Duloxetine Impact on Postoperative Pain Control and Outcomes

Scripps Health

Status and phase: Not yet enrolling; Phase 2

Conditions: Chronic Post Operative Pain; Opioid Addiction; Opioid Use; Acute Post-operative Pain; Narcotic Use

Treatments: Drug: Duloxetine 60 MG; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05611749

IRB-21-7830

Details and patient eligibility

About

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).

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 24 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: > 24 years
• Male / Female not meeting any of the exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

control group receiving a placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

treatment group receiving 60 mg Duloxetine

Experimental group

Description:

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.

Treatment:

Drug: Duloxetine 60 MG