Managing Back Pain Without Opioids ? Daniel Ford, PharmD, BCPS, BCCCP Pharmacy Clinical Practice Manager Pharmacy Residency Program Director NorthBay Healthcare

Itinerary Stereotypes Staying on course The Big Day Weekend Warrior Long standing arthritic “My Sciatica is Acting Up” Staying on course Avoid escalating narcotics How to dial it back The Big Day Multi… everything Know the baseline

Disclosure I have no financial conflicts to disclose I am a critical care specialist… adrenaline junkie I will be talking about off label use of medications only in relation to peer-reviewed published evidence I talk too much and hate opioids

-Weekend Warrior -Long Standing Arthritic -My Sciatica is Acting Up Case Examples -Weekend Warrior -Long Standing Arthritic -My Sciatica is Acting Up

Weekend Warrior: Acute Back Pain Non-steroidal Anti-inflammatory Drugs (NSAIDs) Better than placebo, drugs are the same, not better than exercise1 Muscle relaxants No difference in pain or function adding to NSAID3,4,5 Alone or with ibuprofen, better overall6 More sedation Acetaminophen (APAP) TID, PRN or placebo. No change in recovery time2 Corticosteroids: no benefit1 Narcotics are bad3

Acute Back Pain Winner… NSAIDS Cox-1 (GI, bleeding risks): ibuprofen, naproxen High dose “anti-inflammatory” or lower dose “analgesic” dosing doesn’t matter7 Duration: 6 hours for ibuprofen (IBU), 12 hours for naproxen GI protection: Misoprostol most effective to reduce complications, but High-dose H2RA and PPI prevent ulcers (and are better tolerated)8 Cox-2 (Cardiac risk): celecoxib

Long Standing Arthritic: Chronic Back Pain Duloxetine statistically improved pain scores and decreased depressive symptoms11 Crossover study with VAS decrease by 2 in 4 weeks, no difference in side effects12 NSAIDS: Work, but effect is limited10 Topicals (Data limited to patches for the most part) Lidocaine patch: works, OTC may even work, tolerance13 Diclofenac patch: as effective as oral14 APAP: Evidence that it doesn’t work, at all!9 Antiseizure meds: don’t work1 Opioids: work for “short term relief”… tramadol?1

Chronic Back Pain Winner… Avoid it! Exercise, strength training, physical therapy, strengthen core… anything! Duloxetine NSAIDs for short term relief Maybe a patch?

My Sciatica is Acting Up: Nerve Pain Antiseizure medications: Gabapentin and topiramate have modest effects Pregabalin was ineffective for leg pain17 Gabapentin vs pregabalin ongoing… “PAGPROS” Antidepressants: Safe ones: not enough data1 Amitriptyline: works, poor quality of evidence and frequent side effects16 Corticosteroids: no impact on pain, possible impact on function1 Benzodiazepines: ineffective (placebo better)!15

Nerve Pain Winner… No one? Tricyclic antidepressants are used… Antiseizure meds makes sense… Steroids to reduce inflammation and prevent long term damage sounds reasonable…

Unanswered Questions Around the clock medications or as needed? Can we prevent progression pharmacologically? Why don’t we have good data on this?!?! 2,847 articles minus 2,101 only abstracts/background minus 700 for “bad” study… 46 articles.

Avoiding escalation of narcotics … And tapering down when possible

Avoid escalating: CDC Guidelines18 “Be explicit and realistic about expected benefits of opioids, explaining that while opioids can reduce pain during short-term use, there is no good evidence that opioids improve pain or function with long-term use and that complete relief of pain is unlikely.” “Emphasize improvement in function as a primary goal and that function can improve even when pain is still present.” “Advise patients about serious adverse effects of opioids, including potentially fatal respiratory depression and development of a potentially serious lifelong opioid use disorder.” “Advise patients about common effects of opioids, such as constipation, dry mouth, nausea, vomiting, drowsiness, confusion, tolerance, physical dependence, and withdrawal symptoms when stopping opioids.” “Discuss effects that opioids may have on ability to safely operate a vehicle, particularly when opioids are initiated, when dosages are increased, or when other central nervous system depressants, such as benzodiazepines or alcohol, are used concurrently.”

Dial it back: CDC Guidelines18 Evaluate with 1-4 weeks of starting, then every 3 months “High-risk regimen” is > 50 morphine milligram equivalents (> 3 Percocet 10/325) Decrease by 10% total dose per week Replace with something (not drugs)

Surgery Isn’t Dan a pharmacist?

Setting realistic expectations There will be pain We will do everything we can to keep pain as minimal as safe You know your pain best, you are in the driver's seat, let us know Don’t be tough, take meds when pain is mild- moderate.

Multi… Multimodal19 Multidisciplinary Medications that can be opioid-sparing Dexmedetomidine, clonidine, ketamine, lidocaine (IV), caffeine Scheduled non-opioid pain meds (start pre-op, continue post-op) APAP, NSAIDs (ibuprofen, naproxen, celecoxib), gabapentin Multidisciplinary

A note on the myth of IV and fancy stuff Oral and boring = $3.21 APAP: $0.06 IBU: $0.10 Bupivacaine: $1.77 IV and fancy = $793.17 Ofirmev®: $38.47 Caldolor®: $14.66 Exparel®: $315 No difference in any outcome (pain, N/V, LOS in PACU, LOS) between preop IV or PO APAP!20 Exparel® vs plain bupivacaine in cervical and lumbar decompression/fusion no difference in opioid use, pain, LOS, complication rates21

Dexamethasone22 Lumbar discectomy at 1 or 2 levels 1hr pre-op 1gm APAP + 400mg ibuprofen both orally for all After induction 16mg IVP dexamethasone or placebo (NS) Post-op all patients got 1gm APAP and 400mg ibuprofen orally every 6 hours Less pain with mobilization up to 48 hr and less vomiting, no difference in pain at rest or morphine requirements, but… Pain went from Moderate to Mild! Oral morphine 24-48hr was 6mg vs 7mg

Early Recovery After Surgery (ERAS)23 Multidimensional interventions Decreased length of stay Depending on type of procedure Decreased mortality Less complications

Early Recovery After Surgery (ERAS) 24 Did not change rate of opioid prescriptions upon discharge…

Account for chronic narcotics Total daily home consumption (scheduled and “PRN-ish” meds) Convert and reduce by 20-30% and plan to provide as baseline Use 10% of that for PRN dose

References Chou R, et al. Systemic Pharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017;166:480-492. Williams CM, et al. Efficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial. Lancet. 2014;384(9954):1586-96. Friedmen BW, et al. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015;314(15): 1572-80. Friedman BW, et al. Diazepam Is No Better Than Placebo When Added to Naproxen for Acute Low Back Pain. Ann Emerg Med. 2017;70(2): 169-76 Friedman BW, et al. A Randomized, Double-Blind, Placebo-Controlled Trial of Naproxen With or Without Orphenadrine or Methocarbamol for Acute Low Back Pain. Ann Emerg Med. 2018;71(3):348-56. Childers MK, et al. Low-dose cyclobenzaprine versus combination therapy with ibuprofen for acute neck or back pain with muscle spasm: a randomized trial. Curr Med Res Opin. 2005;21(9): 1485-93 Bradley JD, et al. Comparison of an Antiinflammatory Dose of Ibuprofen, an Analgesic Dose of Ibuprofen, and Acetaminophen in the Treatment of Patients with Osteoarthritis of the Knee. NEJM. 19914;325:87-91. Rostom A, et al. Prevention of NSAID-induced gastroduodenal ulcers. Cochrane Database Syst Rev. 2002;(4):CD002296. Saragiotto BT, et al. Paracetamol for low back pain. Cochrane Database Syst Rev. 2016 Jun 7;(6):CD012230. Enthoven W, et al. Non-steroidal anti-inflammatory drugs for chronic low back pain. Cochrane Database Syst Rev. 2016 Feb 10;2:CD012087. Enomoto H, et al. Assessment of direct analgesic effect of duloxetine for chronic low back pain: post hoc path analysis of double-blind, placebo-controlled studies. J Pain Res. 2017;10:1357-68. Schukro RP, et al. Efficacy of Duloxetine in Chronic Low Back Pain with a Neuropathic Component: A Randomized, Double-blind, Placebo-controlled Crossover Trial. Anesthesiology. 2016;124(1):150-8.

References Gimbel J, et al. Lidocaine patch treatment in patients with low back pain: results of an open-label, nonrandomized pilot study. Am J Ther. 2005;12(4):311-19. Shinde VA, et al. Efficacy and Safety of Oral Diclofenac Sustained release Versus Transdermal Diclofenac Patch in Chronic Musculoskeletal Pain: A Randomized, Open Label Trial. J Pharmacol Pharmacother. 2017;8(4):166-71. Brotz D, et al. Is there a role for benzodiazepines in the management of lumbar disc prolapse with acute sciatica? Pain. 2010;149:470-5 Moore RA, et al. Amitriptyline for neuropathic pain in adults. Cochrane Database Syst Rev. 2015 Jul 6;(7):CD008242. Mathieson S. Trial of Pregabalin for Acute and Chronic Sciatica. NEJM. 2017;376(12):1111-20. Dowell D, et al. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. JAMA. 2016;315(15):1624-45. Kumar K, et al. A Review of Opioid-Sparing Modalities in Perioperative Pain Management: Methods to Decrease Opioid Use Postoperatively. Anesth Analg. 2017;125(5):1749-60 Hickman SR, et al. Randomized trial of oral versus intravenous acetaminophen for postoperative pain control.Am J Health Syst Pharm. 2018;75(6):367-75. Grieff, A. N., Ghobrial, G. M., & Jallo, J. (2016). Use of liposomal bupivacaine in the postoperative management of posterior spinal decompression. Journal of Neurosurgery: Spine, 25(1), 88-93. Nielsen RV, et al. Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial. PAIN. 2015;156:2538-44. Liu VX, et al. Enhanced Recovery After Surgery Program Implementation in 2 Surgical Populations in an Integrated Health Care Delivery System. JAMA Surgery. 2017;152(7):e171032. Brandal D, et al. Impact of Enhanced Recovery After Surgery and Opioid-Free Anesthesia on Opioid Prescriptions at Discharge From the Hospital: A Historical-Prospective Study. Anes Anlg. 2017;125(5):1784-92.

Really? What about CliffsNotes version? Chou R, et al. Systemic Pharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017;166:480-492. Dowell D, et al. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. JAMA. 2016;315(15):1624-45.

Thank you, I hope it wasn’t too painful What questions do you have?