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Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

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ClinicalTrials.gov Identifier: NCT04095624
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Serena Hu, Stanford University

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
Opioid Use Spine Fusion Behavioral: Spinal Fusion Preoperative Opioid Taper Other: Non-taper Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion: A Randomized Controlled Study
Estimated Study Start Date : September 23, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Change in Postoperative Opioid Pain Medication Dose [ Time Frame: Weekly, month 3, month 6 ]
    Weekly average opioid medication use in morphine equivalent dosage (MED)

  2. Change in Numeric Pain Scale Score [ Time Frame: 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.

  3. Change from baseline Patient Reported Outcome Measures (PROMs) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Additional Information:
Publications:

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Responsible Party: Serena Hu, Professor of Orthopaedic Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT04095624     History of Changes
Other Study ID Numbers: 47240
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Analgesics, Opioid
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents