Outpatient, retrospective comparative study

Effects of liposomal bupivacaine on opioid use and healthcare resource utilization after outpatient spine surgery: a real-world assessment1

Study Objective: To evaluate the real-world impact on postoperative pain management using EXPAREL following outpatient spine surgery1

This was a retrospective comparative study that used deidentified patient records accessed via the IQVIA linkage claims databases of patients aged 18 years or older who underwent outpatient discectomy, laminectomy, or lumbar fusion between January 1, 2016, and December 31, 2019. The study included patients who had at least 6 months or more of continuous data before and after the procedure. Patients with extreme opioid use values (± 2 standard deviations beyond the mean, measured in MMEs) during the perioperative period were excluded. Of the 1,524 patients included in the analysis, 381 received EXPAREL and 1,143 received non-EXPAREL analgesia.

Limitations: The administrative claims databases lacked specific clinical details regarding the exact method of EXPAREL administration. Patients within and across the cohorts may have received varying multimodal pain management regimens beyond just the use or nonuse of EXPAREL, which could affect analgesia outcomes.

Primary outcomes of interest1

icon postoperative opiod consumption
Opioid use
icon opiod prescriptions
Opioid prescription fill rate
icon readmission
Post-discharge readmission
icon er
Emergency department visits

Results

EXPAREL use was associated with reduced opioid use in spine surgery

Patients in the EXPAREL cohort used fewer MMEs than the non-EXPAREL cohort before discharge from the hospital outpatient department (80 vs 132 MMEs, p=0.0041).

Following discharge, the EXPAREL cohort demonstrated a nonsignificant reduction in opioid use compared with the non-EXPAREL cohort both within 90 days (429 vs 480 MMEs, p=0.289) and between 90 and 180 days (349 vs 381 MMEs, p=0.507).

Limitations: It is possible that there are residual confounders, including painful comorbidities that could affect long-term opioid use. A formal assessment of minimal clinically important difference analysis in opioid use to confirm whether the differences in opioid use were meaningful and beneficial to patients was not performed.

diagram use of mmes e1785945763182

MME, morphine milligram equivalent.

Reference: 1. Berven S, et al. Spine J. 2024;24:1890-1899. doi:10.1016/j.spinee.2024.05.005

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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.