NCT05611749

Duloxetine Impact on Postoperative Pain Control and Outcomes

Postoperative Duloxetine Impact on Pain Control and Patient Outcomes Following Lateral Lumbar Interbody Fusion: A Randomized Controlled Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Scripps Health · Academic / Other
• Sex: All
• Age: 24 Years – 99 Years
• Healthy volunteers: Accepted

Summary

1. Evaluate differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative narcotic consumption. 2. Evaluate differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain, function, and quality of life. 3. Evaluate the correlation between preoperative screening tests (measuring pain centralization, anxiety, depression, and overall function) and patients' response to treatment (reduction in pain, anxiety, or depression and improvement in function).

Detailed description

It is widely accepted that over-prescription of narcotics by medical providers has played a significant role in the recent uptick in the nationwide opioid crisis facing American society. As such, a tremendous amount of research within the surgical community has been dedicated to reducing the need for narcotics in the acute postoperative period. Anti-depressants, including tricyclics as well as selective serotonin inhibitors (both SSRIs and SNRIs), have been identified in several trials as having potential benefit for treating acute postoperative pain. Duloxetine (an SNRI) has been approved by the FDA for treating mental health conditions such as depression and anxiety as well as chronic musculoskeletal pain. Previous studies have established its efficacy in treating acute postoperative pain following orthopaedic procedures such as total joint arthroplasty, even with relatively short durations of treatment. Specifically, previous randomized controlled trials have demonstrated that perioperative duloxetine leads to decreased narcotics consumption as well as improved function scores in patients undergoing total knee arthroplasty. While there has been a fair amount of research within the arthroplasty literature, there is minimal research to date investigating the potential benefits of this medication in the spine literature. Lateral interbody fusion is a commonly performed procedure where an interbody spacer (typically made of either PEEK or titanium) is placed between two adjacent vertebrae. This is usually done with the goal of increasing the space between the bones and/or to fuse the two bones together, thereby reducing the amount of motion that occurs during activities of daily living. To this point, there has not been any studies looking at the use of duloxetine's effect with regards to perioperative narcotics consumption and patient outcomes after lumbar fusion.

Conditions

• Acute Post-operative Pain
• Chronic Post Operative Pain
• Narcotic Use
• Opioid Use
• Opioid Addiction

Interventions

Type	Name	Description
DRUG	Duloxetine 60 MG	Looking at the use of duloxetine's effect with regards to perioperative narcotics consumption and patient outcomes after lumbar fusion.
OTHER	Placebo	Duloxetine versus placebo in reducing postoperative narcotic consumption among patients undergoing lateral lumbar interbody fusions

Timeline

• Start date: 2023-05-30
• Primary completion: 2024-03-25
• Completion: 2024-03-25
• First posted: 2022-11-10
• Last updated: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study