CLINICAL TRIALS PROFILE FOR BUPIVACAINE HYDROCHLORIDE KIT

505(b)(2) Clinical Trials for Bupivacaine Hydrochloride Kit

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
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	University of California, San Diego	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
OTC	NCT02929589 ↗	Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy	Suspended	Mike O'Callaghan Federal Hospital	Phase 3	2018-07-05	This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
OTC	NCT02929589 ↗	Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy	Suspended	Mike O'Callaghan Military Hospital	Phase 3	2018-07-05	This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
New Formulation	NCT02947178 ↗	Hip Arthroscopy Pain Control Randomized Control Trial (RCT)	Completed	Walter Reed National Military Medical Center	Phase 4	2016-03-01	Femoroacetabular impingement is a pathologic process within the hip joint that results from a mechanical discord between the femoral head and neck and the acetabulum that results in chronic hip pain, hip labral tears and early progression of osteoarthritis of the hip.1, 2 Historically an open surgical hip dislocation was performed to treat patients with this condition, however with recent advances in arthroscopy, patients more commonly now undergo arthroscopic hip surgery. From a pain management standpoint, previous attempts to provide peri-operative analgesia included intraarticular or portal analgesic injections. More recently, regional anesthesia techniques are being employed to provide more reliable and longer lasting post-operative pain control.3, 4 Currently, there are several local anesthetics available for regional anesthesia. However, they only provide an average of 12-18 hours of post-operative pain control following a single injection.5 Bupivacaine is a local anesthetic that has been used for many years by multiple routes to control post-operative pain. A new formulation of the medication prolongs the release of the active ingredient after a single injection and has been shown to result in up to 72 hours of post-operative analgesia.6, 7 To the investigator's knowledge, there has not been any studies in the literature comparing a historical control local anesthetic to this new formulation of liposomal bupivacaine via a fascial iliaca regional soft tissue infiltration blockade to provide post operative pain control following hip arthroscopy.

