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Temporomandibular Joint Arthroplasty
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 Bouloux is a paid consultant for Pacira BioSciences, Inc.
Background
CASE INFORMATION
Physician Name
Gary F. Bouloux, MD, DDS, MDSc, FRACDS, FRACDS(OMS), FACS
Affiliation
Associate Professor of Surgery, Division of Oral and Maxillofacial Surgery, Emory University
Chief of Oral and Maxillofacial Surgery, Director of Clinical Research, Grady Memorial Hospital
Chief of Oral and Maxillofacial Surgery, Director of Clinical Research, Grady Memorial Hospital
Surgical Case Performed
Bilateral temporomandibular joint arthroplasty with left disc plication and right discectomy with fat graft
Inpatient or Outpatient Procedure
Inpatient
PATIENT CHARACTERISTICS
Gender
Female
Age
55 years
Patient History
and Characteristics
and Characteristics
Long-standing bilateral temporomandibular joint pain. Patient had tried conservative treatment for 12 months with little improvement in pain, and surgery was determined to be the best option at consultation
Pathology
Temporomandibular joint arthralgia with degenerative joint disease
PROCEDURAL DETAILS
Incision Size
40 mm
Preoperative Analgesics Used
5 mL 0.5% bupivacaine HCI with epinephrine
Intraoperative Analgesics Used
IV Toradol
12 mL 0.5% bupivacaine HCI with epinephrine to induce great auricular, auriculotemporal, and zygomaticotemporal nerve blocks
40 mL expanded EXPAREL for local infiltration
12 mL 0.5% bupivacaine HCI with epinephrine to induce great auricular, auriculotemporal, and zygomaticotemporal nerve blocks
40 mL expanded EXPAREL for local infiltration
Dose of EXPAREL and
Total Volume Used
Total Volume Used
IV=intravenous.
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 Bouloux determined that he would need approximately 6 mL of 0.5% bupivacaine HCI with epinephrine for the nerve blocks and 20 mL of expanded EXPAREL® (bupivacaine liposome injectable suspension) for local infiltration around the preauricular incision on each side. Surgical sites with more incisions or larger incisions may require that EXPAREL be expanded with larger volumes of normal saline.
DIVIDED INJECTATE INTO SYRINGES WITH NEEDLE GAUGES APPROPRIATE FOR INFILTRATION (20- TO 25-GAUGE) AND PLANNED WHICH AREAS TO INFILTRATE WITH EACH INJECTION
For this procedure, Dr Bouloux drew the 12 mL of 0.5% bupivacaine HCI with epinephrine into a 20-mL syringe for the nerve blocks. He expanded 20 mL of EXPAREL with 20 mL of normal saline for a total volume of 40 mL and divided the EXPAREL injectate evenly into two 20-mL syringes using a 25-gauge needle. He then infiltrated as follows:
Step #1
3 mL of 0.5% bupivacaine HCI with epinephrine was injected into the great auricular nerve to provide anesthesia to the inferior aspect of the incision site.
2 mL of 0.5% bupivacaine HCI with epinephrine was injected behind the neck of the condyle into the auriculotemporal nerve.
1 mL of 0.5% bupivacaine HCI with epinephrine was injected into the zygomaticotemporal nerve as it exits medial to the zygomatic arch.
FIGURE 1. Great auricular, auriculotemporal, and zygomaticotemporal blocks
Step #2
2 mL of expanded EXPAREL® (bupivacaine liposome injectable suspension) was infiltrated beneath the earlobe at a depth of 10 mm.
FIGURE 2. Beneath the earlobe
Utilize multiple overlapping injections and continue to inject as you withdraw the needle to ensure adequate analgesic coverage. Each injection should be approximately 1 mL.
Step #3
4 mL of expanded EXPAREL was infiltrated into the medial capsule and lateral pterygoid muscle.
FIGURE 3. Medial capsule and lateral pterygoid muscle
Step #4
3 mL of expanded EXPAREL was infiltrated into the belly of the temporalis muscle and into the auricle.
FIGURE 4. Temporalis muscle and auricle
Step #5
10 mL of expanded EXPAREL was infiltrated along the anterior and posterior aspects of the incision at a depth of about 7 to 8 mm per injection.
FIGURE 5. Along anterior and posterior aspects of incision site
When injecting along the incision, infiltrate parallel to the cut edge of tissue until there is visible swelling. This step may need to be repeated at a depth of 15 mm in the anterior aspect of the incision if the tissue is thick.
Step #6
1 mL of expanded EXPAREL was infiltrated posterior and medial to the mandibular condyle, 15 mm below the superior surface of the condyle.
Once completed, infiltration steps were repeated on the other side with the remaining 20 mL of expanded EXPAREL.
FIGURE 6. Behind condyle
PROPER TECHNIQUE IS CRUCIAL FOR ANALGESIC COVERAGE
Dr Bouloux 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.
Temporomandibular Joint Arthroplasty (Surgical Site Infiltration)Performed by: Dr Bouloux
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
