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Clinical efficacy
Manage pain and minimize opioids after TKA
EXPAREL vs bupivacaine HCI in TKA1
78% fewer opioids* overall opioid consumption (P=0.0048)
Significantly better PAIN CONTROL cumulative pain scores (P=0.0381)†
Results from a phase 4, double-blind, randomized, controlled trial that compared the efficacy and safety of EXPAREL 266 mg (20 mL) (n=70) and bupivacaine HCl (n=69) in a TKA study. Primary end points: area under the curve (AUC) of visual analog scale pain intensity scores 12 to 48 hours postsurgery; total opioid consumption 0 to 48 hours postsurgery. Rescue opioids for pain were available upon patient request. Rates and types of adverse events were similar between treatment groups. The most common adverse events were nausea, dizziness, and muscle spasms.
AUC, area under the curve; TKA, total knee arthroplasty; VAS, Visual Analogue Scale.
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
†Pain measured using visual analog scale.
Dosing for local infiltration & regional analgesia
Dosing for Local Infiltration
Dosing for local infiltration
For adults, a maximum dose of 266 mg (20 mL) is recommended, based on:
- Size of the surgical site
- Volume required to cover the area
- Individual patient factors that may impact the safety of an amide local anesthetic
For pediatric patients aged 6 to less than 17 years, dosing is weight based: 4 mg/kg (up to a maximum of 266 mg)
Admixing bupivacaine HCl with 266 mg (20 mL) of EXPAREL
- 20 mL vial contains 266 mg of EXPAREL, which is equivalent to 300 mg of bupivacaine HCl
- 1:2 ratio allows 150 mg of bupivacaine HCl to 266 mg of EXPAREL
Dosing for regional analgesia
For interscalene brachial plexus nerve block in adults, the recommended dose is 133 mg (10 mL), based on a study of patients undergoing rotator cuff repair or total shoulder arthroplasty
For adductor canal block in adults, the recommended dose is 133 mg (10 mL) admixed with 50 mg (10 mL) 0.5% bupivacaine HCl, for a total volume of 20 mL, based on a study of patients undergoing total knee arthroplasty
For sciatic nerve block in the popliteal fossa in adults, the recommended dose is 133 mg (10 mL), based on a study of patients undergoing bunionectomy
Admixing bupivacaine HCl with 133 mg (10 mL) of EXPAREL
- One 10 mL vial contains 133 mg of EXPAREL, which is equivalent to 150 mg of bupivacaine HCl
- 1:2 ratio allows up to 75 mg of bupivacaine HCI to 133 mg of EXPAREL
Case studies in knee surgery
See how your peers are using EXPAREL for optimal pain coverage
Multimodal protocols and results
Multimodal approaches with or without ERAS protocols have demonstrated benefits in knee
THA
Study design1
Phase 4, multicenter, randomized, double-blind, controlled, parallel-group study comparing the safety and efficacy of infiltration of EXPAREL (n=70) versus standard bupivacaine (n=69) in adults undergoing primary unilateral TKA.
Multimodal protocol
PREOPERATIVE
INTRAOPERATIVE
POSTSURGICAL
PREOPERATIVE
- Celecoxib 200 mg orally
- Acetaminophen 1000 mg orally
- Pregabalin 50 mg orally
INTRAOPERATIVE
- Both groups:
- Fentanyl (or fentanyl analogs)
- Spinal anesthesia
-
EXPAREL group:
- EXPAREL 266 mg/20 mL + 0.5% bupivacaine HCl 20 mL + saline 80 mL
-
Bupivacaine HCl group:
- 0.5% bupivacaine HCl 20 mL + saline 100 mL
POSTSURGICAL
- Celecoxib 200 mg orally every 12 hours until discharge
- Acetaminophen 975 mg to 1000 mg orally every 8 hours (maximum of 3000 mg/day)
- Immediate-release oxycodone ≤10 mg orally every 4 hours (maximum) or as needed; if oral therapy was not tolerated, morphine 2.5 to 5 mg intravenously or hydromorphone 0.5 to 1 mg intravenously every 4 hours or as needed
Patients who received multimodal analgesia with EXPAREL
Less pain
- 180.8 vs 209.3 cumulative AUC of VAS 12 to 48 hours after surgery (P=0.0381)
Fewer opioids*†
- 18.7 mg vs 84.9 mg 0 to 48 hours (P=0.0048)
More opioids free
- 10% vs 0% in the first 72 hours (P=0.01)
*Opioid intake measured in MED (mg).
†The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
MED, morphine equivalent dosing; TKA, total knee arthroplasty.
Study design2
Retrospective chart review that analyzed the outcome and feasibility of same-day discharge using an ERAS protocol in the inpatient setting in Medicare patients undergoing TKA (n=337) or THA (n=308).
Multimodal protocol
- Patients were required to have a friend or family member who could assist with nonsurgical care and provide support on the day of surgery and for 3 days after surgery, in order to maintain adherence with medication, exercise, and analgesia protocols
- Patients and their assistants were educated on realistic pain expectations, dangers related to opioid use, opioid tapering, sleep hygiene, exercise and walking programs, walker safety, wound care, and home preparation
- Individualized preoperative opioid analgesia protocol
- Non-opioid analgesia protocol consisting of acetaminophen, meloxicam, or celecoxib utilized 1 week before surgery and for 6 weeks after surgery
- Spinal anesthesia
- Periarticular infiltration with EXPAREL 266 mg/20 mL, bupivacaine HCl, and adjuncts
- THA-specific protocol
- Anterior lateral femoral cutaneous nerve field block with EXPAREL 266 mg/20 mL and bupivacaine HCl
- TKA-specific protocol
- Adductor canal block with bupivacaine HCl
- Restricted intravenous opioids during surgery
Patients who received multimodal analgesia with EXPAREL
Same-day discharge
- 84% of patients were discharged on the day of surgery
High pain management satisfaction
- 98.3% of patients were “very much” or a “good amount” satisfied with their pain management
Postsurgical opioid use*
- 84.2% of patients did not require an opioid prescription beyond the initial 7-day prescription provided at discharge
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
ERAS, enhanced recovery after surgery; THA, total hip arthroplasty; TKA, total knee arthroplasty.
ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.
Learn more about lower extremity nerve blocks with EXPAREL
Check out the news, data, and clinical resources which support the use of EXPAREL in lower extremity procedures
The latest
EXPAREL can be used to achieve sensory block in several areas
Visualize regional pain control techniques and blocks by surgical sites, explore techniques used in real-world cases, and discover how EXPAREL may supports your patients' recovery after surgery with the EXPAREL InSite tool
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.
References
- Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local infiltration analgesia with liposomal bupivacaine improves pain scores and reduces opioid use after total knee arthroplasty: results of a randomized controlled trial. J Arthroplasty. 2018;33(1):90-96.
- Van Horne A, Van Horne J. Patient-optimizing enhanced recovery pathways for total knee and hip arthroplasty in Medicare patients: implication for transition to ambulatory surgery centers. Arthroplast Today. 2019;5(4):497-502.
SEE MORE
EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration
