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    Pain Management: The First Step to a Satisfied Patient

    At the International Congress for Joint Reconstruction’s recent Modern Trends in Joint Replacement meeting, faculty member John W. Barrington, MD reminded attendees, “We live in a different world now. HCAHPS scores and patient satisfaction are the drivers for how our hospitals will be reimbursed and how we will all be measured as surgeons.”

    “If you want to have patients who are not just tolerating your care but are truly raving fans, I would suggest that you focus on 4 Ps: pain management, prevent nausea, PT protocols, and personal connection.”

    Dr. Barrington’s talk centered on the first P, pain management. He noted that randomized, controlled trials have established that improving perioperative pain management increases the odds that patients will have a rapid recovery. [1,2] In addition, a patient’s level of pain relief after surgery often reflects his or her satisfaction with the overall hospital stay.

    “The best way to stop pain is to get it before it starts, prevent the wind-up phenomenon,” Dr. Barrington said. This is best done with multimodal analgesia, he explained, to control pain as it is transduced locally, as it is translocated to the spinal cord, and finally as it is perceived in the brain.

    Adding Liposome-Bound Bupivacaine

    Dr. Barrington is affiliated with the Texas Center for Joint Replacement in Plano, Texas, a dedicated arthroplasty practice. He said that when introducing a new drug or other technology, he and his colleagues take 4 steps:

    • Examine data from investigational trials and the FDA-approved product label
    • Introduce the drug in one or more pilot studies, comparing it with the previous standard
    • Use the drug on a large scale, carefully reviewing ongoing data and sharing it in meetings and the literature
    • Participate in a large case-control study or randomized, controlled trial

    Liposome-bound bupivacaine (EXPAREL®), a long-acting anesthetic for perioperative pain control, was Dr. Barrington’s case in point.

    In November 2011 the US Food and Drug Administration approved this amide local anesthetic for single-dose infiltration into the surgical site to produce postsurgical analgesia. [3] After reviewing the existing data, Dr. Barrington began using it in September 2012.

    “The first thing that I wanted to know about this medicine was is it safe, and it absolutely is,” he said. EXPAREL has been studied in 10 randomized, controlled, double-blind trials that involved 823 patients and multiple types of surgical procedures, at doses from 66 to 532 mg. [4] It is sold in vials of 266 mg/20 mL.

    In a pilot study that involved 10 patients, Dr. Barrington compared his prior standard – neuraxial anesthesia plus Marcaine/epinephrine – with neuraxial anesthesia plus EXPAREL. He used epidural anesthesia for knees and spinal anesthesia for hips. Because the prior protocol called for 30 mL of 0.25% Marcaine/epinephrine, he injected 10 mL of saline along with the 20 mL of EXPAREL so as not to change the amount of injectate.

    Dr. Barrington found that EXPAREL use was associated with significantly decreased pain scores on POD1 and POD2. However, it was also associated with significantly increased bleeding in the drains. “Since this pilot, when I inject EXPAREL, I have chosen to inject the same amount of epinephrine as in the prior regimen,” he said.

    Pilot Study Yields Lower Postop Pain Scores

    Dr. Barrington and his partner, Roger H. Emerson, Jr., MD, both participated in the second pilot study, which investigated pain control in the PACU.

    • In one group of 18 patients, Dr. Emerson infiltrated their surgical sites with EXPAREL plus 0.5% Marcaine/epinephrine.
    • The other group of 18 patients received an infiltration of EXPAREL alone, including 10 operated on by Dr. Emerson using general anesthesia and 8 operated on by Dr. Barrington using neuraxial anesthesia (3 epidurals, 5 spinals).

    In the PACU, pain scores were 0 in all patients who received neuraxial anesthesia and EXPAREL alone. Overall, however, the mean pain score was significantly lower with EXPAREL plus 0.5% bupivacaine than with EXPAREL alone (1.3 vs. 4.2, P = .02).

    Among the patients who had general anesthesia, only 4/18 who received EXPAREL plus 0.5% Marcaine/epinephrine needed rescue opioids, versus 7/10 in the EXPAREL-alone group. However, on the floor, regardless of which type of anesthesia was used, opioid requirements in both groups were markedly decreased from typical levels.

    “Liposomal bupivacaine alone is not a PACU medicine,” Dr. Barrington said. “We want to take care of the patients by making sure we cover them in that time period right after surgery with either Marcaine/epinephrine or neuraxial anesthesia in addition to the EXPAREL. But the EXPAREL was a tremendously valuable addition because our pain scores on post-op day 1 and 2 are much, much lower.”

    Large Case-control Study plus an RCT

    EXPAREL has become the standard of care at his center, he said. He and Dr. Emerson have conducted a large case-control study comparing the first 1,000 patients treated with EXPAREL to 1,000 consecutive previous cases. They will present their findingsa the 2014 meeting of the American Academy of Orthopaedic Surgeons (AAOS) in New Orleans.

    They will also present data at the AAOS meeting showing that EXPAREL compares favorably to a continuous femoral nerve block in total knee arthroplasty (TKA).

    Dr. Barrington and Dr. Emerson have been selected to participate in a 3-center, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, efficacy, and pharmacokinetics of EXPAREL in TKA. They will soon begin enrolling 150 patients, who will be randomly assigned in groups of 50 each to 1 of 3 protocols:

    • Spinal anesthesia plus ropivacaine
    • Opioid spinal plus ropivacaine
    • Spinal anesthesia plus EXPAREL

    The primary endpoint is pain scores up to 12 hours after surgery and through POD6. Key secondary endpoints are opioid-related adverse events, various functional outcome measures, length of hospital stay, and patient satisfaction on day 14.

    Dr. Barrington’s presentation can be found on ICJR.net.

    All presentations from Modern Trends in Joint Replacement can be found here.

    References

    1. Nuelle DG, Mann K. Minimal incision protocols for anesthesia, pain management, and physical therapy with standard incisions in hip and knee arthroplasties: the effect on early outcomes. J Arthroplasty. 2007;22(1):20-25.
    2. Pour AE, Parvizi J, Sharkey PF, Hozack WJ, Rothman RH. Minimally invasive hip arthroplasty: what role does patient preconditioning play? J Bone Joint Surg Am. 2007;89(9):1920-1927.
    3. EXPAREL [package insert]. San Diego, CA: Pacira; 2012.
    4. 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.