NCT07221786

Preoperative Opioid Tapering Before Spine Surgery

A Pilot Study of the Feasibility of Preoperative Opioid Tapering Before Spine Surgery Using Cognitive Behavioral Therapy and Measuring Postoperative Outcomes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Opioid Consumption, Postoperative
• Pain After Surgery
• Opioid Dependency

Interventions

Type	Name	Description
OTHER	Opioid tapering with CBT and education	Patients in the opioid tapering plus CBT group will set up an initial meeting with the pain physician within a few days of enrollment to set the tapering schedule. They will also have two CBT appointments set up to complete via telemedicine during the time between enrollment and surgery.
OTHER	Opioid tapering with education alone	Patients in this group will be instructed to continue their opioids at the same doses and frequencies they were taking up through the day of surgery. They will set up an initial meeting within a few days of enrollment with the chronic pain physician to determine the tapering schedule which will occur over 4 weeks or more leading into surgery. The patient and pain physician will collectively agree on a tapering schedule.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-10-28
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States