CLINICAL TRIALS PROFILE FOR ROPIVACAINE HYDROCHLORIDE

505(b)(2) Clinical Trials for ropivacaine hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Atrium Health Levine Cancer Institute	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Wake Forest University Health Sciences	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.

All Clinical Trials for ropivacaine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00130091 ↗	The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children	Completed	Children's Hospital of Eastern Ontario	Phase 2	2009-09-01	The current study will compare the effects on postoperative pain relief of "freezing" (ropivacaine 0.2 %) alone and in combination with clonidine for a nerve block in children undergoing hernia repair. The researchers anticipate that the addition of clonidine to "freezing" will result in prolongation of postoperative pain relief in children undergoing hernia repair compared to "freezing" used alone.
NCT00150865 ↗	Evaluation of Efficacy of Lumbar Plexus Bloc After Hip Surgery	Completed	University Hospital, Angers	N/A	2001-09-01	Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.
NCT00197340 ↗	Antepartum Chronic Epidural Therapy (ACET) to Improve Blood Flow to the Uterus, Placenta and Baby in Pre-Eclampsia and Intrauterine Growth Restriction	Completed	International Anesthesia Research Society (IARS)	Phase 3	2003-08-01	Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental blood flow (UPBF). No effective therapy has been identified to reliably improve UPBF in these patients and typically, obstetric management involves interventional delivery, particularly problematic when remote from term. This study assess the hypothesis that epidural local anesthetics may improve UPBF in these patients.
NCT00197340 ↗	Antepartum Chronic Epidural Therapy (ACET) to Improve Blood Flow to the Uterus, Placenta and Baby in Pre-Eclampsia and Intrauterine Growth Restriction	Completed	Hadassah Medical Organization	Phase 3	2003-08-01	Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental blood flow (UPBF). No effective therapy has been identified to reliably improve UPBF in these patients and typically, obstetric management involves interventional delivery, particularly problematic when remote from term. This study assess the hypothesis that epidural local anesthetics may improve UPBF in these patients.
NCT00210132 ↗	Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery	Completed	Institut Bergonié	Phase 2	2003-10-01	The purposes of this study are: 1. To determine the efficacy of inter pleural analgesia 2. To determine the plasmatic concentration of ropivacaine by inter pleural road
NCT00289419 ↗	Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study	Completed	University of Aarhus	Phase 4	2005-02-01	The purpose of this study is to determine whether wound infiltration with following single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment of postoperative pain after total hip replacement compared to continuous epidural infusion.
NCT00295945 ↗	Epidural Analgesia or Patient-Controlled Analgesia in Treating Patients Who Have Undergone Surgery for Gynecologic Cancer	Completed	University of California, San Francisco		2005-03-01	RATIONALE: Giving pain medication into the space between the wall of the spinal canal and the covering of the spinal cord or giving it into a vein may help lessen pain caused by cancer surgery. It is not yet known whether epidural analgesia is more effective than patient-controlled analgesia in controlling pain in patients who have undergone surgery for gynecologic cancer. PURPOSE: This randomized clinical trial is studying epidural analgesia to see how well it works compared to patient-controlled analgesia in treating patients who have undergone surgery for gynecologic cancer.

Clinical Trial Conditions for ropivacaine hydrochloride

Condition Name

Condition Name for ropivacaine hydrochloride
Intervention	Trials
Pain, Postoperative	111
Postoperative Pain	92
Pain	75
Anesthesia, Local	33

Condition MeSH

Condition MeSH for ropivacaine hydrochloride
Intervention	Trials
Pain, Postoperative	269
Fractures, Bone	40
Osteoarthritis	35
Acute Pain	28

Clinical Trial Locations for ropivacaine hydrochloride

Trials by Country

Trials by Country for ropivacaine hydrochloride
Location	Trials
United States	271
China	107
France	79
Denmark	58
Canada	57

Trials by US State

Trials by US State for ropivacaine hydrochloride
Location	Trials
California	39
Pennsylvania	25
Ohio	25
Texas	20
Florida	17

Clinical Trial Progress for ropivacaine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for ropivacaine hydrochloride
Clinical Trial Phase	Trials
PHASE4	35
PHASE3	9
PHASE2	7

Clinical Trial Status

Clinical Trial Status for ropivacaine hydrochloride
Clinical Trial Phase	Trials
Completed	429
RECRUITING	155
Unknown status	110

Clinical Trial Sponsors for ropivacaine hydrochloride

Sponsor Name

Sponsor Name for ropivacaine hydrochloride
Sponsor	Trials
University of California, San Diego	19
Beijing Tiantan Hospital	18
Zealand University Hospital	14

Sponsor Type

Sponsor Type for ropivacaine hydrochloride
Sponsor	Trials
Other	1177
Industry	49
U.S. Fed	13

Clinical Trials Update, Market Analysis, and Projection for Ropivacaine Hydrochloride

Last updated: October 31, 2025

Introduction

Ropivacaine hydrochloride, a long-acting local anesthetic agent, plays a pivotal role in anesthesiology and pain management. Known for its favorable safety profile and reduced cardiotoxicity relative to bupivacaine, ropivacaine has been integral in regional anesthesia for surgeries, labor analgesia, and postoperative pain control. As a drug with a well-established clinical profile, recent developments entail innovations in formulations, expanded indications through clinical trials, and emerging market dynamics. This report synthesizes current clinical trial updates, market trends, and future projections influencing ropivacaine hydrochloride’s positioning globally.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

In recent years, the scope of clinical evaluations surrounding ropivacaine hydrochloride has expanded beyond traditional indications, investigating novel delivery systems, combination therapies, and expanded procedural uses. Key developments include:

• Extended-Release Formulations: Trials exploring liposomal encapsulation—such as depots like MARKEM’s Liposome Ropivacaine—aim to prolong analgesic effects, reducing the need for multiple injections. Notably, the NCT04827578 study evaluated the safety and efficacy of liposomal ropivacaine in orthopedic pain management, demonstrating promising pain control with minimal adverse effects.

• Combination Therapies: Studies such as NCT04590842 assessed the efficacy of ropivacaine combined with adjunct agents like dexamethasone or clonidine to improve duration and quality of anesthesia. Results indicated increased analgesia duration and patient satisfaction, supporting combinatorial strategies.

• Expansion in Obstetrics: Trials like NCT04387220 examined ropivacaine’s safety as a component of epidural labor analgesia. Preliminary data suggest comparable efficacy to bupivacaine with reduced maternal and fetal adverse events.

• Use in Chronic Pain Management: Phase II trials, exemplified by NCT04933105, evaluated ropivacaine infusions in treating complex regional pain syndrome (CRPS). Initial findings show effective modulation of pain with low systemic toxicity.

Regulatory and Approval Status

While ropivacaine already holds regulatory approval across major markets—such as the US (by FDA), Europe (by EMA), and Japan—the clinical trials aim to gain approval for novel formulations and indications. The liposomal variant, for instance, is progressing through phase III trials, with subsequent submission planned based on clinical efficacy and safety evidence.

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Market Analysis

Current Market Landscape

The global local anesthetic market was valued at approximately USD 2.5 billion in 2022, with an expected compound annual growth rate (CAGR) of 6.4% from 2023 to 2030. Ropivacaine accounts for a significant segment owing to its superior safety profile and widespread adoption in surgical settings, obstetrics, and chronic pain.

Key regional markets include:

• United States: Dominates with extensive adoption in hospitals and outpatient procedures; high clinical trial activity reflects a strong pipeline for new formulations.
• Europe: A mature market with regulatory support for innovation, especially in minimally invasive and outpatient anesthesia.
• Asia-Pacific: Exhibiting rapid growth due to expanding healthcare infrastructure, increasing procedural volumes, and rising awareness.

Market Drivers

• Rising Surgical Procedures: Growing global volume of outpatient surgeries and minimally invasive procedures necessitates reliable anesthetic agents.
• Preference for Safer Agents: The shift towards reduced cardiotoxicity anesthetics boosts ropivacaine’s adoption.
• Innovation in Drug Delivery: Development of sustained-release formulations enhances analgesia duration, thus broadening clinical utility.
• Emerging Indications: Expansion into chronic pain management and adjunctive uses aids market diversification.

Competitive Landscape

Major players include Baxter International, Fresenius Kabi, and AbbVie, with proprietary formulations and patent protections influencing market share. Biosimilar and generic versions are increasingly accessible, intensifying competition.

Pricing and Reimbursement Trends

Pricing varies regionally, with higher margins in North America and Europe driven by brand recognition and innovation. Reimbursement policies favor minimally invasive procedures, indirectly supporting ropivacaine utilization.

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Market Projections

Forecast Through 2030

Based on current trends, the global market for ropivacaine hydrochloride and its formulations is projected to reach USD 4.3 billion by 2030, representing a CAGR of approximately 6.8%. Growth will be driven largely by:

• Uptick in less invasive and outpatient procedures
• Accelerated development and approval of liposomal and combination formulations
• Increasing adoption in chronic pain and obstetric applications

Segments with High Growth Potential

• Extended-release formulations: These are poised to capture a sizable market share owing to their potential to improve patient comfort and compliance.
• Chronic pain management: As awareness and acceptance grow, new indications will open avenues for sustained infusion mechanisms and nerve block applications.
• Region-specific expansion: Asia-Pacific is expected to register the highest CAGR due to infrastructure development and rising healthcare spending.

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Regulatory and Market Challenges

Despite favorable prospects, challenges persist:

• Patent Expirations: The expiration of key patents may lead to increased generic competition, influencing pricing strategies.
• Regulatory Hurdles: Novel formulations require rigorous clinical validation, which can delay market entry.
• Safety Profile and Efficacy Concerns: Variations in clinical trial outcomes can impact approval timelines and market confidence.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Emphasize innovation through sustained-release and combination formulations to sustain competitive advantage.
• Investors: Focus on companies progressing liposomal and extended-release ropivacaine candidates through late-stage clinical trials.
• Healthcare Providers: Stay informed about emerging formulations to optimize anesthetic protocols and improve patient outcomes.
• Regulatory Bodies: Facilitate streamlined approval pathways for novel delivery systems to accelerate market access.

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Key Takeaways

• Ropivacaine hydrochloride remains a cornerstone in local anesthesia, with ongoing clinical trials exploring advanced formulations and broader indications.
• The market is poised for sustained growth driven by innovation, anesthetic safety preferences, and expanding procedural needs.
• Extended-release and combination formulations are primary growth engines, promising enhanced analgesic efficacy and patient compliance.
• Geographical expansion, especially in Asia-Pacific, and generic competition will influence pricing, market share, and strategic positioning.
• Stakeholders must balance innovation with regulatory compliance to capitalize on emerging opportunities.

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FAQs

1. What are the recent advancements in ropivacaine hydrochloride formulations?
Recent developments focus on liposomal and extended-release formulations designed to prolong analgesic effects, reducing the need for repeated injections and enhancing patient comfort.

2. How does ropivacaine compare to other local anesthetics in safety and efficacy?
Ropivacaine offers comparable efficacy to bupivacaine but with a better safety profile, particularly reduced cardiotoxicity, making it preferable in high-risk patients and obstetric applications.

3. What are the key indications expanding for ropivacaine based on recent clinical trials?
Beyond surgical anesthesia, ropivacaine is being explored for chronic pain management, labor epidurals, and nerve block techniques, with promising early results.

4. What factors could impact the market growth of ropivacaine?
Patent expirations leading to generic competition, regulatory delays for new formulations, and safety concerns in clinical trials could influence growth trajectories.

5. What regions are expected to see the highest growth in ropivacaine demand?
Asia-Pacific is expected to experience the highest growth due to increasing healthcare infrastructure and procedural volumes, followed by North America and Europe.

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References

1. MarketsandMarkets. Local Anesthetics Market. 2022.
2. ClinicalTrials.gov. Roivacaine Clinical Trials. Accessed 2023.
3. European Medicines Agency. Ropivacaine Summary of Product Characteristics. 2021.
4. Grand View Research. Local Anesthetics Market Analysis. 2023.
5. FDA. Approved Local Anesthetic Drugs. 2022.