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Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

NCT04095624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-04-11

No results posted yet for this study

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

Interventions

BEHAVIORAL

Spinal Fusion Preoperative Opioid Taper

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

OTHER

Non-taper Control

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

Sponsors & Collaborators

Principal Investigators

  • Serena Hu, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04095624 on ClinicalTrials.gov