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Full Maxillary Reconstruction

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 Quereshy is a paid consultant for Pacira BioSciences, Inc.

Background
CASE INFORMATION
 
Physician Name
Faisal A. Quereshy, MD, DDS, FACS
Affiliation
Professor/Residency Director, Oral and Maxillofacial Surgery
Case Western Reserve University School of Dental Medicine, Cleveland, OH
Surgical Case Performed
Maxillary full-arch dental rehabilitation with implants (All-on-4®)
Inpatient or Outpatient Procedure
Outpatient
PATIENT CHARACTERISTICS
 
Gender
Male
Age
39 years
Patient History
and Characteristics
BMI: 23 (kg/m2)
Patient had no relevant medical history
Social history: tobacco use (1 pack per day)
PROCEDURAL DETAILS
 
Incision Type
Crestal incision from right molar to left molar
Preoperative Medications Used
3.6 mL of 0.5% bupivacaine HCl with 1:10,000 epinephrine infiltrated into the infraorbital nerve and posterior superior alveolar nerves for local nerve blocks, and 3.6 mL of 0.5% bupivacaine HCl with 1:10,000 epinephrine infiltrated into the soft tissue of the perinasal area
Intraoperative Analgesics Used
IV fentanyl 25 mcg
IV midazolam 5 mg
Dose of EXPAREL and
Total Volume Used
20ml
BMI=body mass index; IV=intravenous.
All-on-4 is a registered trademark of Nobel Biocare.

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.

Based on the regional surface area of soft tissue dissection, Dr Quereshy determined he would need a total volume of 20 mL of expanded EXPAREL® (bupivacaine liposome injectable suspension). He expanded 10 mL (133 mg) of EXPAREL with 10 mL of lactated Ringer’s solution, and divided the injectate into two 10-mL syringes fitted with 25-gauge needles.

Prior to making the crestal incision, Dr Quereshy infiltrated the EXPAREL injectate into the soft tissue of the supraperiosteal plane using a moving needle technique. Starting on the right side, he infiltrated approximately 0.5 mL of injectate every 5 mm along the length of the planned incision, infiltrating in multiple sites in overlapping columns to distribute EXPAREL across all tissue areas.

Crestal-Incision
injection

Space infiltration sites closely together to ensure the EXPAREL injectate is distributed across all tissue areas in overlapping columns.

Full Maxillary Reconstruction (Surgical Site Infiltration)Performed by: Dr Quereshy

ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.

Important Notice

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 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.

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