What is Orthopedic Surgery?

Orthopedic surgery includes many types of procedures on the skeletal system, including joints, bones, and ligaments.

TYPES OF ORTHOPEDIC SURGERIES

  • Foot and Ankle Fracture Repair
  • Spine Surgery (such as spinal fusion)
  • Knee, Hip, or Shoulder Replacement
  • Sports-Related Surgery (such as ACL or rotator cuff)

Despite ongoing efforts to end America’s opioid crisis, patients continue to receive large amounts of opioids to treat pain after surgery.

PillsIn fact, patients received between 100-130 opioid pills to help manage pain from common orthopedic procedures such as rotator cuff repair, hip replacement and knee replacement.1

There are effective non-opioid options that can be used to manage pain after surgery, including iovera° and EXPAREL

Patients receiving iovera° for total knee replacement surgery

  • Requested 45% fewer opioid prescriptions at 12 weeks after knee replacement surgery
  • Experienced less pain 2 weeks after replacement surgery
  • Were ready to leave the hospital sooner

In orthopedic surgeries, patients who received non-opioid pain management options like EXPAREL2*

  • Reported less pain
  • Required fewer opioids – In fact, 10% of patients who received EXPAREL for total knee replacement surgery did not take opioids
  • Were more discharge ready within 12 hours
  • *Based on clinical studies of surgeries using EXPAREL as an alternative to standard of care.
  • The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
  • Based on clinical studies of total knee replacement surgery with and without EXPAREL.

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Indication The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue.

Important Safety Information The iovera° system should not be used in people with the following conditions:

  • Blood that thickens when patient is exposed to cold (cryoglobulinemia), blood appearing in the urine when patient is exposed to the cold (paroxysmal cold hemoglobinuria), skin rash that appears when patient is exposed to the cold (cold urticaria), narrowing of the blood vessels in the hands and feet when patient is exposed to the cold (Raynaud’s disease), and open and/or infected wounds at or near the treatment site

Patients being treated with the iovera° system (a needle-based therapy) may experience certain reactions, including, but not limited to:

  • Bruising, swelling, inflammation and/or redness, local pain and/or tenderness, and altered feeling at the site of application

Proper use of the device as described in the User Guide can help reduce or prevent the following reactions:

  • In the area(s) where you were treated: damage to the skin from being exposed to cold or heat, darkening or lightening of the skin, and dimples in the skin
  • Outside the area(s) where you were treated: muscles may not work or move normally

Indication EXPAREL® (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.

Important Safety Information The iovera° system should not be used in people with the following conditions:

  • EXPAREL should not be used in obstetrical paracervical block anesthesia.
  • In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting.
  • In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation.
  • In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat.
  • EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days.
  • EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women.
  • Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body.
  • EXPAREL should not be injected into the spine, joints, or veins.
  • The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

For full prescribing information, please visit www.EXPAREL.com or call 1-855-793-9727.

 

References

  • 1 Pacira Pharmaceuticals, Inc. Exposing a Silent Gateway to Persistent Opioid Use: A Choices Matter Status Report. October 2018. [Analysis in the report was based on research conducted by the QuintilesIMS Institute.]
  • 2 Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local infiltration analgesia with liposomal bupivacaine improves pain scores and reduces opioid use after total knee arthroplasty: results of a randomized controlled trial. J Arthroplasty. 2018;33(1):90-96.