C section

Multimodal pain management with long-lasting, non-opioid EXPAREL improved recovery after C-section1,2

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 a significant opioid-sparing effect over 2 weeks1*
Total postsurgical opioid consumption
Postsurgical opioid consumption

LSM, least squares mean; MED, morphine equivalent dosing.

  • 2.2 times more patients were opioid-spared (54% vs 25%, respectively; P=0.0012)1
  • Provided significantly better pain control (P=0.002)1
  • Safety profiles were similar in both groups1
  • The evaluated safety population included women who breastfed1

*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*
Postsurgical opioid consumption

The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.

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
  • Postpartum depression
  • Persistent pain
  • Reduced success with breastfeeding
  • ACOG suggests women undergoing C-section may benefit from local anesthetics delivered by wound infiltration or TAP block3

Click here to read the ACOG Committee opinion on postpartum pain management

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
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 anesthesia4

  • Multicenter study including 13 sites and 186 patients4
  • 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 regimen4
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)4

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
    • An intrathecal injection of morphine (or hydromorphone) along with a single shot of bupivacaine HCl and fentanyl
  • 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.