Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

Study Overview
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Brief Summary
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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.

Official Title
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Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion: A Randomized Controlled Study

Conditions
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Opioid Use, Spine Fusion

Intervention / Treatment
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* Behavioral: Spinal Fusion Preoperative Opioid Taper
* Other: Non-taper Control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid Taper Group<br>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<br>* Guided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.<br>|
| Active Comparator: Control Group<br>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<br>* Weekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Postoperative Opioid Pain Medication Dose | Weekly average opioid medication use in morphine equivalent dosage (MED) | Weekly, month 3, month 6 | 
| Change in Numeric Pain Scale Score | Generic measure of average back pain, scale 0-10 with 0 being no pain and 10 being the most pain experienced. | Weekly, month 3, month 6 | 
| Change from baseline Patient Reported Outcome Measures (PROMs) | PROMIS computer adaptive testing: global health, physical function, pain interference, pain behavior, depression, anxiety, fatigue, sleep disturbance, and satisfaction with social roles and activities. | Weekly, month 3, month 6 |