Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Opioid Taper Group Patients randomized to the taper group will have baseline pain score, opioid medication use, and patient reported outcomes 4-6 weeks prior to elective thoracolumbar, lumbar, or lumbosacral spinal fusion surgery. They will receive a scheduled tapering protocol, with a goal of 10-15% reduction in their weekly opioid use, along with weekly phone calls from a study coordinator assessing their ability to taper and pain scores. After surgery, they will receive 6 weekly phone calls from the coordinator, to assess their postoperative opioid medication use and pain scores. At the 6th week phone call, and 3 month and 6 month clinic postoperative clinic visits, they will also repeat patient reported outcome measures. |
Behavioral: Spinal Fusion Preoperative Opioid Taper
Guided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.
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Active Comparator: Control Group Patients randomized to the control group will have baseline pain score, opioid medication use, and patient reported outcomes 4-6 weeks prior to elective thoracolumbar, lumbar, or lumbosacral spinal fusion surgery. They will receive no recommendation or guidance in their preoperative opioid pain medication use, but will received weekly phone calls from a study coordinator assessing their preoperative pain scores. After surgery, they will receive 6 weekly phone calls from the coordinator, to assess their postoperative opioid medication use and pain scores. At the 6th week phone call, and 3 month and 6 month clinic postoperative clinic visits, they will also repeat patient reported outcome measures. |
Other: Non-taper Control
Weekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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Indicated for lumbar, lumbosacral, or thoracolumbar spinal fusion surgery in the departments of Orthopedic Surgery and Neurosurgery
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Daily opioid use for at least 4 weeks prior to the preoperative planning appointment
Exclusion Criteria:
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Suboxone (buprenorphine) use
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Unable to complete patient reported outcome measures (PROMs)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Stanford Hospital and Clinics | Redwood City | California | United States | 94063 |
Sponsors and Collaborators
- Stanford University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
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