Preoperative Opioid Tapering Before Spine Surgery

Официальное название

A Pilot Study of the Feasibility of Preoperative Opioid Tapering Before Spine Surgery Using Cognitive Behavioral Therapy and Measuring Postoperative Outcomes

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Opioid tapering with CBT and education
  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.
• Другое Opioid tapering with education alone
  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.

Первичные конечные точки

• proportion that achieved opioid tapering goal [Срок оценки: Perioperative prior to surgery (postoperative day 0)]

Вторичные конечные точки (12)

• Brief Pain Inventory [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365]
• Generalized Anxiety Disorder-2 [Срок оценки: Baseline]
• Columbia Suicide Screening Assessment [Срок оценки: Screening period]
• Daily opioid use in hospital [Срок оценки: Postoperative days 0-7]
• Hospital length of stay [Срок оценки: Postoperative days 0-7]
• Quality of recovery-15 [Срок оценки: Preoperative baseline, postoperative days 1-2]
• Hospital Anxiety and Depression Scale [Срок оценки: Postoperative days 0-3]
• Opioid use in daily OMEs [Срок оценки: Day of surgery (postoperative day 0), postoperative days 30, 90, 180 and 365]
• Daily opioid use in OMEs from prescription drug monitoring program [Срок оценки: Day of surgery (postoperative day 0), postoperative days 30, 90, 180, and 365]
• Nausea and vomiting [Срок оценки: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365]

Критерии участия

Inclusion:

• at least 18 years old
• scheduled for major spine surgery (i.e. at least 1 level of fusion) with hospital admission of at least one night
• scheduled for spine surgery at least 4 weeks ahead of time
• takes between 40 and 200 oral morphine equivalents daily

Exclusion:

• inability to use a computer or tablet for telemedicine encounters
• non-English-speaking
• inability to complete assessments
• positive screen on the Columbia Suicide Screening Assessment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Thomas Jefferson University Hospital — Philadephia

Публикации

• 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 Op PMID 34398206
• 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. PMID 28850531
• 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. PMID 35241626
• 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. PMID 30973507
• 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. PMID 28403427
• 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. PMID 27400458
• 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.000 PMID 32604353
• 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. PMID 30983591

Идентификаторы

NCT: NCT07221786 · IRB Control #22D.843_JT#25484

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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