Schoenfeld et al. have provided good news: prolonged opioid use following spine surgery was extremely rare in their large sample of opioid-naive patients from a national database. This is good news because of the abundance of harmful effects that have been established for opioids1. The resulting article emphasizes, “The outcomes documented here directly contravene the narrative that patients who undergo spine surgery, once started on prescription opioids following surgery, are at a high risk of sustained opioid use.”
Unfortunately, the mechanism by which this research contravened that narrative involved exclusion criteria that compromise the relevance of the findings for the majority of surgical patients. For example, the findings cannot be confidently generalized to any of the following groups because they were all excluded from the project: patients who are eligible for Medicare or Medicaid (approximately 34% of the U.S. population2), those with a history of cancer in the previous year (approximately 5% of the population3,4), those with a history of trauma in the previous year (approximately 10% of the population4,5), and those with a history of opioid use in the 6 months prior to surgery (after the sample had been reduced by the above exclusions, this eliminated 63% of the remaining cases).
Consequently, it appears as if this sample was representative of roughly 19% of spine surgery candidates, at best.
This reduced representativeness is noteworthy beyond the numbers because several of the exclusion criteria have unique relevance to the study’s focus on opioid use. The importance of excluding preoperative opioid users is obvious, but it is worth noting that such preoperative use has indeed been found to predict elevated postoperative use6. By excluding those who were eligible for Medicaid, the researchers eliminated a risk factor for higher rates of opioid prescriptions and greater doses per prescription7. By excluding those with a history of opioid use, those who are eligible for Medicaid, and those who had a history of trauma, the researchers excluded 3 correlates of mental illness (including substance abuse)6,8-13. Mental illness is, itself, a predictor of future opioid use14. Consequently, the exclusion criteria reduced the prominence (within the sample) of an additional risk factor for opioid use: mental illness. (Even so, these new findings still lend support to previous findings of mental illness predicting long-term opioid use.)
While this exclusion of risk factors associated with opioid use compromises the generalizability of the findings, it also allows the findings to reinforce a generalizable lesson. Specifically, the low rate of long-term opioid use that resulted from such exclusions essentially replicates the findings of prior research that persistent postoperative opioid use “is not due to surgical pain” but is instead due to “addressable patient-level predictors.”15 The new findings indicate that any patient who is still requesting opioids as of 1 month after spine surgery is clearly an outlier (at least for cases that are free from relevant, objectively verifiable complications) and is consequently in need of evaluation for “addressable patient-level predictors” (and in need of health care that addresses the predictors that are found to be relevant for that patient). The findings are also supportive of guidelines that call for surgical-discharge prescriptions of opioids to be limited to ≤2 weeks16,17.
It should also be noted that this study’s exclusion criteria appear to have produced another unusual result (in conjunction with the unusually low rate of prolonged opioid use). Specifically, the researchers identified low rates of mental health disorders in their sample. This is consistent with the low rate of long-term opioid use because mental illness is correlated with opioid use6,8-10,14. Because several of the exclusion criteria are associated with elevated rates of mental illness6,8-13, such exclusion appears to account for the low rates of mental health disorders. Further, the researchers only analyzed for an extremely limited set of mental health disorders and failed to analyze for the types of mental illness that dominate chronic pain presentations (e.g., personality disorders18,19 and the historical but scientifically validated concept of somatoform disorders20,21). Consequently, readers are warned that the low rates of mental health disorders that are reported for this sample are not generalizable to the entire population of spine surgery candidates and that previous research has revealed an elevated rate of mental illness among spine surgery candidates22.
With all of the above in mind, the lesson is that, while surgery is statistically a risk factor for long-term opioid use15,23-26, that risk is largely attributable to confounding factors such as preoperative opioid use, a history of trauma, and Medicaid eligibility (all of which are correlates of mental illness, which is, itself, a risk factor for opioid use). Findings from this study and others have highlighted additional risk factors for prolonged postoperative opioid use, which include relatively low socioeconomic status (as noted in the current study), tobacco use15, preoperative pain15, abnormal body mass index (high or low)24, middle age (highest for those aged 50 to 59 years)24, and benzodiazepine use26.
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4. United States Census Bureau. https://www.census.gov/en.html
. Accessed 2017 April 18.
5. National Trauma Institute. Trauma statistics. https://nationaltraumainstitute.org/home/trauma_statistics.html
. Accessed 2017 April 18.
6. Armaghani SJ, Lee DS, Bible JE, Archer KR, Shau DN, Kay H, Zhang C, McGirt MJ, Devin CJ. Preoperative opioid use and its association with perioperative opioid demand and postoperative opioid independence in patients undergoing spine surgery. Spine (Phila Pa 1976). 2014 Dec 1;39(25):E1524-30.
7. Sullivan MD, Edlund MJ, Fan MY, Devries A, Brennan Braden J, Martin BC. Trends in use of opioids for non-cancer pain conditions 2000-2005 in commercial and Medicaid insurance plans: the TROUP study. Pain. 2008 Aug 31;138(2):440-9. Epub 2008 Jun 10.
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9. Breckenridge J, Clark JD. Patient characteristics associated with opioid versus nonsteroidal anti-inflammatory drug management of chronic low back pain. J Pain. 2003 Aug;4(6):344-50.
10. Sullivan MD, Edlund MJ, Zhang L, Unützer J, Wells KB. Association between mental health disorders, problem drug use, and regular prescription opioid use. Arch Intern Med. 2006 Oct 23;166(19):2087-93.
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12. Michaels AJ, Michaels CE, Smith JS, Moon CH, Peterson C, Long WB. Outcome from injury: general health, work status, and satisfaction 12 months after trauma. J Trauma. 2000 May;48(5):841-8; discussion 848-50.
13. Weinberg DS, Narayanan AS, Boden KA, Breslin MA, Vallier HA. Psychiatric illness is common among patients with orthopaedic polytrauma and is linked with poor outcomes. J Bone Joint Surg Am. 2016 Mar 2;98(5):341-8.
14. Quinn P, Rickert M, Hur K, Chang Z, Krebs E, Bair M, Scott E, Gibbons R, Larsson H, Kroenke K, D’Onofrio B. (447) Psychiatric predictors of receiving prescription opioids in two national samples. J Pain. 2016 Apr;17(4S):S86. Epub 2016 Mar 24.
15. Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert AS, Kheterpal S, Nallamothu BK. New persistent opioid use after minor and major surgical procedures in US adults. JAMA Surg. 2017 Apr 12:e170504. [Epub ahead of print].
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17. Washington State Agency Medical Directors’ Group. Interagency guideline on prescribing opioids for pain. 3rd ed. Olympia, Washington: Agency Medical Directors’ Group; 2015.
18. Dersh J, Gatchel RJ, Mayer T, Polatin P, Temple OR. Prevalence of psychiatric disorders in patients with chronic disabling occupational spinal disorders. Spine (Phila Pa 1976). 2006 May 1;31(10):1156-62.
19. Gatchel RJ, Weisberg JN. Personality characteristics of patients with pain. Washington, DC: American Psychological Association; 2000.
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21. Anooshian J, Streltzer J, Goebert D. Effectiveness of a psychiatric pain clinic. Psychosomatics. 1999 May-Jun;40(3):226-32.
22. Daubs MD, Patel AA, Willick SE, Kendall RW, Hansen P, Petron DJ, Brodke DS. Clinical impression versus standardized questionnaire: the spinal surgeon’s ability to assess psychological distress. J Bone Joint Surg Am. 2010 Dec 15;92(18):2878-83. Epub 2010 Nov 12.
23. Cifuentes M, Webster B, Genevay S, Pransky G. The course of opioid prescribing for a new episode of disabling low back pain: opioid features and dose escalation. Pain. 2010 Oct;151(1):22-9. Epub 2010 Aug 11.
24. Jiang X, Orton M, Feng R, Hossain E, Malhotra NR, Zager EL, Liu R. Chronic opioid usage in surgical patients in a large academic center. Ann Surg. 2017 Apr;265(4):722-7.
25. Nguyen TH, Randolph DC, Talmage J, Succop P, Travis R. Long-term outcomes of lumbar fusion among Workers’ Compensation subjects: a historical cohort study. Spine (Phila Pa 1976). 2011 Feb 15;36(4):320-31.
26. Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and risk factors for chronic opioid use among opioid-naive patients in the postoperative period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93.