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Unilateral Simple Mastectomy
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 Valente is a paid consultant for Pacira BioSciences, Inc.
Background
CASE INFORMATION
Physician Name
Stephanie Valente, DO
Affiliation
Breast Surgeon, Associate Professor of Surgery
Director, Breast Surgery Fellowship Program, Cleveland Clinic, Cleveland, OH
Director, Breast Surgery Fellowship Program, Cleveland Clinic, Cleveland, OH
Surgical Case Performed
Unilateral simple mastectomy
Inpatient or Outpatient Procedure
Same-day surgery
PATIENT CHARACTERISTICS
Gender
Female
Age
51 years
Patient History and Characteristics
Patient diagnosed with breast cancer electing to undergo simple mastectomy without reconstruction
PROCEDURAL DETAILS
Incision Size
7-inch incision*
Dose of EXPAREL and
Total Volume Used
Total Volume Used
MULTIMODAL ANALGESIA AND ENHANCED RECOVERY AFTER SURGERY PROTOCOL
Preoperative Medications Used
None
Intraoperative Medications Used
40 mL of EXPAREL admixture
Postoperative Medications Used
Ice 20 minutes on/off with acetaminophen 500 mg PO q8h alternating q4h with ibuprofen 600 mg PO q8h for the first 3 days; hydrocodone/acetaminophen 5 mg/325 mg PO q4 to 6h prn for pain for a total of 10 tablets
PO=by mouth; prn=as needed; q4h=every 4 hours; q4 to 6h=every 4 to 6 hours; q8h=every 8 hours.
*Please note, incision size varies based on breast size.
*Please note, incision size varies based on breast size.
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.
ASSESSED THE SIZE OF THE SURGICAL SITE AND DEPTH OF TISSUE, THEN PREPARED INJECTION MATERIALS ACCORDINGLY
In this procedure, Dr Valente determined that a total volume of 40 mL would be needed to cover the surgical site. She admixed 20 mL of EXPAREL® (bupivacaine liposome injectable suspension) with 20 mL of 0.25% bupivacaine HCl. Bupivacaine HCl was added to provide early-onset analgesia and bridge the time to onset of the long-acting analgesia provided by EXPAREL.
Dr Valente determines the total volume of EXPAREL solution based on whether the mastectomy is unilateral or bilateral. For bilateral procedures, she usually admixes 20 mL of EXPAREL with 20 mL of 0.25% bupivacaine HCl and expands that with 20 mL of injectable normal saline for a total volume of 60 mL. This provides 30 mL of EXPAREL admixture per each breast.
DIVIDED INJECTATE INTO SYRINGES WITH NEEDLE SIZES APPROPRIATE FOR INFILTRATION (20- TO 25-GAUGE) AND PLANNED WHICH AREAS TO INFILTRATE WITH EACH INJECTION
For this procedure, Dr Valente used one 10-mL syringe with a 25-gauge, 1-inch needle, and refilled it with the remaining admixture to utilize the total volume of 40 mL when needed.
POSTMASTECTOMY
Step #1: Perform a field block around mastectomy surgical site
After performing the mastectomy, Dr Valente injected 1 to 2 mL of admixed EXPAREL® (bupivacaine liposome injectable suspension) circumferentially around the mastectomy anatomical boundaries and into the insertion of the pectoralis major muscle for a total volume of approximately 25 mL. She first palpated the ribs and injected directly on top of the rib into the muscle, then moved inferiorly along the serratus anterior muscle. She continued laterally toward the anterior border of the latissimus dorsi muscle and progressed superiorly below the clavicle.
Step #2: Infiltrate the pectoralis muscles
Next, Dr Valente injected about 5 mL of admixed EXPAREL directly into the pectoralis major muscle and then lifted up the muscle and injected about 3 to 5 mL of the EXPAREL admixture into the space between the pectoralis major and minor muscles.
Step #3: Infiltrate the drain site
Finally, Dr Valente infiltrated 3 to 5 mL of the EXPAREL admixture around the drain site. This ensured that there is adequate analgesia to an area where many patients may experience postsurgical pain. She injected around the drain site and into the subcutaneous tissues to make sure there were no gaps in analgesic coverage.
PROPER TECHNIQUE IS CRUCIAL FOR ANALGESIC COVERAGE
In order to provide adequate analgesic coverage, Dr Valente infiltrates EXPAREL® (bupivacaine liposome injectable suspension) circumferentially around the mastectomy surgical site to create a field block. She uses anatomical landmarks to guide her placement of EXPAREL. Then, Dr Valente performs a PECS block by injecting EXPAREL between the pectoralis muscles to produce regional analgesia in the anterior wall of the chest. She also ensures to infiltrate EXPAREL around the drain site, which is an area where many patients may complain of postsurgical pain.
MastectomyPerformed by: Dr Valente
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
