Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

Not Applicable

• Conditions: Spine Fusion; Opioid Use
• Interventions: Other: Non-taper Control; Behavioral: Spinal Fusion Preoperative Opioid Taper

• Registration Number: NCT04095624
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-03
• Study Start: 2019-09-09
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-19
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-10
• Last Update Posted: 2022-07-12
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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

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Exclusion Criteria

• Suboxone (buprenorphine) use
• Unable to complete patient reported outcome measures (PROMs)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Non-taper Control	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.
Opioid Taper Group	Spinal Fusion Preoperative Opioid Taper	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.

Primary Outcome Measures

Name	Time	Method
Change in Postoperative Opioid Pain Medication Dose	Weekly, month 3, month 6	Weekly average opioid medication use in morphine equivalent dosage (MED)
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.
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.

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Redwood City, California, United States