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Open Posterior Lumbar Fusion
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 Wang is a paid consultant for Pacira BioSciences, Inc.
Background
CASE INFORMATION
Physician Name
Michael Y. Wang, MD, FACS
Affiliation
Director of Neurosurgery, Lois Pope LIFE Center
Department of Neurosurgery, Miami, FL
Department of Neurosurgery, Miami, FL
Surgical Case Performed
Open posterior lumbar fusion
Inpatient or Outpatient Procedure
Inpatient
PATIENT CHARACTERISTICS
Gender
Male
Age
67 years
Patient History
and Characteristics
and Characteristics
Patient had lumbar spinal stenosis, significant L2-L3 spondylosis, L4-L5 spondylolisthesis, and L5-S1 spondylosis. He presented with intractable back and leg pain for which he had failed conservative measures and elected to have surgical treatment
PROCEDURAL DETAILS
Incision Size
10 cm
Preoperative Medications Used
None
Preoperative Analgesics Used
None
Intraoperative Analgesics Used
General anesthesia: propofol, remifentanil, EXPAREL, bupivacaine HCl, and midazolam
Dose of EXPAREL and
Total Volume Used
Total Volume Used
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 Wang determined a total volume of approximately 120 mL would be needed to cover the surgical site. He expanded 20 mL of EXPAREL® (bupivacaine liposome injectable suspension) with 70 mL of normal saline and admixed this solution with 30 mL of 0.5% bupivacaine HCI. Bupivacaine HCI was admixed to provide short-term local analgesia in the postanesthesia care unit that overlapped with the long-term local analgesia provided by EXPAREL.
Use a thinner, small-gauge spinal needle, as it allows for closely spaced injections and deeper penetration with less trauma.
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 Wang used a 21-gauge spinal needle and divided the injectate into six 20-mL syringes and infiltrated as follows:
Step #1
Starting at the apex of the surgical site, Dr Wang infiltrated 3 to 5 mL of expanded EXPAREL® (bupivacaine liposome injectable suspension) every 1.0 to 1.5 cm circumferentially around the incision into the paraspinal musculature (total of 80 mL). For each injection, he inserted the needle at a 30-degree angle through the muscle and posterior layer of the thoracolumbar fascia into the deep paraspinal musculature (≈1 cm from bottom). Dr Wang injected as he withdrew the needle, ensuring expanded EXPAREL was also infiltrated into the more superficial paraspinal musculature (ie, above posterior layer of thoracolumbar fascia).
FIGURE 1. Paraspinal musculature
Watch the medial side of the fascial layer expand as the expanded EXPAREL is infiltrated. Be sure not to pierce through the bottom of the deep paraspinal musculature, as this can cause the expanded EXPAREL to leak out of the musculature and provide inconsistent analgesia.
Step #2
Starting at the apex of the surgical site, Dr Wang infiltrated 1 to 2 mL of expanded EXPAREL every 1.0 to 1.5 cm circumferentially around the incision into the subcutaneous tissue and skin (total of 40 mL). For each injection, he inserted the needle horizontally into the dermal-subcutaneous junction. Dr Wang injected as he withdrew the needle, ensuring expanded EXPAREL was also infiltrated into the more medial subcutaneous tissue closer to the incision.
FIGURE 2. Subcutaneous tissue and skin
Tissue should visibly expand following infiltration, with minimal leakage.
PROPER TECHNIQUE IS CRUCIAL FOR ANALGESIC COVERAGE
Dr Wang infiltrated EXPAREL® (bupivacaine liposome injectable suspension) into all tissue layers using a moving needle technique. With a moving needle technique, the injections were spread in a fan-like pattern and occurred as the needle was withdrawn to maximize the coverage area. This technique was systematically and meticulously repeated at each injection site, with overlapping diffusion of EXPAREL to ensure there were no gaps in analgesic coverage.
Awake Spinal Fusion SurgeryPerformed by: Dr Wang
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
