Why Pain Control Matters

Managing pain after surgery

Pain is a subjective sensory and emotional experience associated with actual or potential tissue damage.1 Surgery, in particular, is a common source of acute pain – pain that is present after a procedure either as a result of trauma from the procedure or procedure-related complications.2

Undertreatment of postsurgical pain can result in a variety of negative effects.2 However, when a patient’s pain is adequately controlled, their body can better begin the healing process and recover from the insult of surgery.

ASA guidelines recommend the use of multimodal pain management therapy whenever possible.2

Options to control postsurgical pain

The treatment of postsurgical pain is as subjective and variable as the perception of pain. Certain surgeries are more painful than others, and patients’ perception of the amount and duration of pain is also very individual.

Opioids have been the foundation of postsurgical pain therapy. However, it is now recognized that optimal treatment of postsurgical pain often requires a combination of multiple pharmacotherapies and routes of delivery.2 This approach is called multimodal.2 In a multimodal approach, various combinations of pharmacotherapies and routes of delivery are used in an effort to prevent pain at multiple levels of the sensory pathway. Each of these options has advantages and disadvantages. The choice of which option is best for the patient and the type of surgery are important elements in the decision process.

The limitations of local anesthetics, catheters, and pumps

  • The short duration of traditional anesthetics (≤8 hours) limits their effectiveness, as most patients report moderate, severe, or extreme pain during the first few days after surgery.3,4
  • Supplementation is often needed with catheters and pumps, which can5-11
    • Limit mobility
    • Introduce risk of infection
    • Cause variable infusion rates and concentrations
    • Migrate or dislodge
  • The average cost of catheter and pump maintenance, monitoring, and materials adds up to >$60010,11

The Opioid Burden

Learn about postsurgical pain management and concerns regarding opioid use for pain.

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EXPAREL in Oral Surgery

Find information on using EXPAREL for local infiltration in oral surgery.

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Important Notice

This site is for informational purposes only and is intended to address medical questions from healthcare professionals in the United States.

To report an adverse event, e-mail drugsafety@pacira.com or dial 1-855-RX-EXPAREL (1-855-793-9727).

For medical inquiries related to EXPAREL, submit a request to Medical Information or call 1-855-RX-EXPAREL (1-855-793-9727).

These are not all of the potential important safety considerations for EXPAREL; please see the full Prescribing Information.

References

  1. Joint Commission on Accreditation of Healthcare Organizations and National Pharmaceutical Council. Pain: Current Understanding of Assessment, Management, and Treatments. December 2001. National Pharmaceutical Council website. http://www.npcnow.org/system/files/research/download/Pain-Current-Understanding-of-Assessment-Management-and-Treatments.pdf. Accessed May 26, 2016.
  2. American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(6):248-273.
  3. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54(12):1552-1559.
  4. Beauregard L, Pomp A, Choinière M. Severity and impact of pain after day-surgery. Can J Anaesth.1998;45(4):304-311.
  5. Ilfeld BM, Loland VJ, Sandhu NS, Suresh PJ, Bishop MJ, Donohue MC. Continuous femoral nerve blocks: the impact of catheter tip location relative to the femoral nerve (anterior versus posterior) on quadriceps weakness and cutaneous sensory block. Anesth Analg. 2012;115(3):721-727.
  6. Kinder R, Hsiung R. Overview of peripheral nerve blocks. In: Chu LF, Fuller A, eds. Manual of Clinical Anesthesiology. 1st ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.
  7. Process for handling elastomeric pain relief balls (ON-Q PainBuster and others) requires safety improvements. Institute for Safe Medication Practices website. https://www.ismp.org/newsletters/acutecare/articles/20090716.asp. Accessed May 26, 2016.
  8. I-Flow ON-Q pump with ONDEMAND bolus button class I recall of risk of continuous infusion at a ration greater than expected. US Food and Drug Administration website. http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm317851.htm. Accessed May 26, 2016.
  9. Continuous peripheral nerve blocks in outpatients. NYSORA–The New York School of Regional Anesthesia website. http://www.nysora.com/mobile/regional-anesthesia/foundations-of-ra/3055-continuous-peripheral-nerve-blocks-in-outpatients.html. Accessed May 26, 2016.
  10. Frost & Sullivan. New Opportunities for Hospitals to Improve Economic Efficiency and Patient Outcomes: The Case of EXPAREL™, a long-acting, non-opioid local analgesic. http://www.frost.com/prod/servlet/cpo/252218999. Accessed May 26, 2016.
  11. White PF, Kehlet H, Neal JM, Schricker T, Carr DB, Carli F; Fast-Track Surgery Study Group. The role of the anesthesiologist in fast-track surgery: from multimodal analgesia to perioperative medical care. Anesth Analg. 2007;104(6):1380-1396.

Important Safety Information

Warnings and Precautions Specific to EXPAREL

Warnings and Precautions for Bupivacaine-Containing Products

Please refer to full Prescribing Information.

Important Safety Information

Medical Information

US healthcare professionals Click Here

Non-US healthcare professionals can submit a request to medinfo@pacira.com

If you are not a healthcare professional, please discuss any questions you have regarding your health or treatment with your physician, pharmacist, nurse, or other healthcare professional.

Important information about EXPAREL®

The FDA confirms that EXPAREL has always been approved for "administration into the surgical site to produce postsurgical analgesia" for use in a variety of surgeries not limited to those studied in its pivotal trials.

"We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand—reducing postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate."

- Dave Stack, Chief Executive Officer and Chairman of Pacira

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

Important Safety Information

  • EXPAREL is contraindicated in obstetrical paracervical block anesthesia
  • In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting
  • EXPAREL is not recommended to be used in the following patient population: patients <18 years old 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. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations

Warnings and Precautions Specific to EXPAREL

  • EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks, or intravascular or intra-articular use
  • Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL

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 paresthesias. 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

Please refer to full Prescribing Information.

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