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Preoperative Opioid Tapering Before Spine Surgery

Preoperative Opioid Tapering Before Spine Surgery

Recruiting
18 years and older
All
Phase N/A

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Overview

This is a pilot study in which patients taking opioids chronically who are scheduled for spine surgery at least 4 weeks in advance will be randomly assigned to one of two groups: opioid tapering with education alone or opioid tapering with education plus cognitive behavioral therapy (CBT). The primary objective is to determine the proportion of each group that is successful in achieving their opioid tapering goals by the time of surgery.

Description

The perioperative period represents a particularly problematic time for opioid-dependent patients. Perioperative pain is often difficult to control, with opioid tolerance, opioid-induced hyperalgesia, and withdrawal making management a challenge. In addition to these short-term challenges, opioid-dependent patients experience poorer outcomes after surgery, including both early and late complications, emergency room visits, infections, and reoperations. Spine surgery in opioid-tolerant patients increases the risk for prolonged postoperative opioid use. This risk is in addition to the risk of prolonged opioid use that surgery itself introduces. The high prevalence of opioid use in spine patients makes spine surgery an ideal surgical model in which to study opioid tapering.

This is a randomized, controlled pilot study of 45 opioid-dependent patients undergoing spine surgery. Patients will be assigned in parallel to one of the following: 1. opioid tapering with education alone or 2. opioid tapering with education plus cognitive behavioral therapy (CBT). While all patients will meet with a pain physician to design a personalized tapering program, the CBT group will receive two CBT sessions prior to surgery. Pain, depression, anxiety, and opioid withdrawal will be assessed throughout the month prior to surgery and managed appropriately. Opioid use at the time of surgery will be assessed along with pain and depression and anxiety. Hospital outcomes, including pain, opioid use, quality of recovery, and postoperative complications, will be measured. Patients will be followed upon discharge by a chronic pain physician and patients assigned to CBT will receive one additional session after surgery. All patients will also be assessed via telephone call or Zoom at 30, 90, 180, and 365 days for pain, function, and opioid use.

Eligibility

Inclusion
  • at least 18 years old
  • scheduled for major spine surgery (i.e. at least 1 level of fusion) with hospital admission of at least one night
  • scheduled for spine surgery at least 4 weeks ahead of time
  • takes between 40 and 200 oral morphine equivalents daily
Exclusion
  • inability to use a computer or tablet for telemedicine encounters
  • non-English-speaking
  • inability to complete assessments
  • positive screen on the Columbia Suicide Screening Assessment

Study details
    Opioid Consumption
    Postoperative
    Pain After Surgery
    Opioid Dependency

NCT07221786

Thomas Jefferson University

15 May 2026

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