Opioid Consumption, Postoperative, Opioid Dependency, Pain After Surgery
Conditions
Keywords
spine surgery, pain management, opioids, opioid use, depression, anxiety, opioid dependence, opioid tapering, cognitive behavioral therapy
Brief summary
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.
Detailed description
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.
Interventions
OTHEROpioid 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.
OTHEROpioid 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.
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion that achieved opioid tapering goal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Brief Pain Inventory is a validated pain assessment tool that measures pain severity and its effects on daily function. |
| 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. | Standardized assessment of opioid withdrawal |
| Patient Health Questionnaire-9 | Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365 | Depression screening |
| Generalized Anxiety Disorder-2 | Baseline | Standardized generalized anxiety screening |
| Columbia Suicide Screening Assessment | Screening period | This is a suicide risk screening tool |
| Daily opioid use in hospital | Postoperative days 0-7 | This will be the average daily opioid use in the hospital |
| Hospital length of stay | Postoperative days 0-7 | Duration of hospital stay in days |
| Quality of recovery-15 | Preoperative baseline, postoperative days 1-2 | This is a validated 15-question assessment of quality of recovery |
| Hospital Anxiety and Depression Scale | Postoperative days 0-3 | Anxiety and depression assessment for the hospitalization |
| Opioid use in daily OMEs | Day of surgery (postoperative day 0), postoperative days 30, 90, 180 and 365 | Patient-reported daily opioid use on average in mg |
| Daily opioid use in OMEs from prescription drug monitoring program | Day of surgery (postoperative day 0), postoperative days 30, 90, 180, and 365 | This is the prescribed daily opioids confirmed from the PDMP. |
| Nausea and vomiting | Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365 | 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 |
| Constipation | Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365 | 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 |
| Pruritus | Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365 | 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 |
| Patient satisfaction with pain control | Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365 | 0-10 scale with 0 being worst possible pain control and 10 being best possible pain control |
| SF-12 | Baseline, day of surgery (postoperative day 0), and postoperative days 30, 90, 180, and 365 | This is a brief assessment of physical and mental function |
Countries
United States
Contacts
CONTACTEric Schwenk, MD
CONTACTJeffrey Mojica, DO
Outcome results
None listed