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DATA PUBLISHED
Transversus Abdominis Plane Block With Liposomal Bupivacaine for Pain After Cesarean Delivery in a Multicenter, Randomized, Double-Blind, Controlled Trial from Anesthesia & Analgesia
Long-lasting EXPAREL significantly improved BOTH clinical and economic outcomes1,2
In a prospective, 13-site, multicenter, randomized clinical trial, EXPAREL significantly improved postsurgical recovery when used in a transversus abdominis plane (TAP) block after C-section1
Primary end point: EXPAREL reduced opioid consumption by 52%, compared with standard bupivacaine, over 72 hours and maintained an opioid-minimizing effect over 2 weeks1*
Total postsurgical opioid consumption
Total opioid consumption, oral MED LSM, mg
- 2.2 times more patients were opioid-spared†(54% vs 25%, respectively; P=0.0012)1
- Safety profiles were similar in both groups1
- The evaluated safety population included women who breastfed1
LSM, least squares mean; MED, morphine equivalent dosing.
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
†Defined as patients who took no more than 1 oxycodone 10-mg tablet (or equivalent) with no reported opioid-related adverse events (ORAEs) through 72 hours.
In a retrospective study of women undergoing C-section
EXPAREL significantly reduced opioid consumption and provided significantly better pain control vs the existing standard multimodal protocol (P<0.001)2
EXPAREL Significantly Improved Discharge Time2
0.7 DAYS SOONER
2.9 days (n=97) vs 3.6 days (n=89; P=0.006)
20% improvement
EXPAREL Reduced Mean Hospital LOS2
1 DAY SOONER
2.9 days (n=97) vs 3.9 days (n=89; P<0.001)
26% reduction
EXPAREL Decreased Mean Time to Ambulation2
12 HOURS FASTER
18.7 hours (n=67) vs 30.7 hours (n=60; P<0.001)
39% reduction
EXPAREL Significantly Decreased Time to Solid Food2
9.8 HOURS FASTER
22.3 hours (n=67) vs 32.1 hours (n=60; P<0.008)
31% reduction
EXPAREL Reduced time to bowel movement2
7.5 HOURS FASTER
21.6 hours (n=67) vs 29.1 hours (n=60; P<0.05)
26% reduction
LOS, length of stay.
The most commonly reported ORAEs with EXPAREL were pruritus (44%), nausea (37%), and vomiting (16%).
EXPAREL reduced postsurgical opioid consumption (N=201)2*
Mean total postsurgical opioid consumption (MED), mg (SD)
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
See how EXPAREL is used in C-Sections
C-Section (TAP)
See how EXPAREL is administered in C-Section (TAP)
C-Section (TAP) Study
Read the C-Section (TAP) study
C-Section (Infiltration)
See how EXPAREL is administered in C-Section (Infiltration)
Randomized Controlled Trial
Read the randomized controlled trial studying EXPAREL in C-Section
American College of Obstetricians and Gynecologists (ACOG) recommends a multimodal pain management approach as key to reducing pain after childbirth3
Effective pain management is critical to optimize outcomes following childbirth2
Inadequate management of postsurgical pain can interfere with maternal-infant bonding and is associated with2
- Delayed recovery
- Persistent pain
- Postpartum depression
- Reduced success with breastfeeding
ACOG Committee opinion on postpartum pain management
ACOG suggests women undergoing C-section may benefit from local anesthetics delivered by wound infiltration or TAP block3
The retrospective study was designed to evaluate safety and efficacy of a multimodal pain management protocol with EXPAREL in a TAP block vs the existing standard multimodal protocol2
- A single-center, retrospective review of charts from 201 consecutive women aged 18 to 65 years at Texas Children’s Hospital Pavilion for Women between 2012 and 2015
- Patients underwent elective, unscheduled, or emergency C-section
- Procedures followed a multimodal pain management protocol with EXPAREL TAP block vs existing multimodal protocol alone with a multimodal pain management protocol or the same protocol with the addition of ultrasound-guided TAP block with EXPAREL
Post-cesarean delivery multimodal pain management protocol2
2012-late 2014
