CLINICAL TRIALS PROFILE FOR LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

All Clinical Trials for Lidocaine Hydrochloride And Epinephrine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001724 ↗	Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1997-11-01	This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
NCT00107822 ↗	Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Children	Completed	ZARS Pharma Inc.	Phase 3	2005-04-01	The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in children. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
NCT00107835 ↗	Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults	Completed	ZARS Pharma Inc.	Phase 3	2005-05-01	The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
NCT00154167 ↗	Safety and Efficacy Study of NV-101 in Dental Patients	Completed	Novalar Pharmaceuticals, Inc.	Phase 2	2003-02-01	The purpose of this study was: - to determine if NV-101 accelerates recovery from numbness compared to placebo - to evaluate safety of NV-101
NCT00194610 ↗	Botox as a Treatment for Interstitial Cystitis in Women	Completed	Paul G. Allen Family Foundation	Phase 4	2004-05-01	Patients with interstitial cystitis have been well documented to have pelvic floor muscle tenderness as well as pain on bladder distension. Some investigators have even suggested that pelvic floor muscle pain is primarily the cause of bladder problems. Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the neuromuscular junction. It has been shown that this mechanism relieves pain in a number of muscle spasm-related syndromes. Because, at present, there is little effective therapy available for patients with interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve bladder and pelvic pain in these patients.

Clinical Trial Conditions for Lidocaine Hydrochloride And Epinephrine

Condition Name

Condition Name for Lidocaine Hydrochloride And Epinephrine
Intervention	Trials
Pain	25
Anesthesia, Local	11
Pain, Postoperative	10
Anesthesia	9

Condition MeSH

Condition MeSH for Lidocaine Hydrochloride And Epinephrine
Intervention	Trials
Pain, Postoperative	27
Pulpitis	26
Acute Pain	10
Lacerations	8

Clinical Trial Locations for Lidocaine Hydrochloride And Epinephrine

Trials by Country

Trials by Country for Lidocaine Hydrochloride And Epinephrine
Location	Trials
United States	117
Canada	16
Egypt	9
Saudi Arabia	7
Germany	6

Trials by US State

Trials by US State for Lidocaine Hydrochloride And Epinephrine
Location	Trials
California	23
New York	10
Pennsylvania	9
North Carolina	7
Maryland	7

Clinical Trial Progress for Lidocaine Hydrochloride And Epinephrine

Clinical Trial Phase

Clinical Trial Phase for Lidocaine Hydrochloride And Epinephrine
Clinical Trial Phase	Trials
Phase 4	85
Phase 3	22
Phase 2/Phase 3	9

Clinical Trial Status

Clinical Trial Status for Lidocaine Hydrochloride And Epinephrine
Clinical Trial Phase	Trials
Completed	129
Not yet recruiting	27
Recruiting	26

Clinical Trial Sponsors for Lidocaine Hydrochloride And Epinephrine

Sponsor Name

Sponsor Name for Lidocaine Hydrochloride And Epinephrine
Sponsor	Trials
University of California, San Diego	6
University of North Carolina, Chapel Hill	5
University of California, San Francisco	4

Sponsor Type

Sponsor Type for Lidocaine Hydrochloride And Epinephrine
Sponsor	Trials
Other	263
Industry	28
U.S. Fed	8

Lidocaine Hydrochloride and Epinephrine: Clinical Trials, Market Analysis, and Projections

Introduction to Lidocaine Hydrochloride and Epinephrine

Lidocaine hydrochloride, often combined with epinephrine, is a widely used local anesthetic and vasoconstrictor. It is essential in various medical procedures, including surgical extractions, cosmetic surgeries, and pain management. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials: Efficacy and Safety

Recent clinical trials have focused on the efficacy and safety of lidocaine hydrochloride when combined with different concentrations of epinephrine. A notable study compared the efficacy and safety of 2% lidocaine with 1:80,000 or 1:200,000 epinephrine for surgical extraction of bilateral impacted teeth.

• Efficacy: The study found no statistically significant differences between the two groups in terms of medical efficacy. Both concentrations of epinephrine provided effective anesthesia for the surgical procedures[1].
• Safety: However, the study highlighted significant differences in hemodynamic parameters. The group receiving 2% lidocaine with 1:200,000 epinephrine showed better safety profiles regarding systolic blood pressure and heart rate compared to the group receiving 1:80,000 epinephrine. This indicates that the lower concentration of epinephrine may be safer in terms of hemodynamic stability[1].

Market Analysis

The lidocaine hydrochloride market is experiencing significant growth driven by several factors.

Market Size and Growth

• The global lidocaine hydrochloride market was valued at USD 512.70 million in 2023 and is anticipated to grow to USD 838.60 million by the end of the forecast period. This growth is projected at a Compound Annual Growth Rate (CAGR) of 4.1% by 2027[2][3].

Driving Factors

• Increasing Demand for Pain Management: The rising prevalence of chronic and acute pain conditions, along with the growing elderly population, is driving the demand for effective pain management solutions. Lidocaine hydrochloride, with its versatile formulations such as creams and injections, is well-positioned to meet this demand[2][3].
• Advancements in Drug Delivery Technologies: Innovations in drug delivery have enhanced the effectiveness and flexibility of lidocaine hydrochloride, contributing to its market growth[2].
• Surgical Procedures: The increase in the number of surgical procedures, including dental, cosmetic, and plastic surgeries, also boosts the demand for lidocaine hydrochloride[3].

Challenges and Restraints

• Regulatory Scrutiny: The market faces challenges from regulatory scrutiny, requiring strict adherence to safety standards and thorough approvals. Potential side effects associated with lidocaine hydrochloride also contribute to cautious adoption[2][3].
• Competition from Alternatives: Intense competition from alternative pain management solutions and the need for continuous research to address safety concerns add complexity to the market dynamics[2].

Market Projections

Future Growth

• The lidocaine hydrochloride market is expected to continue growing, driven by the increasing need for effective pain management solutions, especially among the aging population. The relaxation of strict regulations on surgical procedures post-pandemic and the resumption of services are also expected to drive demand[3].

Regional Analysis

• The market is primarily segmented based on dosage, application, distribution channel, and region. North America is a significant market due to its well-established infrastructure, technological advancements, and favorable reimbursement policies[2][3].

Role of Epinephrine in Lidocaine Hydrochloride

Epinephrine, when combined with lidocaine hydrochloride, serves as a vasoconstrictor, which helps in prolonging the anesthetic effect and reducing bleeding at the surgical site.

• Clinical Significance: The combination of lidocaine and epinephrine is crucial for achieving effective local anesthesia. Epinephrine's vasoconstrictive properties help in reducing systemic toxicity of lidocaine and enhancing its local anesthetic effect[4].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the lidocaine hydrochloride market.

• Potential Benefits: There was a proposed use of nebulized lidocaine as an adjunctive treatment for severe respiratory symptoms in COVID-19 patients, which temporarily boosted the market growth[3].

Key Takeaways

• Efficacy and Safety: Clinical trials indicate that lidocaine hydrochloride with different concentrations of epinephrine is effective, but the lower concentration of epinephrine (1:200,000) is safer in terms of hemodynamic stability.
• Market Growth: The lidocaine hydrochloride market is growing due to increasing demand for pain management, advancements in drug delivery technologies, and the rising number of surgical procedures.
• Challenges: Regulatory scrutiny, potential side effects, and competition from alternative solutions are key challenges.
• Future Projections: The market is expected to continue growing, driven by the aging population and the resumption of surgical procedures post-pandemic.

FAQs

What are the primary uses of lidocaine hydrochloride with epinephrine?

Lidocaine hydrochloride with epinephrine is primarily used for producing local or regional anesthesia through infiltration techniques, peripheral nerve blocks, and central neural blocks[4].

How does the concentration of epinephrine affect the safety of lidocaine hydrochloride?

A lower concentration of epinephrine (1:200,000) is associated with better safety profiles regarding hemodynamic parameters compared to a higher concentration (1:80,000)[1].

What are the driving factors for the growth of the lidocaine hydrochloride market?

The market is driven by the increasing demand for pain management, advancements in drug delivery technologies, and the rising number of surgical procedures, particularly among the aging population[2][3].

How did the COVID-19 pandemic impact the lidocaine hydrochloride market?

The pandemic led to a temporary increase in demand due to proposed uses of nebulized lidocaine for treating severe respiratory symptoms in COVID-19 patients[3].

What are the challenges facing the lidocaine hydrochloride market?

The market faces challenges from regulatory scrutiny, potential side effects, and competition from alternative pain management solutions[2][3].

Sources

1. Comparison of the efficacy and safety of 2% lidocaine HCl... - Medicine
2. Lidocaine Hydrochloride Market Size, Share, Global Analysis Report - Polaris Market Research
3. Lidocaine Hydrochloride Market - Share, Trends & Size - Mordor Intelligence
4. Lidocaine and Epinephrine Injection: Package Insert / Prescribing Info - Drugs.com
5. Epinephrine Market Size, Share | Segments | Forecast - 2033 - Allied Market Research

Last updated: 2025-01-07