CLINICAL TRIALS PROFILE FOR XYLOCAINE

All Clinical Trials for Xylocaine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00014040 ↗	Nitric Oxide Inhalation Therapy to Relieve Chest Pain in Patients With Coronary Artery Disease	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2001-04-01	This study will test whether inhaling nitric oxide gas can improve blood flow to the heart, ventricular function, exercise tolerance in patients with coronary artery disease and chest pain that has not improved with medical or surgical therapy. Patients with coronary artery disease who have chest pain despite treatment with medicines and angioplasty or surgery may be eligible for this study. Those enrolled will receive monetary compensation for their participation in this study. The duration of the study is 5 days, with 2 testing periods lasting 2 days each. During one of the periods, the study participants will breathe nitric oxide mixed with room air through a face mask during the tests. During the other period, the participants will breathe room air alone through a face mask during the tests. At least 1 day will separate the treatment periods. During each of the 2 treatment periods (nitric oxide and room air), participants will undergo 4 tests to determine whether the treatment improves the heart's response to stress with increased heart rate and contraction. Approximately one hour before each of the tests, participants will breathe either nitric oxide mixed with room air or room air alone through the face mask, and continue the inhalation treatment while each test is being performed. The face mask will be removed at the end of each test. On the morning of the first day of each treatment period, participants will have a special echocardiogram with imaging of the heart. The echocardiogram will be performed during an infusion of dobutamine, a medicine that increases heart rate and contraction, and serves to stress the heart. This manner of stress testing is commonly used in hospitals around the country to determine if walls of the heart are receiving sufficient blood supply. That afternoon, participants will undergo a magnetic resonance imaging (MRI) study of the heart. The MRI will determine the heart's blood flow and contraction while receiving the same dosage of dobutamine as was used earlier in the day. On the morning of the second day of each treatment period, participants will exercise on a treadmill until moderately uncomfortable chest pain is reported. Later that morning, participants will undergo cardiac catheterization. For the cardiac catheterization, a long tube (catheter) will be placed into a vein of the neck once the skin is numbed with xylocaine. This tube will be positioned within the right atrium of the heart and into a tube-like structure called the coronary sinus, where venous blood exits the heart muscle. A small catheter will also be placed in an artery of the upper forearm after the skin has been numbed with xylocaine. Blood samples will be taken to allow us to measure the amount of nitric oxide transported in the blood. The blood samples will be drawn (through the tube in the heart and through the small tube in the artery) at the beginning of the study and during infusion of dobutamine to stress the heart. The dose of the dobutamine infusion will be the same dose used in the previous day's stress studies. After the completion of the first treatment period, we will stop testing for at least one day. Participants will begin the second treatment period with the inhalation treatment not received during the first treatment period.
NCT00219713 ↗	Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.	Terminated	Air Liquide Santé International	Phase 3	2000-03-01	Bone marrow biopsy is a painful medical procedure often performed with local anesthetic. Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal ruler
NCT00219713 ↗	Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.	Terminated	Ministry of Health, France	Phase 3	2000-03-01	Bone marrow biopsy is a painful medical procedure often performed with local anesthetic. Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal ruler
NCT00219713 ↗	Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.	Terminated	Poitiers University Hospital	Phase 3	2000-03-01	Bone marrow biopsy is a painful medical procedure often performed with local anesthetic. Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal ruler
NCT00456872 ↗	Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies	Completed	Ohio State University Comprehensive Cancer Center	N/A	2004-12-01	Oncology patients require numerous invasive procedures throughout their disease process including bone marrow biopsies (BMB). BMB.s are performed by a significant number of health care providers. One of the biggest concerns for health care providers is to improve patient comfort. The goal of this study was to reduce pain during BMBs. Specific aims of the study were to determine if there is a difference in patients' perceived pain during injection of the pre-procedure anesthetic when buffered versus unbuffered lidocaine is administered to patient's receiving bone marrow biopsies. A double blind, experimental crossover design was used to examine the difference in pain levels when using buffered versus unbuffered lidocaine prior to the bilateral bone marrow biopsy procedure. Based on a power analysis for a paired t-test, a convenience sample of 48 patients was enrolled into the study. Patients served as their own control. The site of first biopsy, and which lidocaine solution was administered first, were randomized. A 100mm visual analogue scale (VAS) was used to measure pain. All data has been collected, are currently under analysis, and results will be completed in August 2006. Differences in groups will be examined using a paired t-test. A demographic questionnaire was used to gather select demographic variables. Correlative studies will be done to examine the relationship between the patient's perceived pain scores and several exploratory variables. Results of this study may change the current type of anesthetic used pre-BMBs thus improving patient comfort.
NCT00465439 ↗	Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal	Completed	Hamilton Health Sciences Corporation	N/A	2007-05-01	This randomized controlled trial will examine the impact of local anesthetic on the frequency of vasovagal reactions and the patients perception of pain during femoral arterial sheath removal after percutaneous coronary intervention.

Clinical Trial Conditions for Xylocaine

Condition Name

Condition Name for Xylocaine
Intervention	Trials
Pain	18
Anesthesia	8
Postoperative Pain	5
Anesthesia, Local	5

Condition MeSH

Condition MeSH for Xylocaine
Intervention	Trials
Pain, Postoperative	13
Syndrome	6
Neuralgia	4
Carpal Tunnel Syndrome	3

Clinical Trial Locations for Xylocaine

Trials by Country

Trials by Country for Xylocaine
Location	Trials
United States	70
Canada	17
Egypt	17
France	13
Saudi Arabia	8

Trials by US State

Trials by US State for Xylocaine
Location	Trials
North Carolina	7
California	7
Pennsylvania	6
Minnesota	5
Ohio	5

Clinical Trial Progress for Xylocaine

Clinical Trial Phase

Clinical Trial Phase for Xylocaine
Clinical Trial Phase	Trials
Phase 4	56
Phase 3	12
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Xylocaine
Clinical Trial Phase	Trials
Completed	89
Unknown status	19
Recruiting	18

Clinical Trial Sponsors for Xylocaine

Sponsor Name

Sponsor Name for Xylocaine
Sponsor	Trials
University of North Carolina, Chapel Hill	5
Mayo Clinic	5
University of Utah	4

Sponsor Type

Sponsor Type for Xylocaine
Sponsor	Trials
Other	187
Industry	7
NIH	6

Xylocaine (Lidocaine): Clinical Trials, Market Analysis, and Projections

Introduction to Xylocaine (Lidocaine)

Xylocaine, commonly known as lidocaine, is a widely used local anesthetic and antiarrhythmic drug. It has been a staple in medical practice for decades, particularly in surgical and dental procedures. Recent research has unveiled new potential uses for lidocaine, including its application in cancer treatment.

Clinical Trials and New Applications

Lidocaine in Cancer Treatment

Recent studies have shown promising results for lidocaine as a potential tool in cancer treatment. Lidocaine activates the bitter taste receptor T2R14, which is expressed in various cancer cells, including those from head and neck cancer and breast cancer. This activation can trigger apoptosis, or cell death, in cancer cells[1].

A key study highlighted the use of lidocaine in breast cancer, where it was observed to kill breast cancer cells and prevent their migration in lab settings. This research has led to discussions about conducting clinical trials to explore lidocaine's anti-cancer effects further[1].

Upcoming Clinical Trials

Researchers are in the preliminary phases of designing a clinical trial to investigate the use of lidocaine in treating HPV-associated squamous cell carcinoma, a type of head and neck cancer. The trial aims to inject lidocaine into or around tumors to activate the cancer-killing effect of the T2R14 receptor. This approach is particularly appealing due to its potential to be less toxic than traditional chemotherapy[1].

Market Analysis

Global Local Anesthesia Drugs Market

The global local anesthesia drugs market, which includes lidocaine, is expected to grow significantly. By 2025, the market is projected to reach USD 5.26 billion and is anticipated to grow at a compound annual growth rate (CAGR) of 3.40% to reach USD 6.22 billion by 2030. North America currently holds the largest market share, while the Asia-Pacific region is expected to be the fastest-growing market during the forecast period[5].

Lidocaine Hydrochloride Market

The lidocaine hydrochloride market is also experiencing growth, driven by an increase in surgical procedures, including dental, cosmetic, and plastic surgeries. The market is expected to grow at a CAGR of 6.5% from 2024 to 2030. Technological advancements and the expanding use of lidocaine hydrochloride for postoperative pain management are key factors contributing to this growth[2].

