Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

NCT04095624 | Completed

• 1 other identifier: 47240
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Spine Fusion

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Opioid Taper Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Spinal Fusion Preoperative Opioid Taper BEHAVIORAL

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

Opioid Taper Group

Non-taper Control OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Redwood City, California, 94063, United States

Location

Related Publications (16)

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Study Officials

• Serena Hu, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: September 19, 2019
• Study Start: September 9, 2019
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 11, 2025

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)