All Clinical Trials for Bupivacaine Hydrochloride Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001088 ↗	A Phase I Safety and Immunogenicity Trial of the Facilitated HIV-1 Gag-Pol DNA Vaccine (APL-400-047, Apollon, Inc.) Given Intramuscularly by Needle and Syringe or Biojector 2000 Needle-Free Jet Injection System in HIV-1 Uninfected Adult Volunteers	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1997-07-01	To evaluate the safety, tolerability and immunogenicity in humans of the APL-400-047 vaccine when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at the intermediate dose. [AS PER AMENDMENT 07/98: To evaluate the tolerability, safety, and immunogenicity of an increased dose in an additional group of volunteers.] DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system; thus, potentially providing the advantages of a live virus vaccination but without the potential risks. It is essential that novel vaccine strategies (including DNA-based immunizations) continue to be developed and enter Phase I human testing because to date, no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun for vaccine delivery may also have potential psychological, comfort, safety and immunologic advantages over the traditional needle and syringe method of delivery.
NCT00001090 ↗	A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined With GM-CSF in Healthy, HIV-1 Uninfected Volunteers	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the safety and immunogenicity of live recombinant canarypox ALVAC-HIV vCP205 in combination with recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) at 80 microg and 250 microg. [AS PER AMENDMENT 4/30/99: To study the safety of following 4 ALVAC immunizations with a nucleic acid gag/pol HIV-1 immunogen (APL-400-047, Wyeth-Lederle). To assess the ability of this sequence of immunization to boost the LTL, T-helper cell, and antibody response.] ALVAC-HIV candidate vaccines have induced HIV-specific CTL responses in more than half of recipients in some protocols. Depending on the HIV-1 gene products expressed by the particular ALVAC-HIV candidate vaccine, volunteers have generated anti-Envelope (vCP125, vCP205, and vCP300), anti-Gag (vCP205 and vCP300), and anti-Nef (vCP300) CTL activity. Although 3 to 4 immunizations with the different ALVAC-HIV experimental vaccines induce anti-HIV-1 neutralizing antibodies in a portion, often the majority, of volunteers, the geometric mean titers of these antibodies are modest, usually less than 50. This study will determine whether there is an increase in the anti-HIV antibody titers when GM-CSF is used as an adjuvant with ALVAC-HIV vCP205 and will also examine the kinetics and magnitude of the HIV-specific CTL response.
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.
NCT00008476 ↗	Capsaicin to Control Pain Following Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2001-01-01	This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants will undergo the following procedures in three visits: Visit 1: Patients will have touch (sensory) testing by the following three methods: 1) a warm sensor applied to the gums and the patient will rate when they first feel heat and when the heat feels painful; 2) the bristles of a small paint brush will be gently stroked across the gums, and the patient will say whether it feels painful; 3) a light touch will be applied to the gums with a small needle, and the patient will rate the pain intensity following the touch. After testing, patients will be numbed with a local anesthetic (bupivacaine) and then capsaicin or placebo (an inactive solution) will be injected next to the tooth. The tooth then will be extracted one day later. Visit 2: Patients will return to the clinic after 24 hours to repeat the same type of sensory testing. After testing, patients will be sedated and numbed with a local anesthetic (lidocaine) and given an intravenous injection of either saline or ketorolac (30 mg). After the extraction, pain ratings will be recorded every 20 minutes, for up to 6 hours. During this time, patients will be monitored for numbness, pain, side effects and vital signs (heart rate, blood pressure, respiration, etc.). Those who request pain medicine will receive acetaminophen and codeine. Patients will be required to stay for up to 3 more hours after this and then they will then be discharged with pain medicine. Visit 3: Patients will return to the clinic after another 48 hours to repeat the same sensory testing. Remaining wisdom teeth will be removed "off-study" at least three weeks following the first visit.
NCT00050362 ↗	Rofecoxib and Bupivacaine to Prevent Pain After Third Molar (Wisdom Tooth) Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2002-12-01	This study will evaluate the ability of the drugs rofecoxib and bupivacaine to prevent pain following third molar (wisdom tooth) extraction. Rofecoxib is approved to treat pain of arthritis and menstrual cramps. Bupivacaine is a local anesthetic similar to lidocaine, but longer acting. Healthy normal volunteers between 16 and 35 years of age who are in general good health and require extraction of their two lower wisdom teeth may be eligible for this study. Participants will have their two lower wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind one of the extraction sites. Ninety minutes before surgery, patients will take a dose of either rofecoxib, or a placebo (a pill with no active ingredient) by mouth. Just before surgery, they will receive an injection of either lidocaine or bupivacaine to numb the mouth and a sedative called midazolam (Versed® (Registered Trademark)) through an arm vein to cause drowsiness. After surgery, a small piece of tubing will be placed into one of the two extraction sites. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will remain in the clinic for up to 4 hours after surgery to monitor pain and drug side effects while the anesthetic wears off. During this time, they will complete pain questionnaires every 20 minutes. (Patients whose pain is unrelieved an hour after surgery may request and receive acetaminophen (Tylenol) and codeine.) The tubing then will be removed and they will be discharged with pain medicines (Tylenol, codeine and the study drug) and forms to record pain ratings. They will be given detailed instructions on how and when to take the medicines and how to record information in the pain diary. Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic (lidocaine).
NCT00119184 ↗	Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version	Terminated	Hadassah Medical Organization	Phase 1	2002-10-01	The purpose of this study is to examine whether spinal anesthesia affects the chances of successful external cephalic version (ECV) of a breech presenting fetus. Two study groups will be included; one will receive spinal anesthesia, the other will not. The non-spinal group will be permitted to cross over if ECV procedure is painful. The main outcome is success of ECV.

