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Completed

NCT Number: NCT04095624

Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

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.

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Key information

Conditions

Opioid Use Spine Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Hospital and Clinics

Redwood City, California, 94063, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Spinal Fusion Preoperative Opioid Taper

Behavioral

Guided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.

Non-taper Control

Other

Weekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2019
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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