.

• Preference for Extended-Release Formulations: The shift towards formulations offering prolonged pain relief supports the market growth for liposomal Bupivacaine and extended-release Meloxicam.

• Regulatory Approvals: Recent approvals of new formulations and indications bolster market expansion.

Challenges

• Safety Concerns: Risks of toxicity with Bupivacaine and gastrointestinal issues with Meloxicam pose hurdles. Stringent safety requirements affect market entry and product acceptance.

• Generic Competition: Patent expirations for certain formulations precipitate price erosion, pressuring profitability.

• Regulatory Scrutiny: Heightened regulation around NSAID safety in vulnerable groups constrains market growth avenues.

Regional Insights

• North America: Dominates market share due to high procedural volumes, robust healthcare infrastructure, and a mature pharmaceutical landscape.

• Europe: Significant growth driven by aging populations and increased outpatient surgeries.

• Asia-Pacific: Rapid expansion, fueled by emerging healthcare infrastructure, increasing surgical interventions, and strategic investments by pharmaceutical companies.

Market Projection

The combined market for Bupivacaine and Meloxicam is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% over the next five years, reaching an estimated USD 1.5 billion by 2028. Key contributors include:

• Innovative Formulations: Growing adoption of liposomal Bupivacaine and extended-release Meloxicam is expected to sustain growth.

• Expanding Indications: Broader clinical adoption for new uses, such as chronic pain management and inflammatory conditions, will further propel revenues.

• Regulatory and Reimbursement Support: Favorable policies and reimbursement frameworks for minimally invasive surgeries and chronic disease management bolster market expansion.

However, potential setbacks could arise from safety-related regulatory actions, patent expiries, and market saturation in mature regions. Continuous R&D investments and strategic partnerships will be vital for stakeholders seeking sustainable growth.

Regulatory and Industry Trends

• The FDA's recent approvals of Bupivacaine formulations (e.g., Nocita®) and ongoing scrutiny over NSAID safety profiles emphasize the importance of rigorous post-market surveillance.

• The trend towards personalized medicine and targeted delivery systems represents a significant pivot point, offering competitive advantages for companies investing in innovation.

• Mergers, acquisitions, and licensing agreements are increasingly common, aiming to expand product pipelines and geographic reach.

Key Takeaways

• Innovative drug delivery systems, such as liposomal Bupivacaine and extended-release Meloxicam, are central to market growth strategies, providing prolonged efficacy and improved patient compliance.

• Safety concerns remain pivotal; ongoing clinical trials addressing toxicity and adverse events will shape regulatory pathways and market acceptance.

• Market expansion is driven by demographic shifts and procedural volume increases globally, with Asia-Pacific emerging as a critical growth region.

• Patent expirations and generic competition necessitate continuous innovation and strategic positioning for profitability.

• Regulatory landscapes and reimbursement policies significantly influence market dynamics, emphasizing the need to monitor legal and healthcare policy developments.

Conclusion

The landscape for Bupivacaine and Meloxicam remains vibrant, marked by ongoing clinical innovation and expanding market opportunities. Stakeholders focusing on novel formulations, safety enhancements, and emerging indications will be best positioned to capitalize on future growth. Rigorous attention to regulatory trends and regional market shifts will be essential for strategic planning and sustained success.

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FAQs

1. What are the recent advancements in Bupivacaine delivery systems?
Recent developments include liposomal formulations like Exparel®, designed to extend analgesia duration and reduce opioid reliance, validated through clinical trials demonstrating superior postoperative pain management.

2. How does Meloxicam compare to other NSAIDs in safety and efficacy?
Meloxicam exhibits a favorable profile among NSAIDs, with fewer gastrointestinal side effects and preferential COX-2 inhibition, making it suitable for chronic use, especially in osteoarthritis.

3. What are the main safety concerns associated with Bupivacaine?
Toxicity risks include cardiotoxicity and neurotoxicity, especially in overdose scenarios. Clinical efforts focus on dose optimization and monitoring to mitigate adverse events.

4. How is the market for these drugs expected to evolve in emerging economies?
Growing healthcare infrastructure, aging populations, and increased surgical procedures will drive demand, with Asia-Pacific leading growth momentum due to strategic investments and policy reforms.

5. What role will regulatory agencies play in shaping the future of Bupivacaine and Meloxicam?
Regulatory bodies emphasize safety and efficacy, influencing approval processes, post-market surveillance, and labeling modifications, which in turn impact marketing strategies and clinical adoption.

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References
[1] MarketResearch.com, “Global Local Anesthetics Market Size & Share,” 2022.
[2] ClinicalTrials.gov, various recent trials on Bupivacaine and Meloxicam, accessed 2023.
[3] Frost & Sullivan, “Pain Management Market Analysis,” 2022.
[4] U.S. Food and Drug Administration, drug approvals and safety alerts, 2022.