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Robotic-Assisted Hysterectomy
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 Bowers is a paid consultant for Pacira BioSciences, Inc.
Background
CASE INFORMATION
Physician Name
Geoffrey D. Bowers, MD, FACOG
Affiliation
Axia Women’s Health Garden State OB/GYN, Voorhees Township, NJ
Surgical Case Performed
Robotic-assisted hysterectomy
Inpatient or Outpatient Procedure
Same-day surgery
PATIENT CHARACTERISTICS
Gender
Female
Age
46 years
Patient History
and Characteristics
and Characteristics
The patient has a >2-year history of abnormal uterine bleeding due to fibroids and presented for robotic-assisted hysterectomy. Past history includes fibroids, adenomyosis, and hyperplasia
PROCEDURAL DETAILS
Incision Size
Robotic-assisted hysterectomy (four 8-mm incisions)
Dose of EXPAREL and
Total Volume Used
Total Volume Used
MULTIMODAL ANALGESIA AND ENHANCED RECOVERY AFTER SURGERY PROTOCOL
Preoperative Medications Used
Celecoxib 400 mg PO; gabapentin 400 mg PO; acetaminophen 975 mg PO; ondansetron 12 mg IV; scopolamine patch TD (day before surgery)
Intraoperative Medications Used
Preincision: 50 mL of EXPAREL solution (10 mL each for lateral incisions; 10 mL for Palmer’s point; and 10 mL on each side of the periumbilical region)
12 mg ketorolac IV; dexamethasone 0.1 mg/kg
12 mg ketorolac IV; dexamethasone 0.1 mg/kg
Postoperative Medications Used
Ibuprofen 600 mg PO q6h; hydromorphone 2 mg PO prn in PACU (1 dose)
IV=intravenous; PACU=postanesthesia care unit; PO=by mouth; prn=as needed; q6h=every 6 hours; TD=transdermal.
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 Bowers determined a total volume of 50 mL would be needed to cover the surgical site.
He admixed 20 mL of EXPAREL® (bupivacaine liposome injectable suspension) with 30 mL of bupivacaine HCl 0.5%. Bupivacaine HCl was added to provide early-onset analgesia and bridge the time to onset of the long-acting analgesia provided by EXPAREL. Dr Bowers infiltrated the surgical site with the EXPAREL admixture prior to surgery. He identified his initial incision point and infiltrated EXPAREL; then, under direct visualization, he infiltrated the remaining incisional sites with the EXPAREL admixture.
In cases that require a higher total volume, such as those involving larger incisions, Dr Bowers may add normal saline or lactated Ringer’s solution to increase the total volume to 100 mL.
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 Bowers divided the injectate into two 20-mL syringes with 21-gauge, 1.5-inch needles and refilled one syringe with the remaining 10 mL.
When infiltrating EXPAREL, Dr Bowers makes sure to infiltrate above and below the fascia and into the subcutaneous tissue using a moving needle technique to ensure coverage across all port/incisional sites. The injections were spread in a fan-like pattern and occurred as the needle was withdrawn, to maximize the coverage area.
Step #1: For lateral incisions
Dr Bowers began by infiltrating 20 mL of the EXPAREL® (bupivacaine liposome injectable suspension) solution bilaterally from transverse abdominis. He infiltrated in a fan-like pattern, delivering 3 to 4 mL of EXPAREL mixture with each injection, for a total of 10 mL on each side. Dr Bowers infiltrated above and below the fascia and into the subcutaneous tissue, parallel and along the natural lateral descending curvature of the fascial plane.
Step #2: For Palmer’s point
Dr Bowers then performed an incision at Palmer’s point. He infiltrated 10 mL of EXPAREL solution above and below the fascia and into the subcutaneous tissue. He delivered approximately 3 to 4 mL of EXPAREL solution every 1 to 2 cm deep into the tissue with each injection to ensure optimal coverage of the area.
Step #3: For periumbilical region
Finally, Dr Bowers infiltrated 20 mL of EXPAREL solution bilaterally below the fascia into the subcutaneous layer. He infiltrated 10 mL of EXPAREL on each side of the incision, injecting parallel to the surgical plane in a fan-like pattern. Dr Bowers delivered approximately 3 to 4 mL of EXPAREL mixture every 1 to 2 cm deep into the tissue with each injection to ensure optimal coverage of the area.
PROPER TECHNIQUE IS CRUCIAL FOR ANALGESIC COVERAGE
Dr Bowers infiltrated EXPAREL® (bupivacaine liposome injectable suspension) into each port site with a moving needle technique. The needle was injected down to the preperitoneal space and slowly withdrawn to the dermis level. With a moving needle technique, the injections were spread in a fan-like pattern as the needle was withdrawn to maximize the coverage area. The goal was to create a column of EXPAREL injectate from the preperitoneal space up to the dermis for maximal analgesic coverage.
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