Clinical Trial Conditions for Bupivacaine Hydrochloride Kit

Condition Name

Condition Name for Bupivacaine Hydrochloride Kit
Intervention	Trials
Postoperative Pain	178
Pain, Postoperative	169
Pain	120
Analgesia	57

Condition MeSH

Condition MeSH for Bupivacaine Hydrochloride Kit
Intervention	Trials
Pain, Postoperative	459
Acute Pain	56
Osteoarthritis	56
Hypotension	53

Clinical Trial Locations for Bupivacaine Hydrochloride Kit

Trials by Country

Trials by Country for Bupivacaine Hydrochloride Kit
Location	Trials
United States	832
Egypt	313
Turkey	82
Canada	82
Denmark	29

Trials by US State

Trials by US State for Bupivacaine Hydrochloride Kit
Location	Trials
New York	93
California	67
Texas	64
Ohio	56
Pennsylvania	52

Clinical Trial Progress for Bupivacaine Hydrochloride Kit

Clinical Trial Phase

Clinical Trial Phase for Bupivacaine Hydrochloride Kit
Clinical Trial Phase	Trials
Phase 4	640
Phase 3	140
Phase 2/Phase 3	70

Clinical Trial Status

Clinical Trial Status for Bupivacaine Hydrochloride Kit
Clinical Trial Phase	Trials
Completed	837
Recruiting	272
Not yet recruiting	177

Clinical Trial Sponsors for Bupivacaine Hydrochloride Kit

Sponsor Name

Sponsor Name for Bupivacaine Hydrochloride Kit
Sponsor	Trials
Assiut University	99
Pacira Pharmaceuticals, Inc	59
Cairo University	50

Sponsor Type

Sponsor Type for Bupivacaine Hydrochloride Kit
Sponsor	Trials
Other	1912
Industry	144
U.S. Fed	32

Bupivacaine Hydrochloride Kit: Clinical Trials, Market Analysis, and Projections

Introduction

Bupivacaine hydrochloride is a widely used local anesthetic and pain management medication, administered via injection to numb specific areas of the body. This article delves into the recent clinical trials, market analysis, and future projections for bupivacaine hydrochloride kits.

Clinical Trials Overview

Recent Studies on Bupivacaine Hydrochloride

Recent clinical trials have focused on the efficacy and safety of bupivacaine hydrochloride, particularly in comparison to its liposomal formulation.

Liposomal Bupivacaine vs. Bupivacaine Hydrochloride

A multicenter, patient-blinded, randomized clinical trial involving 533 participants undergoing primary unilateral knee replacement surgery compared the efficacy of liposomal bupivacaine admixed with bupivacaine hydrochloride to bupivacaine hydrochloride alone. The study found no significant difference in postoperative recovery or pain management between the two groups. The Quality of Recovery 40 (QoR-40) score and pain visual analog scale (VAS) score area under the curve (AUC) from 6 to 72 hours were similar for both groups[3][4].

Pharmacokinetic Studies

Pharmacokinetic (PK) studies have been crucial in understanding the systemic exposure of bupivacaine hydrochloride. For instance, the clinical pharmacology review for HTX-011, a formulation combining bupivacaine and meloxicam, included PK data from various studies. These studies showed that the AUCinf (area under the curve to infinity) for HTX-011 was comparable to that of bupivacaine HCl from Phase 2 and 4 studies, with differences ranging from 10.2% to 29.3%. This data supports the safety and efficacy of bupivacaine hydrochloride at doses up to 400 mg administered over extended periods[1].

Market Analysis

Global Market Size and Growth

The global bupivacaine hydrochloride injection market is substantial and growing. As of 2023, the market was valued at $1120.21 million and is projected to reach $1870.27 million by 2030, growing at a CAGR of 7.6% during the forecast period. This growth is driven by the increasing demand for effective pain management solutions, particularly in surgical and outpatient settings[2].

Market Segments

The market is segmented into various categories, including by application, end-user, and geography. Specialty clinics and pain management centers are expected to witness the highest CAGR growth during the forecast period, highlighting the critical role of bupivacaine hydrochloride in these settings[2].

Regional Analysis

The Asia-Pacific region is projected to hold the largest market share during the forecast period, driven by an increase in surgical procedures and a growing need for pain management solutions. This region's market growth is also influenced by economic development and an expanding healthcare infrastructure[2].

