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Bunionectomy
This case study represents an individual clinician experience with and methodology for using EXPAREL.
Pacira BioSciences, Inc., recognizes that there are other methodologies for administering local anesthetics, as well as individual patient considerations, when selecting the dose for a specific procedure.
Please see Important Safety Information below and refer to the Full Prescribing Information.
Disclosure: Dr Parekh is a paid consultant for Pacira BioSciences, Inc.
Background
CASE INFORMATION
Physician Name
Selene G. Parekh, MD
Affiliation
Co-Chief, Foot and Ankle Division, Professor of Orthopaedic Surgery,
Duke University Medical School; Adjunct Faculty, Fuqua School of Business;
Partner, North Carolina Orthopaedic Clinic
Duke University Medical School; Adjunct Faculty, Fuqua School of Business;
Partner, North Carolina Orthopaedic Clinic
Surgical Case Performed
Chevron and Akin bunion surgery
Inpatient or Outpatient Procedure
Outpatient
PATIENT CHARACTERISTICS
Gender
Female
Age
46 years
Patient History and Characteristics
BMI: 24.5 kg/m2
Patient had a bunion on her right great toe and suffered from pain that hampered mobility
and ability to wear shoes.
Patient had a bunion on her right great toe and suffered from pain that hampered mobility
and ability to wear shoes.
PROCEDURAL DETAILS
Incision Size
3-cm medial incision over the first metatarsophalangeal joint of the right foot
Preoperative Analgesics Used
PO acetaminophen 650 mg
PO gabapentin 300 mg
PO oxycodone 5 mg
Right ankle block with 25 mL of 0.5% bupivacaine HCl and 10 mL of 1% lidocaine HCl
PO gabapentin 300 mg
PO oxycodone 5 mg
Right ankle block with 25 mL of 0.5% bupivacaine HCl and 10 mL of 1% lidocaine HCl
Dose of EXPAREL and Total Volume Used
BMI=body mass index; PO=by mouth.
The recommended dose of EXPAREL for infiltration in adults is based on the size of the surgical site, the volume required to cover the area, and individual patient factors that may impact the safety of an amide local anesthetic. The maximum dose of EXPAREL should not exceed 266 mg. The recommended dose of EXPAREL for patients aged 6 to <17 years old is 4 mg/kg, up to a maximum of 266 mg. The recommended dose of EXPAREL in adults for interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal is 133 mg. The recommended dose of EXPAREL in adults for adductor canal block is 133 mg (10 mL) admixed with 50 mg (10 mL) of 0.5% bupivacaine HCl, for a total volume of 20 mL.
EXPAREL can be administered unexpanded (20 mL) or expanded to increase volume up to a total of 300 mL (final concentration of 0.89 mg/mL [ie, 1:14 dilution by volume]) with normal (0.9%) saline or lactated Ringer’s solution.
Bupivacaine HCl (which is approved for use in patients aged 12 and older) may be administered immediately before EXPAREL or admixed in the same syringe, as long as the ratio of the milligram dose of bupivacaine HCl to EXPAREL does not exceed 1:2. Admixing may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. The toxic effects of these drugs are additive and their administration should be used with caution, including monitoring for neurological and cardiovascular effects related to local anesthetic systemic toxicity. Other than with bupivacaine, EXPAREL should not be admixed with other drugs prior to administration.
Dr Parekh separated the 20 mL of EXPAREL® (bupivacaine liposome injectable suspension) into two 10-mL syringes and attached 25-gauge needles. He did not use a smaller needle (ie, 27-gauge) due to concerns about shearing of liposomes and the early release of EXPAREL. EXPAREL was not expanded.
Dr Parekh infiltrated EXPAREL circumferentially around the incision site into the subcutaneous tissues, using multiple closely spaced injections to create a field block. With each infiltration, the needle was inserted into its hub and approximately 1 mL of EXPAREL was injected slowly as the needle was withdrawn to ensure analgesic coverage in both deep and superficial tissues.
Ankle FracturePerformed by: Dr. John W. Munz
ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.
Important Notice
- This site is intended to provide medical and product information to health care professionals in the United States.
- To report an adverse event, email drugsafety@pacira.com or call 1-855-793-9727.
- For medical inquiries related to EXPAREL, submit a request to Medical Information or call 1-855-793-9727.
- These are not all of the potential important safety considerations for EXPAREL; please see the full Prescribing Information.
Indication
EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks.
Important Safety Information
- EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
- Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via nerve block were nausea, pyrexia, headache, and constipation.
- Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.
- Do not admix lidocaine or other non-bupivacaine local anesthetics with EXPAREL. EXPAREL may be administered at least 20 minutes or more following local administration of lidocaine.
- EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for nerve blocks, and/or pregnant patients.
- Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.
Warnings and Precautions Specific to EXPAREL
- Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.
- EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block, or intravascular or intra-articular use.
- The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.
Warnings and Precautions for Bupivacaine-Containing Products
- Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression.
- Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death.
- Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients.
- Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.
- Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.
Please refer to full Prescribing Information.
SEE MORE
EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration
