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Last Updated: March 18, 2025

CLINICAL TRIALS PROFILE FOR EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE


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All Clinical Trials for epinephrine bitartrate; lidocaine hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT03672500 ↗ Perineal Local Infiltration Study Recruiting Sunnybrook Health Sciences Centre N/A 2018-09-14 The prevalence of birth canal lacerations is more than 70% of all deliveries in Canada. The repair of such lacerations is usually done using a pre-existing epidural analgesia. Once the analgesic effect of the epidural analgesia fades, the laceration may cause intolerable pain, and result in emotional stress, difficulties in ambulation and breastfeeding, and more. The research team hypothesis is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain, prevent such difficulties, and improve women's overall well-being and satisfaction. The proposed trial is a two-arm, single-masked, randomized trial. Women with a working epidural analgesia, and a laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get no injection. The differences in perineal pain between the groups will be evaluated at 6 hours after last epidural dose.
NCT02353676 ↗ Bupivacaine Supplementation For Postoperative Pain Control In Surgical Removal Of Mandibular Third Molars Unknown status Cosmozone Dental Clinic N/A 2015-01-01 Control of postoperative pain is a foremost goal in achieving a satisfactory postoperative recovery. Surgical removal of lower third molars is accompanied by postoperative pain that is at its peak in the first 12 hours. Our study evaluates if the use of 2% lidocaine hydrochloride for the surgical removal of lower third molars with a postoperative 0.5% bupivacaine supplementation would result in lesser postoperative pain and a decrease in ingestion of oral analgesics to control the pain when compared to a placebo.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for epinephrine bitartrate; lidocaine hydrochloride

Condition Name

2110-0.200.20.40.60.811.21.41.61.822.2Anesthesia, LocalEpisiotomy; ComplicationsSecond Degree Perineal Tear During Delivery - Delivered[disabled in preview]
Condition Name for epinephrine bitartrate; lidocaine hydrochloride
Intervention Trials
Anesthesia, Local 2
Episiotomy; Complications 1
Second Degree Perineal Tear During Delivery - Delivered 1
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Pain, Postoperative[disabled in preview]
Condition MeSH for epinephrine bitartrate; lidocaine hydrochloride
Intervention Trials
Pain, Postoperative 1
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Clinical Trial Locations for epinephrine bitartrate; lidocaine hydrochloride

Trials by Country

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Trials by Country for epinephrine bitartrate; lidocaine hydrochloride
Location Trials
Canada 1
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Clinical Trial Progress for epinephrine bitartrate; lidocaine hydrochloride

Clinical Trial Phase

100.0%0-0.200.20.40.60.811.21.41.61.822.2N/A[disabled in preview]
Clinical Trial Phase for epinephrine bitartrate; lidocaine hydrochloride
Clinical Trial Phase Trials
N/A 2
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Clinical Trial Status

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1RecruitingUnknown status[disabled in preview]
Clinical Trial Status for epinephrine bitartrate; lidocaine hydrochloride
Clinical Trial Phase Trials
Recruiting 1
Unknown status 1
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Clinical Trial Sponsors for epinephrine bitartrate; lidocaine hydrochloride

Sponsor Name

trials000001111111Sunnybrook Health Sciences CentreCosmozone Dental Clinic[disabled in preview]
Sponsor Name for epinephrine bitartrate; lidocaine hydrochloride
Sponsor Trials
Sunnybrook Health Sciences Centre 1
Cosmozone Dental Clinic 1
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2Other[disabled in preview]
Sponsor Type for epinephrine bitartrate; lidocaine hydrochloride
Sponsor Trials
Other 2
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Lidocaine Hydrochloride and Epinephrine Bitartrate: Clinical Trials, Market Analysis, and Projections

Introduction

Lidocaine hydrochloride combined with epinephrine bitartrate is a widely used local anesthetic solution, essential in various medical and surgical procedures. This article delves into the clinical trials, market analysis, and future projections of this drug combination.

Clinical Trials and Efficacy

Efficacy in Surgical Procedures

Clinical trials have consistently shown the efficacy of lidocaine hydrochloride with epinephrine bitartrate in surgical procedures. A study comparing 2% lidocaine with 1:80,000 and 1:200,000 epinephrine concentrations for the surgical extraction of impacted mandibular third molars found that both concentrations were equally effective in terms of pain management, but the 1:200,000 epinephrine concentration had better safety profiles regarding hemodynamic parameters[3].

Safety and Hemodynamic Effects

The same study highlighted that the use of 2% lidocaine with 1:200,000 epinephrine resulted in fewer changes in systolic blood pressure and heart rate compared to the 1:80,000 concentration, making it a safer option for patients with hemodynamic instability[3].

Comparative Studies

Another study comparing lidocaine 2% (Xylocain®) with etidocaine 1% (Duranest®) in patients undergoing retrobulbar anesthesia and facial nerve block found that lidocaine was more effective as an analgetic and kinetic agent during the initial period, while etidocaine had a longer analgesic effect[4].

