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Last Updated: January 16, 2025

CLINICAL TRIALS PROFILE FOR BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE


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All Clinical Trials for Bupivacaine Hydrochloride And Epinephrine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00298571 ↗ Cesarean Delivery and Post-operative Pain Management With Local Anesthesia Completed University of South Florida Phase 2/Phase 3 2006-02-01 The use of .5% Bupivacaine with epinephrine at the time of skin closure in cesarean deliveries will decrease post-op pain.
NCT00458003 ↗ Phenylephrine in Spinal Anesthesia in Preeclamptic Patients Completed Northwestern University N/A 2006-07-01 Hypotension remains a common clinical problem after induction of spinal anesthesia for cesarean delivery. Maternal hypotension has been associated with considerable morbidity (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been the vasopressor of choice because of concerns about phenylephrine's potential adverse effect on uterine blood flow. This practice was based on animal studies which showed that ephedrine maintained cardiac output and uterine blood flow, while direct acting vasoconstrictors, e.g., phenylephrine, decreased uteroplacental perfusion. However, several recent studies have demonstrated that phenylephrine has similar efficacy to ephedrine for preventing and treating hypotension and may be associated with a lower incidence of fetal acidosis. All of these studies have been performed in healthy patients undergoing elective cesarean delivery. Preeclampsia complicates 5-6% of all pregnancies and is a significant contributor to maternal and fetal morbidity and mortality. Many preeclamptic patients require cesarean delivery of the infant. These patients often have uteroplacental insufficiency. Given the potential for significant hypotension after spinal anesthesia and its effect on an already compromised fetus, prevention of (relative) hypotension in preeclamptic patients is important. Spinal anesthesia in preeclamptic patients has been shown to have no adverse neonatal outcomes as compared to epidural anesthesia when hypotension is treated adequately. Due to problems related to management of the difficult airway and coagulopathy, both of which are more common in preeclamptic women, spinal anesthesia may be the preferred regional anesthesia technique. Recent studies have demonstrated that preeclamptic patients may experience less hypotension after spinal anesthesia than their healthy counterparts. To our knowledge, phenylephrine for the treatment of spinal anesthesia-induced hypotension has not been studied in women with preeclampsia. The aim of our study is to compare intravenous infusion regimens of phenylephrine versus ephedrine for the treatment of spinal anesthesia induced hypotension in preeclamptic patients undergoing cesarean delivery. The primary outcome variable is umbilical artery pH.
NCT00519584 ↗ Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone Terminated The Cleveland Clinic N/A 2007-07-01 This study will test the hypothesis that ropivacaine in combination with either systemic or local steroid provides comparably longer-lasting analgesia tha ropivacaine alone.
NCT00531349 ↗ Regional Anesthesia and Endometrial Cancer Recurrence Withdrawn The Cleveland Clinic Phase 3 2007-11-01 The purpose of this study is to determine whether recurrence of local and metastatic cancer after open hysterectomy for stage 1 or 2 endometrial cancer is reduced when patients receive epidural anesthesia/analgesia combined with propofol sedation rather than sevoflurane anesthesia and opioid analgesia.
NCT00636415 ↗ Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis Completed Federal University of São Paulo N/A 2004-06-01 CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of elderly people. The aim of the present study was to compare the analgesic effect of intra-articular bupivacaine and morphine in patients with knee osteoarthritis. DESIGN AND SETTING: A randomized and double-blind study was performed at a Pain Clinic of São Paulo Federal University. METHODS: Thirty-nine patients with pain for more than 3 months and an intensity higher than 3 on a numerical scale (zero to 10) were included. G1 patients received 1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and G2 patients received 25 mg (10 ml) 0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee flexion and extension angles were measured after administration of the drugs at rest and during movement. The total amount of analgesic complementation with 500 mg paracetamol was also determined.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bupivacaine Hydrochloride And Epinephrine

Condition Name

Condition Name for Bupivacaine Hydrochloride And Epinephrine
Intervention Trials
Postoperative Pain 22
Pain, Postoperative 21
Pain 16
Analgesia 9
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Condition MeSH

Condition MeSH for Bupivacaine Hydrochloride And Epinephrine
Intervention Trials
Pain, Postoperative 52
Acute Pain 11
Osteoarthritis 10
Hypotension 5
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Clinical Trial Locations for Bupivacaine Hydrochloride And Epinephrine

Trials by Country

Trials by Country for Bupivacaine Hydrochloride And Epinephrine
Location Trials
United States 88
Canada 19
Egypt 13
Brazil 6
Chile 3
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Trials by US State

Trials by US State for Bupivacaine Hydrochloride And Epinephrine
Location Trials
New York 9
Texas 8
California 7
North Carolina 7
Massachusetts 7
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Clinical Trial Progress for Bupivacaine Hydrochloride And Epinephrine

Clinical Trial Phase

Clinical Trial Phase for Bupivacaine Hydrochloride And Epinephrine
Clinical Trial Phase Trials
Phase 4 68
Phase 3 9
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Bupivacaine Hydrochloride And Epinephrine
Clinical Trial Phase Trials
Completed 72
Recruiting 28
Not yet recruiting 24
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Clinical Trial Sponsors for Bupivacaine Hydrochloride And Epinephrine

Sponsor Name

Sponsor Name for Bupivacaine Hydrochloride And Epinephrine
Sponsor Trials
Federal University of São Paulo 6
Assiut University 5
University of California, San Diego 5
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Sponsor Type

Sponsor Type for Bupivacaine Hydrochloride And Epinephrine
Sponsor Trials
Other 195
Industry 10
U.S. Fed 6
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Bupivacaine Hydrochloride and Epinephrine: Clinical Trials, Market Analysis, and Projections

Introduction

Bupivacaine hydrochloride, often combined with epinephrine, is a widely used local anesthetic and analgesic in various medical procedures. This article will delve into the current clinical trials, market analysis, and projections for this drug.