- Spinal-epidural anesthesia with intrathecal morphine (100 µg), plus supplemental IV analgesics:
- Dosing of IV analgesics was based on patient-reported pain intensity assessed using a numeric rating scale (NRS) (range, 0 [no pain] to 10 [worst possible pain])
- NRS scores of 1-5: patients received 3 doses of IV acetaminophen 10 mg/mL (15 mg/kg if body weight <50 kg; 1000 mg if body weight ≥50 kg) q6h, alternated with 3 doses of IV ketorolac 30 mg q6h for 24 hours
- NRS scores of 6-10: patients received IV nalbuphine 2 mg, a mixed opioid agonist-antagonist combination, every 2 hours as needed for breakthrough pain for 24 hours
- Dosing of IV analgesics was based on patient-reported pain intensity assessed using a numeric rating scale (NRS) (range, 0 [no pain] to 10 [worst possible pain])
Late 2014-2015
- Multimodal pain management protocol, plus:
- Addition of ultrasound-guided EXPAREL TAP block
- 266 mg (20 mL) EXPAREL admixed with 30 mL 0.25% bupivacaine HCl expanded with 30 mL normal saline (80 mL total admixture; 40 mL of EXPAREL admixture per side)
The prospective C-section study was a randomized, controlled, double-blind investigation using a multimodal protocol with EXPAREL in a TAP block vs standard bupivacaine in patients undergoing elective C-section and given spinal anesthesia1‡
- Multicenter study including 13 sites and 186 patients1
- Patients were randomized to receive 20 mL EXPAREL 266 mg, 20 mL 0.25% bupivacaine HCl, and 20 mL normal saline (30 mL volume on each side) for a total volume of 60 mL OR 20 mL 0.25% bupivacaine HCl and 40 mL normal saline (30 mL volume on each side; total volume of 60 mL) alone administered via TAP block after surgery1
- Efficacy was evaluated in a prespecified modified intent-to-treat (mITT) population who met study protocol criteria regarding proper administration of TAP and multimodal regimen1
Study designed to evaluate safety and efficacy of EXPAREL TAP block as part of a multimodal postsurgical analgesic regimen in adult women undergoing elective C-section (NCT03176459)1
Primary End Point
Total postsurgical opioid consumption (mg) in oral MED through 72 hours
- Multicenter, randomized, double-blind, active-controlled phase 4 study
- Adults with term pregnancies of 37-42 weeks were randomized 1:1 to receive
- 20 mL EXPAREL 266 mg, 20 mL 0.25% bupivacaine HCl, and 20 mL normal saline (30 mL volume on each side) for a total volume of 60 mL OR
- 20 mL 0.25% bupivacaine HCl and 40 mL normal saline (30 mL volume on each side) for a total volume of 60 mL
- Prior to C-section, all patients received
- Intravenous (IV) ketorolac 15 mg and IV acetaminophen 1000 mg followed by oral acetaminophen 650 mg and ibuprofen 600 mg every 6 hours (q6h) for ≤72 hours or until discharge
- At the end of surgery all patients received
- Intravenous (IV) ketorolac 15 mg and IV acetaminophen 1000 mg followed by oral acetaminophen 650 mg and ibuprofen 600 mg every 6 hours (q6h) for ≤72 hours or until discharge
Efficacy Evaluation
- Efficacy was evaluated in an mITT analysis set, which included all randomized patients who underwent C-section and met the study criteria for correct TAP placement, local anesthetic dosing, and a multimodal postsurgical analgesic regimen
- The ultrasound images for TAP placement for each patient were adjudicated blindly by an independent review committee to assess whether the TAP block was performed correctly
- Two independent reviewers were assigned for each patient
- If needed, a third reviewer was assigned to make a final determination
‡Measured using the area under the curve of imputed pain intensity scores collected from 6 to 72 hours (LSM [SE], 147.9 [21.13] vs 178.5 [19.78]), respectively.
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 [published online ahead of print July 21, 2020]. Anesth Analg.
- 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.
- American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 742: postpartum pain management. Obstet Gynecol. 2018;132(1):e35-e43.
SEE MORE
EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration
