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This is a pilot study in which patients taking opioids chronically who are scheduled for spine surgery at least 4 weeks in advance will be randomly assigned to one of two groups: opioid tapering with education alone or opioid tapering with education plus cognitive behavioral therapy (CBT). The primary objective is to determine the proportion of each group that is successful in achieving their opioid tapering goals by the time of surgery.
The perioperative period represents a particularly problematic time for opioid-dependent patients. Perioperative pain is often difficult to control, with opioid tolerance, opioid-induced hyperalgesia, and withdrawal making management a challenge. In addition to these short-term challenges, opioid-dependent patients experience poorer outcomes after surgery, including both early and late complications, emergency room visits, infections, and reoperations. Spine surgery in opioid-tolerant patients increases the risk for prolonged postoperative opioid use. This risk is in addition to the risk of prolonged opioid use that surgery itself introduces. The high prevalence of opioid use in spine patients makes spine surgery an ideal surgical model in which to study opioid tapering.
This is a randomized, controlled pilot study of 45 opioid-dependent patients undergoing spine surgery. Patients will be assigned in parallel to one of the following: 1. opioid tapering with education alone or 2. opioid tapering with education plus cognitive behavioral therapy (CBT). While all patients will meet with a pain physician to design a personalized tapering program, the CBT group will receive two CBT sessions prior to surgery. Pain, depression, anxiety, and opioid withdrawal will be assessed throughout the month prior to surgery and managed appropriately. Opioid use at the time of surgery will be assessed along with pain and depression and anxiety. Hospital outcomes, including pain, opioid use, quality of recovery, and postoperative complications, will be measured. Patients will be followed upon discharge by a chronic pain physician and patients assigned to CBT will receive one additional session after surgery. All patients will also be assessed via telephone call or Zoom at 30, 90, 180, and 365 days for pain, function, and opioid use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid tapering with Cognitive Behavioral Therapy (CBT) and education | Active Comparator | The CBT group will receive two preoperative sessions and at least one postoperative session conducted via telemedicine and performed by a pain psychologist. CBT sessions will focus on training in non-pharmacologic pain-coping skills, reducing the frequency and impact of negative pain-related cognitions and emotions, and on setting realistic behavioral goals. Patients will participate in the creation of an opioid tapering plan and will receive opioid education as well as education on how to taper opioids, the possibility of increased pain, the possibility of withdrawal symptoms, and the risks related to opioids, as well as the data on worsened perioperative outcomes in patients taking opioids. |
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| Opioid tapering with education alone | Active Comparator | In this group patients will participate in the creation of an opioid tapering plan and will receive opioid education as well as education on how to taper opioids, the possibility of increased pain, the possibility of withdrawal symptoms, and the risks related to opioids, as well as the data on worsened perioperative outcomes in patients taking opioids. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid tapering with CBT and education | Other | Patients in the opioid tapering plus CBT group will set up an initial meeting with the pain physician within a few days of enrollment to set the tapering schedule. They will also have two CBT appointments set up to complete via telemedicine during the time between enrollment and surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| proportion that achieved opioid tapering goal | Achievement of the opioid tapering goal for each patient will be assessed on day of surgery and will be based on average daily OMEs taken during the three days before surgery. The opioid tapering goal will be made on the initial visit with the study pain physician and will be specific to each patient. | Perioperative prior to surgery (postoperative day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory | Brief Pain Inventory is a validated pain assessment tool that measures pain severity and its effects on daily function. | Baseline, weeks 1-4 before surgery, day of surgery (postoperative day 0), postoperative days 1-3, and postoperative days 30, 90, 180 and 365. |
| Clinical Opiate Withdrawal Scale |
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Inclusion:
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Schwenk, MD | Contact | 267-239-3319 | eric.schwenk@jefferson.edu | |
| Jeffrey Mojica, DO | Contact | jeffrey.mojica@jefferson.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Recruiting | Philadephia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34398206 | Background | Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401. | |
| 28850531 |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
| Opioid tapering with education alone | Other | Patients in this group will be instructed to continue their opioids at the same doses and frequencies they were taking up through the day of surgery. They will set up an initial meeting within a few days of enrollment with the chronic pain physician to determine the tapering schedule which will occur over 4 weeks or more leading into surgery. The patient and pain physician will collectively agree on a tapering schedule. |
|
Standardized assessment of opioid withdrawal |
| Baseline, once weekly on weeks 1-4 prior to surgery, day of surgery (postoperative day 0), postoperative day 1, and postoperative days 30, 90, 180, and 365. |
| Patient Health Questionnaire-9 | Depression screening | Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365 |
| Generalized Anxiety Disorder-2 | Standardized generalized anxiety screening | Baseline |
| Columbia Suicide Screening Assessment | This is a suicide risk screening tool | Screening period |
| Daily opioid use in hospital | This will be the average daily opioid use in the hospital | Postoperative days 0-7 |
| Hospital length of stay | Duration of hospital stay in days | Postoperative days 0-7 |
| Quality of recovery-15 | This is a validated 15-question assessment of quality of recovery | Preoperative baseline, postoperative days 1-2 |
| Hospital Anxiety and Depression Scale | Anxiety and depression assessment for the hospitalization | Postoperative days 0-3 |
| Opioid use in daily OMEs | Patient-reported daily opioid use on average in mg | Day of surgery (postoperative day 0), postoperative days 30, 90, 180 and 365 |
| Daily opioid use in OMEs from prescription drug monitoring program | This is the prescribed daily opioids confirmed from the PDMP. | Day of surgery (postoperative day 0), postoperative days 30, 90, 180, and 365 |
| Nausea and vomiting | Nausea and vomiting measured on the following scale: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective | Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365 |
| Constipation | Constipation: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective | Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365 |
| Pruritus | Puritus: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective | Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365 |
| Patient satisfaction with pain control | 0-10 scale with 0 being worst possible pain control and 10 being best possible pain control | Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365 |
| SF-12 | This is a brief assessment of physical and mental function | Baseline, day of surgery (postoperative day 0), and postoperative days 30, 90, 180, and 365 |
| Background |
| Hassamal S, Haglund M, Wittnebel K, Danovitch I. A preoperative interdisciplinary biopsychosocial opioid reduction program in patients on chronic opioid analgesia prior to spine surgery: A preliminary report and case series. Scand J Pain. 2016 Oct;13:27-31. doi: 10.1016/j.sjpain.2016.06.007. Epub 2016 Jul 4. |
| 35241626 | Background | Bicket MC, Gunaseelan V, Lagisetty P, Fernandez AC, Bohnert A, Assenmacher E, Sequeira M, Englesbe MJ, Brummett CM, Waljee JF. Association of opioid exposure before surgery with opioid consumption after surgery. Reg Anesth Pain Med. 2022 Jun;47(6):346-352. doi: 10.1136/rapm-2021-103388. Epub 2022 Mar 3. |
| 30973507 | Background | Kalakoti P, Volkmar AJ, Bedard NA, Eisenberg JM, Hendrickson NR, Pugely AJ. Preoperative Chronic Opioid Therapy Negatively Impacts Long-term Outcomes Following Cervical Fusion Surgery. Spine (Phila Pa 1976). 2019 Sep;44(18):1279-1286. doi: 10.1097/BRS.0000000000003064. |
| 28403427 | Background | Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. |
| 27400458 | Background | 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. doi: 10.1001/jamainternmed.2016.3298. |
| 32604353 | Background | Reyes AA, Canseco JA, Mangan JJ, Divi SN, Goyal DKC, Bowles DR, Patel PD, Salmons HI, Morgenstern M, Anderson DG, Rihn JA, Kurd MF, Hilibrand AS, Kepler CK, Vaccaro AR, Schroeder GD. Risk Factors for Prolonged Opioid Use and Effects of Opioid Tolerance on Clinical Outcomes After Anterior Cervical Discectomy and Fusion Surgery. Spine (Phila Pa 1976). 2020 Jul 15;45(14):968-975. doi: 10.1097/BRS.0000000000003511. |
| 30983591 | Background | Colvin LA, Bull F, Hales TG. Perioperative opioid analgesia-when is enough too much? A review of opioid-induced tolerance and hyperalgesia. Lancet. 2019 Apr 13;393(10180):1558-1568. doi: 10.1016/S0140-6736(19)30430-1. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |