Bupivacaine

Generic Name: Bupivacaine

Brand Names: Exparel, Kenalog, Marbeta, Marcaine, Marcaine With Epinephrine, Marvona Suik, P-Care M, P-Care MG, P-care, Posimir, Readysharp Anesthetics Plus Ketorolac, Readysharp-A, Readysharp-p40, Readysharp-p80, Sensorcaine, Sensorcaine With Epinephrine, Vivacaine, Xaracoll, Exparel liposomal

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₈N_₂O

CAS Number: 38396-39-3

Unique Ingredient Identifier: Y8335394RO

Background: Bupivacaine is a widely used local anesthetic agent.

Indication: As an implant, bupivacaine is indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair.

Bupivacaine, in liposome suspension, is indicated in patients aged 6 years and older for single-dose infiltration to produce postsurgical local analgesia. In adults, it is also indicated as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

Bupivacaine, in combination with meloxicam, is indicated for postsurgical analgesia in adult patients for up to 72 hours following foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.

Bupivacaine, alone or in combination with epinephrine, is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations are recommended for each type of block indicated to produce local or regional anesthesia or analgesia. Finally, its use is not indicated in all blocks given clinically significant risks associated with use.

Associated Conditions: Acute Gouty Arthritis, Adrenocortical Insufficiency, Alopecia Areata (AA), Ankylosing Spondylitis (AS), Berylliosis, Bullous dermatitis herpetiformis, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Dermatomyositis (DM), Discoid Lupus Erythematosus (DLE), Edema of the cerebrum, Epicondylitis, Hemolytic Anemia, Hypercalcemia caused by Cancer, Keloids Scars, Leukemias, Mycosis Fungoides (MF), Necrobiosis lipoidica diabeticorum, Ocular Inflammation, Ophthalmia, Sympathetic, Osteoarthritis (OA), Pain, Labor, Polymyositis, Postoperative pain, Psoriatic Arthritis, Psoriatic plaque, Pure Red Cell Aplasia, Regional Enteritis, Rheumatoid Arthritis, Secondary thrombocytopenia, Stevens-Johnson Syndrome, Synovitis, Systemic Lupus Erythematosus, Temporal Arteritis, Trichinosis, Tuberculous Meningitis, Ulcerative Colitis, Uveitis, Acute Bursitis, Acute Idiopathic Nephrotic Syndrome, Acute Lupus Erythematosus, Acute Multiple sclerosis, Acute Rheumatic heart disease, unspecified, Acute nonspecific tenosynovitis, Cystic tumors of aponeurosis, Cystic tumors of tendon, Disseminated Pulmonary Tuberculosis (TB), Exfoliative erythroderma, Inflammatory lesions of granuloma annulare, Inflammatory lesions of lichen planus, Inflammatory lesions of lichen simplex, Non-suppurative Thyroiditis, Permphigus, Severe Allergic Reactions

Associated Therapies: General Anesthesia, Local Anaesthesia therapy, Regional nerve block therapy

Clinical Trials

Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

Not Applicable

Completed

Conditions: Rotator Cuff Tear

Interventions: Drug: Normal Saline
Drug: 0.5% bupivacaine

First Posted Date: 2010-05-19

Last Posted Date: 2014-11-07

Lead Sponsor: Orlando Health, Inc.

Target Recruit Count: 96

Registration Number: NCT01126593

Locations: 🇺🇸
Orlando Orthopaedic Center, Orlando, Florida, United States

Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain

Phase 2

Completed

Conditions: Chronic Low Back Pain

Interventions: Drug: Bupivacaine TTS (Bupivacaine Patch)
Drug: Placebo patch

First Posted Date: 2010-03-31

Last Posted Date: 2022-06-15

Lead Sponsor: Durect

Target Recruit Count: 263

Registration Number: NCT01096966

Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine

Not Applicable

Completed

Conditions: Pain

Interventions: Other: Normal Saline
Drug: Bupivacaine

First Posted Date: 2010-03-16

Last Posted Date: 2018-06-25

Lead Sponsor: Vanderbilt University

Target Recruit Count: 40

Registration Number: NCT01087931

Locations: 🇺🇸
Vanderbilt Medical Center, Nashville, Tennessee, United States

Bupivacaine Versus Lidocaine on Inflammatory Regulation

Phase 4

Completed

Conditions: Pain

Interventions: Drug: Bupivacaine
Drug: Lidocaine

First Posted Date: 2010-02-02

Last Posted Date: 2018-05-31

Lead Sponsor: University of Maryland

Target Recruit Count: 11

Registration Number: NCT01060774

Locations: 🇺🇸
University of Maryland, Baltimore College of Dental Surgery, Baltimore, Maryland, United States

Bupivacaine Effectiveness and Safety in SABER® Trial

Phase 3

Completed

Conditions: Postoperative Pain
Abdominal Surgery

Interventions: Drug: SABER-Bupivacaine
Drug: SABER-Placebo
Drug: Bupivacaine HCl

First Posted Date: 2010-01-20

Last Posted Date: 2021-06-01

Lead Sponsor: Durect

Target Recruit Count: 331

Registration Number: NCT01052012

Locations: 🇳🇿
DURECT Study Site, Christchurch, New Zealand

Management of Postoperative Pain After Total Hip Arthroplasty

Phase 2

Conditions: Osteoarthritis of Hip

Interventions: Drug: Placebo
Drug: Bupivacaine

First Posted Date: 2009-12-29

Last Posted Date: 2009-12-29

Lead Sponsor: Chang Gung Memorial Hospital

Registration Number: NCT01040273

Locations: 🇨🇳
Chang Gung Memorial Hospital, Kweishian, Taoyuan, Taiwan

Transversus Abdominis Plane (TAP) Block for Cesarean Section

Not Applicable

Completed

Conditions: Hyperalgesia, Secondary

Interventions: Drug: Clonidine Placebo
Drug: Bupivacaine Placebo
Drug: Bupivacaine
Drug: Clonidine

First Posted Date: 2009-11-18

Last Posted Date: 2017-10-23

Lead Sponsor: University of Washington

Target Recruit Count: 90

Registration Number: NCT01015807

Locations: 🇺🇸
University of Washington, Seattle, Washington, United States
🇧🇷
Hospital e Maternidade Santa Joana, São Paulo, Brazil

Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Phase 4

Terminated

Conditions: Labor Pain

Interventions: Drug: Tetracaine
Drug: Bupivacaine

First Posted Date: 2009-11-01

Last Posted Date: 2017-11-08

Lead Sponsor: Wake Forest University

Target Recruit Count: 46

Registration Number: NCT01005459

Locations: 🇺🇸
Forsyth Medical Center- OB Anesthesia dept, Winston-Salem, North Carolina, United States

An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy

Phase 2

Completed

Conditions: Postoperative Pain

Interventions: Drug: SABER-Bupivacaine Treatment 2a
Drug: Placebo SABER-Bupivacaine Treatment 2b
Drug: SABER-Bupivacaine Treatment 1a
Drug: Placebo SABER-Bupivacaine Treatment 1b
Drug: Bupivacaine HCl Treatment 2c
Drug: Bupivacaine HCl Treatment 1c