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ISBP Block in Arthroscopic Rotator Cuff Repair

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 Gadsden is a paid consultant for Pacira BioSciences, Inc.

Background
CASE INFORMATION
 
Physician Name
Jeffrey C. Gadsden, MD
Affiliation
Duke University Medical Center, Associate Professor of Anesthesiology
Chief, Division of Orthopedic, Plastic, and Regional Anesthesiology
Surgical Case Performed
Interscalene brachial plexus nerve block
Inpatient or Outpatient Procedure
Outpatient
PATIENT CHARACTERISTICS
 
Gender
Female
Age
67 years
Patient History
and Characteristics
History of controlled hypertension, but active and otherwise healthy. Has been experiencing increasing shoulder pain with limited range of motion for 2 years. Scheduled to have arthroscopic rotator cuff repair and subacromial decompression under combined ultrasound-guided interscalene brachial plexus nerve block and general anesthesia, with laryngeal mask airway.
PROCEDURAL DETAILS
 
Preoperative Analgesics Used
PO acetaminophen 975 mg
PO celecoxib 400 mg
PO pregabalin 75 mg
Nerve Block Performed
Nerve Block Performed Interscalene brachial plexus nerve block with 10 mL (133 mg) of EXPAREL admixed with 5 mL of 0.5% bupivacaine HCl
Dose of EXPAREL and
Total Volume Used
15ml
PO=by mouth.

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 old 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 undiluted (20 mL) or diluted 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 physiochemical 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 toxicity. Other than with bupivacaine, EXPAREL should not be admixed with other drugs prior to administration.

Dr Gadsden performed an interscalene nerve block using ultrasound guidance to ensure accuracy of infiltration. With the patient in the lateral decubitus position (operative side up), a linear high-frequency ultrasound transducer was placed on the anteromedial aspect of the neck, approximately 2 cm above the clavicle, and the interscalene brachial plexus was identified between the anterior and middle scalene muscles.

After sterile preparation of the skin, a 21-gauge, 10-cm block needle was inserted in-plane from the lateral aspect of the transducer and directed through the middle scalene muscle. The needle was advanced until the tip was observed just lateral to the brachial plexus sheath (see Figure 1). After negative aspiration, an admixture of 10 mL of EXPAREL® (bupivacaine liposomal injectable suspension) (133 mg) and 5 mL of 0.5% bupivacaine HCI (25 mg) was administered slowly with periodic aspiration, maintaining the needle tip position throughout.

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FIGURE 1. Interscalene brachial plexus nerve block ultrasound.

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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