Opioid Use, Spine Fusion
Conditions
Brief summary
In light of the current opioid epidemic, there is an urgent need to address chronic opioid use prior to surgery before it is exacerbated by postoperative surgical pain. Our central hypothesis is that patients who taper their opioid use prior to surgery will have reduced postoperative opioid and pain medication usage, less postoperative pain, and improved patient reported outcomes relative to patients that do not taper prior to surgery. Our specific aims include: 1. Determine whether reducing patients' preoperative opioid usage through a structured tapering regimen reduces postoperative opioid and pain medication use. 2. Examine whether reducing patients' preoperative opioid usage through a structured tapering regimen reduces postoperative pain. 3. Determine whether reducing patients' preoperative opioid usage through a structured tapering regimen improves patient reported outcomes.
Interventions
BEHAVIORALSpinal Fusion Preoperative Opioid Taper
Guided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.
OTHERNon-taper Control
Weekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Indicated for lumbar, lumbosacral, or thoracolumbar spinal fusion surgery in the departments of Orthopedic Surgery and Neurosurgery * Daily opioid use for at least 4 weeks prior to the preoperative planning appointment
Exclusion criteria
* Suboxone (buprenorphine) use * Unable to complete patient reported outcome measures (PROMs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postoperative Opioid Pain Medication Dose | Weekly, month 3, month 6 | Weekly average opioid medication use in morphine equivalent dosage (MED) |
| Change in Numeric Pain Scale Score | Weekly, month 3, month 6 | Generic measure of average back pain, scale 0-10 with 0 being no pain and 10 being the most pain experienced. |
| Change from baseline Patient Reported Outcome Measures (PROMs) | Weekly, month 3, month 6 | PROMIS computer adaptive testing: global health, physical function, pain interference, pain behavior, depression, anxiety, fatigue, sleep disturbance, and satisfaction with social roles and activities. |
Countries
United States
Outcome results
None listed