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Effective January 1, 2025: ASP+6% reimbursement for EXPAREL when billing with code J0666 across all outpatient surgical settings.

Total Ankle Arthroplasty

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.

Background
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CASE INFORMATION
 
Physician Name
Jeff Gadsden, MD and James A. Nunley II, MD
Affiliation
Duke University Hospital, Durham, NC
Surgical Case Performed
Total ankle arthroplasty
Inpatient or Outpatient Procedure
Outpatient
PATIENT CHARACTERISTICS
 
Gender
Female
Age
54 years
Patient History and Characteristics
This patient presented with longstanding pain and deformity in her ankle after a motor vehicle accident 20 years ago, and was scheduled for total ankle replacement surgery. Her medical history was otherwise unremarkable except for mild asthma. The anesthetic plan included a sciatic nerve block in the popliteal fossa and an adductor canal block, as well as intravenous sedation. For both nerve blocks, the plan was to use an admixture of EXPAREL and bupivacaine HCl.
PROCEDURAL DETAILS
 
Incision Type
Anterior approach between the tendons of the tibialis anterior and extensor hallucis longus
Preoperative Medications Used
  • Acetaminophen 975 mg PO
  • Midazolam 2 mg IV for procedural sedation
  • Fentanyl 50 mcg IV for procedural sedation/analgesia
  • EXPAREL 266 mg (20 mL) admixed with bupivacaine HCl 0.5% 100 mg (20 mL) for use as a sciatic nerve block in the popliteal fossa and an adductor canal block
Intraoperative Medications Used
  • Propofol 75-100 mcg/kg/min IV for sedation
  • Fentanyl 25 mcg IV prn for tourniquet discomfort
Postoperative Medications Used
  • Acetaminophen 1000 mg PO QID
  • Oxycodone 5-10 mg PO q4-6h prn for breakthrough pain
IV=intravenous; PO=by mouth.
EXPAREL ADMINISTRATION DETAILS
 
Dose of EXPAREL Used
266 mg (20 mL) used in 2 identical 20-mL syringes, each containing 133 mg (10 mL) and 10 mL 0.5% bupivacaine HCl (50 mg)
Did You Expand the Volume?
No
Did You Admix With Bupivacaine?
Yes, with 20 mL of 0.5% bupivacaine (100 mg)
Total Volume Used
40ml
Needle Used
100-mm 21-gauge block needle

The recommended dose of EXPAREL for 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 (20 mL). The recommended dose of EXPAREL for patients aged 6 to <17 years is 4 mg/kg, up to a maximum of 266 mg (20 mL). The recommended dose of EXPAREL in adults for interscalene brachial plexus nerve block and sciatic nerve block in the popliteal fossa is 133 mg (10 mL). The recommended dose of EXPAREL in adults for an adductor canal block is 133 mg (10 mL) admixed with 50 mg (10 mL) 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 (maintain a minimum concentration of 0.89 mg/mL) 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 HCI, EXPAREL should not be admixed with other drugs prior to administration.

Step 1

With the patient in the lateral position and the operative side up, a linear ultrasound transducer was placed in a transverse orientation over popliteal fossa, aiming to image the popliteal artery, vein, and tibial nerve. The probe was then slid proximally until the common peroneal nerve was observed immediately lateral to the tibial nerve (ie, the bifurcation of the sciatic nerve). The goal is to perform the block at the location where the 2 nerves appear to be JUST separating but are both still within the connective tissue paraneural sheath.

step1-img

Step 2

A nerve stimulator was connected to a 21G 100-mm block needle and the current intensity set to 0.8-1.0 mA.

Step 3

After skin preparation and using sterile technique, the needle was advanced in-plane from the lateral aspect aiming to pierce the paraneural sheath between the 2 nerves. Care was taken not to contact either nerve directly. We then confirmed that an appropriate motor response (plantar flexion or dorsiflexion) was observed.

step3-img

Step 4

A test injection of 2 mL of saline confirmed that the needle tip was correctly placed within the sheath, and fluid was spreading immediately adjacent to one or both nerves. The local anesthetic mixture was then administered slowly and with intermittent aspiration, while maintaining the needle tip within the sheath. A total of 20 mL of the local anesthetic mixture was administered at this site. The needle was then withdrawn.

Step 5

The patient was repositioned supine and the ultrasound transducer placed on the anteromedial thigh, aiming to visualize the femoral artery centered beneath the sartorius muscle. The saphenous nerve was visualized immediately lateral to the artery. After skin preparation and using sterile technique, the same block needle was advanced in-plane through the sartorius muscle, aiming for the saphenous nerve. A test injection of 2 mL of saline was used to confirm correct needle tip position, followed by administration of the remaining 20 mL of local anesthetic mixture.

ADDITIONAL NOTES

  • Precision placement of the local anesthetic is critical to sciatic nerve block in the popliteal fossa success. We use small aliquots of saline to confirm that our needle tip is reliably within the paraneural sheath before commencing administration of the local anesthetic mixture. Extra-sheath administration of any local anesthetic will not be effective
  • This block technique and local anesthetic mixture is sufficient to provide surgical anesthesia within 20 to 30 minutes. We always use propofol sedation for patient comfort and to prevent movement of the patient during the procedure
  • We use a thigh tourniquet to provide hemostasis during total ankle arthroplasty.* During some longer procedures (>2-3 hr) it is common to encounter tourniquet pain and hypertension. This can be treated with small doses of IV fentanyl (eg, 25 mcg), IV ketamine (5-10 mg). Alternatively, a preoperative femoral artery block is commonly used in our institution to effectively anesthetize the afferent sympathetic fibers from the thigh, preventing tourniquet hypertension and sparing further opioid administration
*Wahal C et al. Reg Anesth Pain Med. 2021;46:228-232.
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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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