Market Drivers and Opportunities

Increasing Surgical Procedures

The rise in surgical procedures, especially in the Asia-Pacific region, is a significant driver for the bupivacaine hydrochloride market. As more patients undergo surgeries, the demand for effective postoperative pain management increases, making bupivacaine hydrochloride a valuable tool[2].

Ambulatory and Outpatient Settings

Bupivacaine hydrochloride's prolonged duration of action makes it particularly useful in ambulatory and outpatient settings where extended pain relief is necessary. This convenience and efficacy contribute to its growing demand in these settings[2].

Technological Advancements

Advancements in drug delivery systems, such as the development of liposomal formulations, continue to influence the market. Although recent studies have shown that liposomal bupivacaine may not offer significant advantages over traditional bupivacaine hydrochloride, ongoing research could lead to more efficient and effective delivery methods[3][4].

Market Restraints and Challenges

Safety Concerns

Bupivacaine hydrochloride must be administered with caution, especially in high-risk patients or situations requiring close monitoring. Known allergies to the drug and potential systemic toxicity are significant safety concerns that can restrain market growth[2].

Cost-Effectiveness

The cost-effectiveness of bupivacaine hydrochloride, particularly in comparison to newer formulations like liposomal bupivacaine, is a challenge. Studies have shown that liposomal bupivacaine is not cost-effective compared to traditional bupivacaine hydrochloride, which could impact market adoption[3][4].

Future Projections

Market Growth

The bupivacaine hydrochloride market is expected to continue growing, driven by increasing surgical procedures and the need for effective pain management. The projected CAGR of 7.6% from 2023 to 2030 indicates a robust market with significant opportunities for growth[2].

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, will play a crucial role in the future growth of the bupivacaine hydrochloride market. Economic development and improvements in healthcare infrastructure will drive demand for pain management solutions in these regions[2].

Technological Innovations

Future innovations in drug delivery systems and formulations could further enhance the efficacy and safety of bupivacaine hydrochloride. Ongoing research and development are expected to address current challenges and improve patient outcomes[1][3][4].

Key Takeaways

• Clinical Trials: Recent trials have shown no significant difference in postoperative recovery or pain management between liposomal bupivacaine and traditional bupivacaine hydrochloride.
• Market Growth: The global bupivacaine hydrochloride market is projected to grow at a CAGR of 7.6% from 2023 to 2030.
• Regional Analysis: The Asia-Pacific region is expected to hold the largest market share due to increasing surgical procedures and improving healthcare infrastructure.
• Market Drivers: Increasing surgical procedures and the need for effective pain management in ambulatory and outpatient settings are key drivers.
• Challenges: Safety concerns and cost-effectiveness issues are significant challenges that need to be addressed.

FAQs

What is the primary use of bupivacaine hydrochloride?

Bupivacaine hydrochloride is primarily used as a local anesthetic to numb specific areas of the body and manage pain, especially in surgical and postoperative settings.

How does bupivacaine hydrochloride compare to liposomal bupivacaine?

Recent clinical trials have shown that liposomal bupivacaine does not offer significant advantages over traditional bupivacaine hydrochloride in terms of postoperative recovery or pain management.

What is the projected market size of bupivacaine hydrochloride by 2030?

The global bupivacaine hydrochloride injection market is expected to reach $1870.27 million by 2030.

Which region is expected to hold the largest market share for bupivacaine hydrochloride?

The Asia-Pacific region is projected to hold the largest market share during the forecast period due to an increase in surgical procedures and improving healthcare infrastructure.

What are the main challenges facing the bupivacaine hydrochloride market?

Safety concerns, particularly in high-risk patients, and cost-effectiveness issues are significant challenges facing the bupivacaine hydrochloride market.

Sources

1. FDA Clinical Pharmacology Review: "211988Orig1s000 CLINICAL PHARMACOLOGY REVIEW(S)".
2. Stratistics MRC: "Bupivacaine Hydrochloride Injection Market Forecasts to 2030".
3. PubMed: "A Randomized Clinical Trial - PubMed".
4. JAMA Surgery: "Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride ...".
5. Cognitive Market Research: "Bupivacaine Hcl Market Report 2024 (Global Edition)".