A Pilot Study of the Feasibility of Preoperative Opioid Tapering Before Spine Surgery Using Cognitive Behavioral Therapy and Measuring Postoperative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- proportion that achieved opioid tapering goal
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Opioid tapering with Cognitive Behavioral Therapy (CBT) and education
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.
干预措施: Opioid tapering with CBT and education (Other)
Opioid tapering with education alone
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.
干预措施: Opioid tapering with education alone (Other)
结局指标
主要结局
proportion that achieved opioid tapering goal
时间窗: Perioperative prior to surgery (postoperative day 0)
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.
次要结局
- Brief Pain Inventory(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(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(Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365)
- Generalized Anxiety Disorder-2(Baseline)
- Columbia Suicide Screening Assessment(Screening period)
- Daily opioid use in hospital(Postoperative days 0-7)
- Hospital length of stay(Postoperative days 0-7)
- Quality of recovery-15(Preoperative baseline, postoperative days 1-2)
- Hospital Anxiety and Depression Scale(Postoperative days 0-3)
- Opioid use in daily OMEs(Day of surgery (postoperative day 0), postoperative days 30, 90, 180 and 365)
- Daily opioid use in OMEs from prescription drug monitoring program(Day of surgery (postoperative day 0), postoperative days 30, 90, 180, and 365)
- Nausea and vomiting(Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365)
- Constipation(Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365)
- Pruritus(Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365)
- Patient satisfaction with pain control(Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365)
- SF-12(Baseline, day of surgery (postoperative day 0), and postoperative days 30, 90, 180, and 365)
研究者
Eric Schwenk
Professor of Anesthesiology and Perioperative Medicine
Thomas Jefferson University