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Clinical efficacy

Manage pain and minimize opioids after TKA

EXPAREL vs bupivacaine HCl in TKA (adductor canal pivotal trial)1

Superior PAIN CONTROL vs bupivacaine HCI cumulative pain scores (P<0.0074)

23% fewer opioids† total postsurgical opioid consumption (P<0.0071)

The adductor canal block pivotal trial investigated EXPAREL admixed with bupivacaine HCI versus bupivacaine HCl alone, administered as an adductor canal block (ACB) for total knee arthroplasty (TKA). Prior to the surgical procedure, patients received 133 mg (10 mL) of EXPAREL admixed with 50 mg (10 mL) of 0.5% bupivacaine HCl OR 50 mg (10 mL) of 0.5% bupivacaine HCl mixed with 10 mL normal saline via saphenous nerve (adductor canal) block. All patients also received 37.5 mg (15 mL) of 0.25% immediate-release bupivacaine HCl as an infiltration between the popliteal artery and capsule of the knee (IPACK) block immediately following study drug administration.

†The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.

Dosing for local infiltration & regional analgesia

Dosing for Local Infiltration

Dosing for local infiltration

For adults, a maximum dose of 266 mg (20 mL) is recommended, based on:

  • Size of the surgical site
  • Volume required to cover the area
  • Individual patient factors that may impact the safety of an amide local anesthetic

For pediatric patients aged 6 to less than 17 years, dosing is weight based: 4 mg/kg (up to a maximum of 266 mg)

Admixing bupivacaine HCl with 266 mg (20 mL) of EXPAREL

  • 20 mL vial contains 266 mg of EXPAREL, which is equivalent to 300 mg of bupivacaine HCl
  • 1:2 ratio allows 150 mg of bupivacaine HCl to 266 mg of EXPAREL
dosing 266

Dosing for regional analgesia

For interscalene brachial plexus nerve block in adults, the recommended dose is 133 mg (10 mL), based on a study of patients undergoing rotator cuff repair or total shoulder arthroplasty

For adductor canal block in adults, the recommended dose is 133 mg (10 mL) admixed with 50 mg (10 mL) 0.5% bupivacaine HCl, for a total volume of 20 mL, based on a study of patients undergoing total knee arthroplasty

For sciatic nerve block in the popliteal fossa in adults, the recommended dose is 133 mg (10 mL), based on a study of patients undergoing bunionectomy

Admixing bupivacaine HCl with 133 mg (10 mL) of EXPAREL

  • One 10 mL vial contains 133 mg of EXPAREL, which is equivalent to 150 mg of bupivacaine HCl
  • 1:2 ratio allows up to 75 mg of bupivacaine HCI to 133 mg of EXPAREL
dosing 133

Multimodal protocols and results

Multimodal approaches with or without ERAS protocols have demonstrated benefits

Abdominal-Wall Field Blocks

Abdominal-wall field blocks (ie, TAP)

Use a local anesthetic to provide effective regional analgesia for a range of procedures.2

Provide analgesia to the anterior abdominal wall and involve administration of a local anesthetic into the fascial plane between the transversus abdominis and internal oblique muscles.3

Approaches to abdominal-wall field blocks continue to evolve

TAP block

Originally described as a landmark-guided field block based on the lumbar triangle2

Ultrasound-guided TAP blocks

allow visualization of the needle and local anesthetic in the plane2

Additional approaches have been and continue to be developed, including2,4,5:

  • Subcostal TAP blocks
  • Bilateral 4-point TAP blocks
  • Rectus sheath blocks
  • QL blocks
  • ESP blocks

ESP, erector spinae; QL, quadratus lumborum; TAP, transversus abdominis plane.

A PECS (ultrasound-guided medial and lateral pectoralis nerve) block is a less invasive technique for providing analgesia after breast surgery compared with standard approaches such as thoracic epidural, paravertebral,intercostal nerve, and interpleural blocks.6,7

PECS blocks are applied in the pectoral and axillary regions, with the muscles in both regions innervated by the brachial plexus.7

In PECS I and PECS II field infiltration, ultrasound guidance can be used to identify the appropriate fascial plane(s) and to deposit local anesthetic to provide regional analgesia.6

These techniques provide effective analgesia after breast surgery and, unlike thoracic paravertebral and epidural blocks, are not associated with sympathetic blocks.6

EXPAREL can be used to achieve sensory block in several areas

Visualize regional pain control techniques and blocks by surgical sites, explore techniques used in real-world cases, and discover how EXPAREL may support your patients' recovery after surgery with the EXPAREL InSite tool

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

*EXPAREL is indicated to provide analgesia

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.

References

  1. Gadsden J, Hamilton M, Schwartz G, et al. Liposomal bupivacaine via adductor canal block after total knee arthroplasty: a randomized, double-blind, phase 3 trial. Poster presented at: 48th Annual Regional Anesthesiology and Acute Pain Medicine Meeting; April 20, 2023; Hollywood, FL. Poster 4381.
  2. Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645.
  3. Gadsden J, Ayad S, Gonzales JJ, Mehta J, Boublik J, Hutchins J. Evolution of transversus abdominis plane infiltration techniques for postsurgical analgesia following abdominal surgeries. Local Reg Anesth. 2015;8:113-117.
  4. Børglum J, Jensen K. Abdominal surgery: advances in the use of ultrasound-guided truncal blocks for perioperative pain management. In: Derbel F, ed. Abdominal Surgery. Rijeka, Croatia: InTech; 2012:69-94.
  5. Viderman D, Aubakirova M, Abdildin YG. Erector spinae plane block in abdominal surgery: a meta-analysis. Front Med (Lausanne). 2022;9:812531.
  6. Afonso AM, Newman MI, Seely N, et al. Multimodal analgesia in breast surgical procedures: technical and pharmacological considerations for liposomal bupivacaine use. Plast Reconstr Surg Glob Open. 2017;5(9):e1480.
  7. Blanco R, Barrington MJ. Pectoralis and Serratus Plane Blocks. In: Hadzic A. eds. Hadzic's Textbook of Regional Anesthesia and Acute Pain Management, 2e. McGraw-Hill Education; 2017:650-660. Accessed October 7, 2024. https://accessanesthesiology.mhmedical.com/content.aspx?bookid=2070§ionid=157602747
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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