CLINICAL TRIALS PROFILE FOR ROPIVACAINE HYDROCHLORIDE

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	108
Postoperative Pain	88
Pain	69
Anesthesia, Local	29

Condition MeSH

Condition MeSH for Ropivacaine Hydrochloride
Intervention	Trials
Pain, Postoperative	253
Fractures, Bone	39
Osteoarthritis	34
Acute Pain	28

Clinical Trial Locations for Ropivacaine Hydrochloride

Trials by Country

Trials by Country for Ropivacaine Hydrochloride
Location	Trials
United States	258
France	78
China	73
Denmark	54
Canada	51

Trials by US State

Trials by US State for Ropivacaine Hydrochloride
Location	Trials
California	36
Pennsylvania	24
Ohio	24
Texas	18
Florida	17

Clinical Trial Progress for Ropivacaine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Ropivacaine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	359
Phase 3	101
Phase 2/Phase 3	19

Clinical Trial Status

Clinical Trial Status for Ropivacaine Hydrochloride
Clinical Trial Phase	Trials
Completed	407
Recruiting	127
Unknown status	110

Clinical Trial Sponsors for Ropivacaine Hydrochloride

Sponsor Name

Sponsor Name for Ropivacaine Hydrochloride
Sponsor	Trials
University of California, San Diego	18
Beijing Tiantan Hospital	15
Zealand University Hospital	14

Sponsor Type

Sponsor Type for Ropivacaine Hydrochloride
Sponsor	Trials
Other	1064
Industry	43
U.S. Fed	13

Ropivacaine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Ropivacaine Hydrochloride

Ropivacaine hydrochloride is a long-acting, amide-type local anesthetic widely used in various clinical settings, including surgical procedures, postoperative pain relief, and the management of chronic pain conditions. Here, we will delve into the recent clinical trials, market analysis, and future projections for this essential anesthetic agent.

Clinical Trials Update

Efficacy and Safety of CPL-01 (Ropivacaine Extended-Release Injection)

A recent Phase 2b clinical trial focused on CPL-01, an extended-release formulation of ropivacaine hydrochloride, has shown promising results. This study involved participants undergoing unilateral distal first metatarsal bunionectomy with osteotomy, who were randomized to receive either CPL-01, ropivacaine HCl, or a volume-matched placebo.

• Pain Management: Participants who received 300 mg of CPL-01 demonstrated lower mean Numeric Rating Scale (NRS) scores for pain with activity, indicating less pain compared to the placebo group. Additionally, these participants had numerically lower total opioid consumption[1].
• Safety and Pharmacokinetics: CPL-01 was found to be safe and well-tolerated, with no evidence of increased adverse events. The drug showed predictable and consistent extended-release pharmacokinetics, with no indication of "dose-dumping." This formulation delivered 38.5% of the ropivacaine dose in the first 24 hours, which is a significant improvement over traditional formulations[1].

General Clinical Use

In general clinical use, ropivacaine hydrochloride has been well-tolerated and effective. Studies have shown that it can be safely administered in various forms, including epidural infusions and local infiltrations, without serious adverse events. For example, continuous epidural infusion at rates up to 28 mg per hour for 72 hours has been well tolerated in adults[4].

Market Analysis

Market Size and Growth

The global ropivacaine hydrochloride preparation market is expected to witness significant growth. As of 2023, the market was valued at approximately USD 600 million and is projected to reach around USD 950 million by 2033, with a Compound Annual Growth Rate (CAGR) of 4.8% from 2024 to 2033[2].

Key Market Highlights

• Increasing Demand: The market is driven by the increasing demand for effective and well-tolerated local anesthetic and pain management solutions. Ropivacaine's favorable safety profile, including reduced potential for cardiovascular and central nervous system toxicity, is a key factor[2].
• Emerging Markets: The Asia-Pacific and Latin America regions present significant growth opportunities due to expanding healthcare infrastructure, rising prevalence of chronic pain conditions, and an increasing focus on improving patient outcomes[2].
• Regulatory and Supply Chain Challenges: Despite the growth potential, the market faces regulatory challenges, product quality issues, and competition from alternative local anesthetic and pain management therapies[2].

Regional Analysis

• North America: Traditionally the largest and most mature market, driven by a well-developed healthcare infrastructure and the presence of major pharmaceutical companies[2].
• Europe: Focuses on comprehensive, evidence-based solutions for pain management, with an emphasis on multimodal approaches and innovative drug delivery technologies[2].
• Asia-Pacific: Expected to experience the fastest growth, driven by the rising prevalence of chronic pain conditions, expanding healthcare infrastructure, and an increasing emphasis on improving patient outcomes[2].

Market Segmentation

Formulation

• Injectable Solutions: Commonly used for surgical anesthesia and postoperative pain management.
• Epidural Infusions: Used for continuous pain relief during and after surgery.
• Topical Preparations: Less common but used for localized pain management[2].

Application

• Surgical Anesthesia: Used to provide regional anesthesia during various surgical procedures.
• Postoperative Pain Management: Essential for reducing pain after surgery.
• Chronic Pain Management: Used in the long-term management of chronic pain conditions[2].

Future Outlook

Growth Opportunities

• Innovative Formulations: Ongoing research and development aimed at enhancing the performance, stability, and delivery of ropivacaine hydrochloride preparations. This includes the exploration of novel excipients, advanced coating technologies, and specialized drug delivery systems[2].
• Emerging Markets: The Asia-Pacific and Latin America regions are expected to drive significant growth due to their expanding healthcare infrastructure and rising demand for pain management solutions[2].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the ropivacaine market, with a significant decline in surgical procedures leading to decreased demand. However, as healthcare systems recover and surgical procedures increase, the demand for ropivacaine is expected to rise again[5].

Key Takeaways

• Clinical Efficacy: Ropivacaine hydrochloride, especially in extended-release formulations like CPL-01, has shown efficacy in reducing postoperative pain and opioid consumption.
• Market Growth: The global market is expected to grow at a CAGR of 4.8% from 2024 to 2033, driven by increasing demand and emerging markets.
• Safety Profile: Ropivacaine hydrochloride has a favorable safety profile, making it a preferred choice for pain management.
• Future Innovations: Ongoing research and development are expected to enhance the performance and delivery of ropivacaine hydrochloride preparations.

FAQs

What is the current market size of the ropivacaine hydrochloride preparation market?

The global ropivacaine hydrochloride preparation market was valued at approximately USD 600 million in 2023[2].

What is the projected growth rate of the ropivacaine hydrochloride preparation market?

The market is projected to grow at a CAGR of 4.8% from 2024 to 2033[2].

What are the key applications of ropivacaine hydrochloride?

Ropivacaine hydrochloride is used in surgical anesthesia, postoperative pain management, and chronic pain management[2].

How did the COVID-19 pandemic affect the ropivacaine market?

The pandemic led to a decline in surgical procedures, resulting in decreased demand for ropivacaine. However, demand is expected to rise as healthcare systems recover[5].

What are the emerging markets for ropivacaine hydrochloride preparations?

The Asia-Pacific and Latin America regions are expected to experience significant growth due to expanding healthcare infrastructure and rising demand for pain management solutions[2].

Sources

1. Efficacy, safety, and pharmacokinetics of CPL-01, an investigational ropivacaine extended-release injection, for postoperative analgesia after bunionectomy with osteotomy: a Phase 2b randomized clinical trial. PubMed, 2024.
2. Ropivacaine Hydrochloride Preparation Market Size, Share, Growth. Data Horizon Research, 2024.
3. General Anesthesia Drugs Market Size & Share Report, 2030. Grand View Research.
4. Ropivacaine Hydrochloride Injection | Baxter PI. Baxter PI, October 2023.
5. Ropivacaine Market Size, Industry Share | Forecast, 2032. Fortune Business Insights.