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Clinical efficacy
Manage pain and minimize opioids after C-section
EXPAREL TAP block vs bupivacaine TAP block in C-section study1
52% fewer opioids overall opioid consumption (P<0.0117) at 72 hours
Comparable PAIN CONTROL overall opioid consumption through 72 hours
Results from a prospective, 13-site, multicenter, randomized clinical trial showed that EXPAREL significantly improved postsurgical recovery when used in a TAP block after C-section. Primary end point: EXPAREL reduced opioid consumption by 52% compared with standard bupivacaine over 72 hours and maintained a significant opioid-minimizing effect over 2 weeks.
TAP, transversus abdominis plane.
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
Case studies in obstetrics/gynecologic surgery
See how your peers are using EXPAREL for optimal pain coverage
Clinical & economic outcomes
EXPAREL is a cost-effective option for postsurgical pain management both in the hospital and in outpatient settings
Gynecologic Oncology Robotic-Assisted Hysterectomy2
Medical center in Minnesota
Significantly less pain (P=0.05) over first 24 hours after infiltration
16.2 hours shorter LOS
63% fewer occurrences of nausea or vomiting
Cesarean Section3
Medical center in Texas
Significantly better pain control (P<0.001)
47% reduction in postsurgical opioid consumption through 3 days*
1 day shorter LOS
15% reduction in PACU discharge readiness time (25 minutes)
39% reduction in time to ambulation
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials.
Multimodal protocols and results
Multimodal approaches with or without ERAS protocols have demonstrated benefits in obstetric and gynecologic procedures
Reduced opioid use and risk of ORAEs4-8
Fewer postsurgical complications6
Higher patient satisfaction5,6
Earlier mobility4,9
Shorter hospital LOS6,7
Reduced healthcare costs7
Clinical data support the use of EXPAREL
Societies recommend opioid-minimizing pain management platforms
Leading medical societies recommend opioid-minimizing pain management strategies to enhance recovery after obstetric and gynecologic procedures
ACOG
A stepwise, multimodal pain management strategy, including local anesthetics delivered by wound infiltration or TAP block, is recommended to control pain and minimize opioid administration
Postoperative minimization of opioid use reduces nausea and vomiting, impairment of bowel function, delayed mobilization, and pulmonary morbidity9
SOAP
Multimodal analgesia, including wound infiltration or regional blocks (eg, TAP block), should be used to reduce pain, improve mobilization, reduce opioid use in the hospital after discharge, and decrease opioid side effects4
SGO
Advocate for the goal of reducing opioid misuse, and optimizing availability and use of non-opioid methods of pain control10
ERAS
Avoiding opioid use within a multimodal postoperative analgesia pathway, with greater emphasis on non-opioid medications such as liposomal bupivacaine can improve patient experience and functional recovery after surgery5
ACOG, American College of Obstetrics and Gynecologists; ERAS, enhanced recovery after surgery; LOS, length of stay; ORAE, opioid-related adverse events; SGO, Society of Gynecologic Oncology; SOAP, Society for Obstetric Anesthesia and Perinatology; TAP, transversus abdominis plane.
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
- Nedeljkovic SS, Kett A, Vallejo MC, et al. Transversus abdominis plane block with liposomal bupivacaine for pain after cesarean delivery in a multicenter, randomized, double-blind, controlled trial. Anesth Analg. 2020;131(6):1830-1839.
- Hutchins J, Vogel RI, Ghebre R, et al. Ultrasound-guided subcostal transversus abdominis plane infiltration with liposomal bupivacaine for patients undergoing robotic-assisted hysterectomy: a retrospective study. Int J Gynecol Cancer. 2015;25(5):937-941.
- Baker BW, Villadiego LG, Lake YN, et al. Transversus abdominis plane block with liposomal bupivacaine for pain control after cesarean delivery: a retrospective chart review. J Pain Res. 2018;11:3109-3116.
- Society of Obstetric Anesthesia and Perinatology (SOAP) Enhanced Recovery After Cesarean (ERAC) Consensus Statement. Society of Obstetric Anesthesia and Perinatology website. https://soap.org/SOAP-Enhanced-Recovery-After-Cesarean-Consensus-Statement.pdf Accessed Aug 25, 2020.
- Nelson G, Bakkum-Gamez Z, Kalogera E, et al. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS®) Society recommendations—2019 update. Int J Gynecol Cancer. 2019;29(4):651-668.
- Modesitt SC, Sarosiek BM, Trowbridge ER, et al. Enhanced recovery implementation in major gynecologic surgeries: effect of care standardization. Obstet Gynecol. 2016;128(3):457-466.
- Chapman JS, Roddy E, Ueda S, Brooks R, Chen LL, Chen LM. Enhanced recovery pathways for improving outcomes after minimally invasive gynecologic oncology surgery. Obstet Gynecol. 2016;128(1):138-144.
- Hedderson M, Lee D, Hunt E, et al. Enhanced recovery after surgery to change process measures and reduce opioid use after cesarean delivery: a quality improvement initiative. Obstet Gynecol. 2019;134(3):511-519.
- American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 750: Perioperative pathways: enhanced recovery after surgery. Obstet Gynecol. 2018;132(3):e120-e130.
- Lefkowits C, Duska L. Opioid use in gynecologic oncology; balancing efficacy, accessibility and safety: an SGO clinical practice statement. Gynecol Oncol. 2017;144(2):232-234.
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EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration
