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Adolescent ACL Reconstruction
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 Sethi is a paid consultant for Pacira BioSciences, Inc.
Background
CASE INFORMATION
Physician Name
Paul Sethi, MD
Affiliation
ONS
Greenwich, CT
Greenwich, CT
Surgical Case Performed
Right ACL Reconstruction With Patellar Tendon Autograft and Anterolateral Ligament Reconstruction
Inpatient or Outpatient Procedure
Outpatient ambulatory surgery center
PATIENT CHARACTERISTICS
Gender
Female
Age
16 years
Patient Weight
56 kg
Patient History
and Characteristics
and Characteristics
Patient is a high school junior, 3-sport varsity athlete, committed to play Division 1 college-level lacrosse. She had an acute, non-contact knee injury with a lateral meniscal tear and a complete tear of her ACL.
PROCEDURAL DETAILS
Incision Size
5 cm
Incision Type
Parapatellar
Preoperative Analgesics Used
600 mg of ibuprofen, 1000 mg of acetaminophen, 20 mL of 0.5% bupivacaine
Patient/Parent Education Regarding
Pain Management
Pain Management
Patient and parent education aimed at explaining the procedure, demystifying any fears and setting expectations takes place (1) in the office prior to surgery, (2) by the nurse at discharge, and (3) reinforced as part of the POD 1 follow-up phone call.
Needle Size, Number of Syringes
22-g needle
One 60-mL syringe
One 60-mL syringe
Premix or Administer EXPAREL® (bupivacaine liposome injectable suspension) Separately
EXPAREL admixed with 0.25% bupivacaine
Dosing and Administration
Although weight-based dosing guidance for pediatric patients allows for 4 mg/kg, in Dr Sethi’s clinical judgment, in consideration of incision length and procedural technique, 10 mL of EXPAREL was appropriate for this procedure.
POD, postoperative day.
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.
Prior to surgery, the patient received physical therapy and education about pain and the risks associated with opioid medications. She was educated regarding non-opioid alternatives. On the day of surgery, she was given 600 mg of ibuprofen, 1000 mg of acetaminophen, and received an ultrasound-guided adductor canal nerve block using 20 mL of 0.5% bupivacaine. In the operating room, she had meniscal repair with 3 anchors, a patellar tendon autograft affixed with 2 metal interference screws, and an anterolateral ligament reconstruction using a semitendinosus allograft affixed with two 5.5-mm suture anchors. At the end of the procedure, her wound was infiltrated with a 30-mL admixture of EXPAREL (10 mL) and 0.25% bupivacaine (20 mL). A 22-g needle was used to infiltrate the fat pad, the periosteum near the bone tunnels, the vastus medialis, the edges of the patellar tendon, and the skin edges. Small 2-mL aliquots of the mixture were delivered into the wound and a sterile waterproof dressing was applied.
POSTSURGICAL INSTRUCTIONS INCLUDING PRESCRIPTIONS PROVIDED AND RECOVERY MILESTONES AND GOALS
Cryotherapy (ice) was initiated in the recovery room. Patient reported a 1/10 NPRS pain score in the recovery room and was discharged to her home.
She used acetaminophen 1000 mg Q8 (three times a day), 10-mg tablets of ketorolac, and cryotherapy for 72 hours. She was given 10 tablets of oxycodone 5 mg on discharge to take for severe pain.
- Elevation
- Ice
- Acetaminophen 1000 mg PO 3 times a day for 72 hours
- Ibuprofen 600 mg PO 3 times a day (or ketorolac 10 mg PO 3 times a day) for 72 hours
- Physical therapy began at 48 hours
- Oxycodone 5 mg PO Q8 PRN for severe pain (10 tablets)
She initiated physical therapy at postsurgical day 2 (48 hours) and reported pain scores between 1/10 and 3/10 over the first 6 days. She was seen on postsurgical day 7, reporting a pain score of 1/10. She did not take any oxycodone pills during the entire event.
At 28 days postsurgical she eliminated the use of a brace, regained her full motion, and had no pain.
She was seen every 4 weeks and reported minimal pain. She has returned to competitive sports.
NPRS, Numerical Pain Rating Scale; PO, by mouth; PRN, as needed; Q8, once every 8 hours.
Adolescent ACL RepairPerformed by: Dr Sethi
For more information, please reference the corresponding PDF .
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