Lidocaine Transdermal Patch Market

The lidocaine transdermal patch market is another segment that is gaining traction. This market is projected to reach $7934.75 million by 2030, growing at a CAGR of 1.9% from 2024 to 2030. The growth is facilitated by ongoing research and development aimed at improving the safety, effectiveness, and half-life of these patches. Additionally, the increasing emphasis on home healthcare and the extension of indications for these patches into new therapeutic domains are driving market expansion[3].

Key Drivers of Market Growth

Increasing Surgical Procedures

The rise in the number of surgical procedures globally, including dental, cosmetic, and plastic surgeries, is a significant driver of the lidocaine market. This increase is particularly notable in North America, where the geriatric population is growing, leading to more surgical interventions[2].

Technological Developments

Advancements in surgical procedures and the development of new technologies are enhancing the safety and effectiveness of lidocaine. These innovations are crucial for the market's growth, as they improve patient outcomes and expand the therapeutic uses of lidocaine[3].

Home Healthcare Trends

The increasing preference for managing chronic illnesses at home is driving the demand for convenient pain treatment options like lidocaine transdermal patches. This trend is expected to continue, contributing to the market's expansion[3].

Challenges and Considerations

Specificity and Targeting

One of the challenges in using lidocaine for cancer treatment is ensuring its specificity to cancer cells. Unlike traditional chemotherapy, which affects many rapidly dividing cells, lidocaine needs to be targeted precisely to the cancer cells to maximize its therapeutic effect while minimizing side effects[1].

Clinical Trial Oversight

Researchers emphasize the importance of evaluating new therapies like lidocaine in a clinical trial setting with proper oversight. This ensures that patients receive treatments that are safe and effective, and it helps in making informed decisions about their care[1].

Expert Insights

"Patients, when they're diagnosed with cancer, they're looking for solutions. Sometimes a patient might feel like they're in a vulnerable position where they are just trying to grab anything that might help them. These types of things should be evaluated in a clinical trial setting with the right oversight." - Carey, as quoted in an article on the potential use of lidocaine in cancer treatment[1].

Key Takeaways

• Clinical Trials: Lidocaine is being explored for its potential anti-cancer effects, particularly in head and neck cancer and breast cancer, with upcoming clinical trials planned.
• Market Growth: The global local anesthesia drugs market, including lidocaine, is expected to grow significantly, driven by increasing surgical procedures and technological advancements.
• Market Segments: The lidocaine hydrochloride and transdermal patch markets are also experiencing growth due to their expanding therapeutic uses and the increasing emphasis on home healthcare.
• Challenges: Ensuring the specificity of lidocaine to cancer cells and conducting clinical trials with proper oversight are crucial for its successful application in cancer treatment.

FAQs

What is the current status of using lidocaine in cancer treatment?

Lidocaine is being researched for its potential anti-cancer effects, particularly through its activation of the T2R14 receptor in cancer cells. Clinical trials are in the preliminary phases to explore its use in treating HPV-associated squamous cell carcinoma and other types of cancer.

How is the lidocaine market expected to grow?

The lidocaine market is expected to grow significantly, with the global local anesthesia drugs market reaching USD 6.22 billion by 2030. The lidocaine hydrochloride market is projected to grow at a CAGR of 6.5% from 2024 to 2030, and the lidocaine transdermal patch market is expected to reach $7934.75 million by 2030.

What are the key drivers of the lidocaine market growth?

Key drivers include the increase in surgical procedures, technological advancements, and the growing emphasis on home healthcare. These factors contribute to the expanding use of lidocaine in various therapeutic domains.

What challenges are associated with using lidocaine in cancer treatment?

Ensuring the specificity of lidocaine to cancer cells and conducting clinical trials with proper oversight are significant challenges. Researchers need to target lidocaine precisely to cancer cells to maximize its therapeutic effect while minimizing side effects.

Who are the major players in the global local anesthesia drugs market?

Major players include Fresenius SE & Co. KGaA, Pacira Pharmaceuticals, Inc., Pfizer Inc., Septodont, and Baxter International Inc.

What is the fastest-growing region in the global local anesthesia drugs market?

The Asia-Pacific region is estimated to be the fastest-growing market during the forecast period from 2025 to 2030.