Clinical Indications and Uses

Bupivacaine hydrochloride, with or without epinephrine, is indicated for the production of local or regional anesthesia or analgesia in adults. It is used in surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures. The drug is available in different concentrations, each recommended for specific types of blocks to achieve the desired level of anesthesia or analgesia[1][2].

Mechanism of Action

Bupivacaine works primarily by inhibiting sodium channels, which prevents the initiation and transmission of nerve impulses. Additionally, it may have analgesic effects by binding to prostaglandin E2 receptors, subtype EP1, reducing fever, inflammation, and hyperalgesia[2].

Clinical Trials

Current and Ongoing Trials

One notable ongoing trial is the multicenter, randomized, double-blind, controlled trial evaluating the effect of liposomal bupivacaine (LB) versus bupivacaine hydrochloride (HCl) for preoperative ultrasound-guided erector spinae plane block (ESPB) in patients undergoing video-assisted thoracoscopic lung surgery. This trial aims to determine the analgesic efficacy and safety profile of LB compared to traditional bupivacaine HCl. The study started in September 2023 and is expected to conclude by March 2025[4].

Previous Trials

Previous studies have compared the efficacy of liposomal bupivacaine with bupivacaine plus epinephrine in various surgical settings. For instance, a smaller randomized controlled trial found that liposomal bupivacaine for intercostal nerve block did not provide significant benefits over bupivacaine plus epinephrine in mitigating postoperative pain[4].

Market Analysis

Current Market Value

The bupivacaine hydrochloride market was valued at USD 265.06 million in 2023. This market is projected to grow significantly due to the increasing demand for local anesthetics in various surgical and diagnostic procedures[5].

Market Projections

By 2030, the global bupivacaine injection market is expected to reach USD 1447 million. The 0.25% bupivacaine injection sub-segment is anticipated to be the most profitable during this forecast period, driven by its widespread use in surgical, diagnostic, therapeutic, and obstetrical procedures[3].

Market Drivers

The growth of the bupivacaine market is driven by several factors, including the increasing number of surgical procedures, the need for effective pain management, and the versatility of bupivacaine in various medical settings. The addition of epinephrine to bupivacaine solutions, which prolongs the duration of anesthesia and reduces systemic absorption, further enhances its market appeal[1][2][3].

Pharmacology and Safety

Systemic Absorption

The systemic absorption of bupivacaine is dose- and concentration-dependent, influenced by the route of administration, blood flow at the injection site, and the presence of epinephrine. Epinephrine reduces systemic absorption and prolongs the anesthetic effect[2].

Dosage and Administration

Bupivacaine hydrochloride is available in concentrations of 0.25%, 0.5%, and 0.75%. The recommended dosages vary depending on the type of block and the procedure. For example, a test dose of 3 mL of bupivacaine hydrochloride and epinephrine injection is recommended before caudal and lumbar epidural blocks to detect unintended intravascular or intrathecal injection[1].

Safety Considerations

While bupivacaine is effective, it carries risks such as systemic toxicity, high spinal block, and cardiovascular effects, especially when combined with epinephrine. Close monitoring for early clinical signs of toxicity is essential after each test dose and during the procedure[1].

Key Takeaways

  • Clinical Indications: Bupivacaine hydrochloride with or without epinephrine is used for local or regional anesthesia in various surgical and diagnostic procedures.
  • Mechanism of Action: Inhibits sodium channels and potentially binds to prostaglandin E2 receptors.
  • Ongoing Trials: Evaluating liposomal bupivacaine versus traditional bupivacaine HCl for preoperative ESPB.
  • Market Projections: Expected to reach USD 1447 million by 2030, driven by increasing demand for effective local anesthetics.
  • Pharmacology and Safety: Systemic absorption is influenced by dose, concentration, and presence of epinephrine; careful monitoring is necessary to avoid toxicity.

FAQs

What are the common concentrations of bupivacaine hydrochloride used in clinical practice?

Bupivacaine hydrochloride is commonly used in concentrations of 0.25%, 0.5%, and 0.75% for various types of blocks and procedures[1].

How does the addition of epinephrine affect bupivacaine hydrochloride?

The addition of epinephrine prolongs the duration of anesthesia, reduces systemic absorption, and helps in detecting unintended intravascular or intrathecal injection through a test dose[1][2].

What are the potential risks associated with bupivacaine hydrochloride?

Potential risks include systemic toxicity, high spinal block, and cardiovascular effects, particularly when combined with epinephrine. Close monitoring is essential to mitigate these risks[1].

What is the current market value of bupivacaine hydrochloride, and what are the projections?

The bupivacaine hydrochloride market was valued at USD 265.06 million in 2023 and is projected to reach USD 432.83 million. The global bupivacaine injection market is expected to reach USD 1447 million by 2030[3][5].

What is the purpose of the ongoing trial comparing liposomal bupivacaine and bupivacaine HCl?

The trial aims to determine the analgesic efficacy and safety profile of liposomal bupivacaine versus bupivacaine HCl for preoperative ultrasound-guided erector spinae plane block in patients undergoing video-assisted thoracoscopic lung surgery[4].

Sources

  1. Pfizer Medical Information: Bupivacaine Hydrochloride & Epinephrine Injection, USP.
  2. DrugBank: Bupivacaine: Uses, Interactions, Mechanism of Action.
  3. GlobeNewswire: Bupivacaine Injection Market to Reach USD 1447 Million by 2030.
  4. Frontiers in Medicine: Effect of liposomal bupivacaine for preoperative erector spinae plane block.
  5. DrugPatentWatch: Bupivacaine hydrochloride - Generic Drug Details.

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