Inpatient

EXPAREL vs ropivacaine CISNB catheter in TSA inpatient surgeries1

Study Objective: To measure the noninferiority of EXPAREL compared with a CISNB catheter for TSA

Investigator-initiated

Key outcomes of interest were

icon pain score
Pain score
icon post operative o2 saturation
Postoperative oxygen saturation
icon postoperative opiod requirements
Postoperative opioid requirements
icon cost differences
Cost differences

Results

EXPAREL achieved noninferiority in pain control compared with continuous catheter

EXPAREL demonstrated noninferiority in pain scores compared with the continuous catheter for postoperative days 0-2.*

Average pain scores decreased on postoperative days 3 and 4 for EXPAREL vs the continuous catheter (3.4 and 3.31 [P=0.0851] vs 3.63 and 3.38 [P=0.1999]) but did not reach the threshold for statistical significance.

diagram pain score

EXPAREL had lower total costs compared with the continuous catheter in TSA

EXPAREL provided similar pain control across postoperative days 0-4 at a lower cost

Cost differences were attributed to the continuous catheter’s more involved procedure and 2 follow-up days, resulting in a higher total cost of $2,120 vs $1,115 for EXPAREL (~$1,005 difference).

diagram cost breakdown

*Noninferiority was assessed using a 1-sided t-test.

  • A retrospective chart review was conducted on patients who received a TSA by the same two surgeons at a single institution in an inpatient setting between January 1, 2008, and August 1, 2018
    • Inclusion criteria required the use of either a CISNB catheter or EXPAREL for postoperative analgesia. If a patient had multiple surgeries, only the first surgery was used
  • The final cohort included 207 patients who received EXPAREL and 126 patients who received CISNB
  • Groups were balanced in terms of age, race, sex, BMI, and LOS (P>0.05)
    • In the CISNB group, there were statistically more patients with ASA scores of 4
  • The study was a retrospective chart review causing heterogeneity in the postoperative pain medication regimen, possibly affecting opioid requirements
  • There was a lack of follow-up with patients discharged prior to postoperative day 3, which may limit the ability to assess maximum expected duration of pain control for EXPAREL
  • In the CISNB group, there were statistically more patients with ASA scores of 4
  • No statistical analyses were performed for costs

ASA, American Society of Anesthesiologists; BMI, body mass index; CISNB, continuous interscalene nerve block; LOS, length of stay; TSA, total shoulder arthroplasty.

Reference: 1. Kenny B, et al. Open J Anesthesiol. 2021;11:269-278. doi:10.4263/ojanes.2021.119026

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Important Safety 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.

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
Important Safety Information
Important Safety 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.