Market Analysis

Market Size and Growth

The global lidocaine hydrochloride market, which includes formulations with epinephrine, is projected to grow significantly. In 2023, the market size was valued at USD 512.70 million and is anticipated to grow to USD 838.60 million by 2032, with a compound annual growth rate (CAGR) of 5.7% from 2024 to 2032[2].

Driving Factors

The growth of the lidocaine hydrochloride market is driven by several factors:

  • Increasing Surgical Procedures: The rise in the number of surgical, dental, cosmetic, and plastic surgeries globally is a significant driver. For instance, there was a 19% increase in cosmetic surgeries in the U.S. from 2019 to 2022[5].
  • Aging Population: The expanding elderly population, which requires more frequent medical and surgical interventions, contributes to the market growth[2][5].
  • Advancements in Drug Delivery: Innovations in drug delivery systems, such as transdermal patches and sustained-release formulations, have increased the market appeal of lidocaine hydrochloride products[5].

Regional Dominance

North America dominated the global lidocaine hydrochloride market in 2023, primarily due to the increasing geriatric population and the growing number of surgical procedures. The Asia-Pacific region is expected to be the fastest-growing market, driven by the aging population and increasing prevalence of conditions such as irregular heartbeats and cancer[2][5].

Distribution Channels

Retail pharmacies have emerged as the dominant distribution channels for lidocaine hydrochloride products, driven by growing awareness and accessibility of these products[2].

Market Challenges

Regulatory Scrutiny

Regulatory scrutiny is a significant challenge for the lidocaine hydrochloride market. Manufacturers must adhere to stringent safety standards and obtain thorough approvals, which can impede market growth[2].

Competition and Safety Concerns

The market faces intense competition from alternative pain management solutions. Additionally, the need for continuous research to address safety concerns and potential side effects adds complexity to market dynamics[2].

Future Projections

Market Growth

The lidocaine hydrochloride market is expected to continue growing, driven by the increasing demand for effective pain management solutions, especially in the aging population. The CAGR of 6.5% from 2024 to 2030 indicates a robust growth trajectory[5].

Technological Advancements

Advancements in drug delivery technologies will continue to play a crucial role in the market's growth. Innovations such as nebulized lidocaine, which showed promise in COVID-19 treatment by reducing cytokines and improving patient outcomes, will further expand the market's potential[5].

Segment Growth

Dental procedures will continue to hold the largest market share due to the widespread use of lidocaine hydrochloride in numbing affected areas. Other segments, including heart arrhythmia and epilepsy, will also contribute to the market's growth[5].

Key Takeaways

  • Clinical Efficacy: Lidocaine hydrochloride with epinephrine bitartrate is highly effective in surgical procedures, with the 1:200,000 epinephrine concentration offering better hemodynamic safety.
  • Market Growth: The global market is projected to grow significantly, driven by increasing surgical procedures, an aging population, and advancements in drug delivery technologies.
  • Regional Dominance: North America currently dominates the market, with the Asia-Pacific region expected to be the fastest-growing.
  • Challenges: Regulatory scrutiny, competition from alternative pain management solutions, and the need for continuous safety research are key challenges.
  • Future Projections: The market is expected to grow at a CAGR of 6.5% from 2024 to 2030, driven by technological advancements and increasing demand.

FAQs

Q: What are the common indications for Lidocaine Hydrochloride and Epinephrine Injection USP?

A: Lidocaine Hydrochloride and Epinephrine Injection USP is indicated for the production of local or regional anesthesia through infiltration techniques and peripheral nerve block techniques, such as brachial plexus and intercostal blocks[1].

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

A: Studies have shown that 2% lidocaine with 1:200,000 epinephrine has better safety profiles regarding hemodynamic parameters compared to 1:80,000 epinephrine concentration[3].

Q: What are the key drivers of the lidocaine hydrochloride market growth?

A: The market growth is driven by the increasing number of surgical procedures, an expanding elderly population, and advancements in drug delivery technologies[2][5].

Q: Which region dominates the global lidocaine hydrochloride market?

A: North America currently dominates the global market, with the Asia-Pacific region expected to be the fastest-growing[2][5].

Q: What are the challenges facing the lidocaine hydrochloride market?

A: Regulatory scrutiny, competition from alternative pain management solutions, and the need for continuous research to address safety concerns are significant challenges[2].

Sources

  1. Lidocaine Hydrochloride and Epinephrine Injection USP - Hikma Canada Limited.
  2. Lidocaine Hydrochloride Market Size, Share, Global Analysis Report - Polaris Market Research.
  3. Comparison of the efficacy and safety of 2% lidocaine HCl - PubMed.
  4. Epinephrine Bitartrate/Etidocaine Hydrochloride - Patsnap Synapse.
  5. Lidocaine Hydrochloride Market Size & Share Report, 2030 - Grand View Research.

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