Duloxetine Impact on Postoperative Pain Control and Outcomes

NCT ID: NCT05611749

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2024-03-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

control group receiving a placebo

The study medication (either placebo or Duloxetine) will be continued throughout the duration of hospitalization. The balance of the remaining pills will be provided to the patient as a discharge prescription to allow for 10 days total treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Duloxetine versus placebo in reducing postoperative narcotic consumption among patients undergoing lateral lumbar interbody fusions

treatment group receiving 60 mg Duloxetine

The study medication (either placebo or Duloxetine) will be continued throughout the duration of hospitalization. The balance of the remaining pills will be provided to the patient as a discharge prescription to allow for 10 days total treatment.

Group Type: EXPERIMENTAL

Duloxetine 60 MG

Intervention Type: DRUG

Looking at the use of duloxetine's effect with regards to perioperative narcotics consumption and patient outcomes after lumbar fusion.

Interventions

Duloxetine 60 MG

Looking at the use of duloxetine's effect with regards to perioperative narcotics consumption and patient outcomes after lumbar fusion.

Intervention Type: DRUG

Placebo

Duloxetine versus placebo in reducing postoperative narcotic consumption among patients undergoing lateral lumbar interbody fusions

Intervention Type: OTHER

Other Intervention Names

Drizalma Sprinkle; Cymbalta; Irenka

Eligibility Criteria

Inclusion Criteria

• Age: > 24 years

Exclusion Criteria

• Age < 24 years
• Current use of antidepressant medications (including SSRI/SNRI, tricyclic, or Monoamine Oxidase Inhibitors)
• History of seizure disorder
• Diagnosis of bipolar disorder
• History of syncope/orthostatic hypotension
• Diagnosis of any condition with slowed gastric emptying
• History of suicidal ideation
• History of liver disease
• History of chronic kidney disease/renal impairment
• History of angle-closure glaucoma.

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scripps Health

OTHER

Sponsor Role: lead

Responsible Party

Gregory M. Mundis Jr., MD

Pediatric and Adult Spinal Deformity Surgery Co-Director San Diego Spine Fellowship Scripps Clinic Division of Orthopedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory M Mundis, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Health

Locations

Scripps Clinic Torrey Pines

La Jolla, California, United States

Countries

United States

Other Identifiers

IRB-21-7830

Identifier Type: -

Identifier Source: org_study_id