Clinical trial NCT05611749: Duloxetine Impact on Postoperative Pain Control and Outcomes
Official title: Postoperative Duloxetine Impact on Pain Control and Patient Outcomes Following Lateral Lumbar Interbody Fusion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Post-operative Pain
Chronic Post Operative Pain
Narcotic Use
Opioid Use
Opioid Addiction
Keywords: Acute pain
Chronic pain
narcotic consumption
patient outcomes
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 17
Sex: ALL
Minimum age (years): 24
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either a control group receiving a placebo (n=65) or a treatment group receiving 60 mg Duloxetine (a selective serotonin and norepinephrine reuptake inhibitor) (n=65). Surgeons, patients, research staff, PACU staff, and floor staff will be blinded to group allocation.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluating the amount of change in pain, for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
timeFrame: The study medication (either placebo or Duloxetine) will be continued throughout the duration of hospitalization. Remaining pills will be provided to the patient as a discharge prescription to allow for 10 days total treatment.
measure: Measuring the amount of change in pain, for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
timeFrame: The study medication (either placebo or Duloxetine) will be continued throughout the duration of hospitalization. Remaining pills will be provided to the patient as a discharge prescription to allow for 10 days total treatment.
measure: Evaluating the amount of change in function for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
timeFrame: The study medication (either placebo or Duloxetine) will be continued throughout the duration of hospitalization. Remaining pills will be provided to the patient as a discharge prescription to allow for 10 days total treatment.
measure: Measuring the amount of change in function for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
timeFrame: The study medication (either placebo or Duloxetine) will be continued throughout the duration of hospitalization. Remaining pills will be provided to the patient as a discharge prescription to allow for 10 days total treatment.
measure: Evaluating the amount of change in narcotic consumption for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
timeFrame: The study medication (either placebo or Duloxetine) will be continued throughout the duration of hospitalization. Remaining pills will be provided to the patient as a discharge prescription to allow for 10 days total treatment.
measure: Measuring the amount of change in narcotic consumption for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
timeFrame: The study medication (either placebo or Duloxetine) will be continued throughout the duration of hospitalization. Remaining pills will be provided to the patient as a discharge prescription to allow for 10 days total treatment.
measure: Measuring the general domains of health with PROMIS Global questionnaire
timeFrame: Patients will be asked to complete the PROMIS Global at baseline visit
measure: Measuring the general domains of function with PROMIS Global questionnaire
timeFrame: Patients will be asked to complete the PROMIS Global at baseline visit
measure: Measuring the general domains of health with PROMIS Global questionnaire
timeFrame: Patients will be asked to complete the PROMIS Global at 2 week post-op visit
measure: Measuring the general domains of function with PROMIS Global questionnaire
timeFrame: Patients will be asked to complete the PROMIS Global at 2 week post-op visit
measure: Measuring the general domains of health with PROMIS Global questionnaire
timeFrame: Patients will be asked to complete the PROMIS Global at 4 week post-op visit
measure: Measuring the general domains of function with PROMIS Global questionnaire
timeFrame: Patients will be asked to complete the PROMIS Global at 4 week post-op visit
measure: Measuring the general domains of health with PROMIS Global questionnaire
timeFrame: Patients will be asked to complete the PROMIS Global at 8 week post-op visit
measure: Measuring the general domains of function with PROMIS Global questionnaire
timeFrame: Patients will be asked to complete the PROMIS Global at 8 week post-op visit
measure: Patient's anxiety symptoms severity at baseline visit
timeFrame: Patients will be asked to complete the GAD-7 at the baseline visit
measure: Patient's anxiety symptoms severity at eight week visit
timeFrame: Patients will be asked to complete the GAD-7 at the 8 week post-op visit.
measure: Measuring a patient's baseline visit for severity of depression symptoms with Beck's Depression Inventory
timeFrame: Patient s will complete the Beck's Depression Inventory at the baseline visit.
measure: Measuring a patient's eight week visit for severity of depression symptoms with Beck's Depression Inventory
timeFrame: Patient s will complete the Beck's Depression Inventory at the 8 week post-op visit.
measure: Measuring at the baseline of a patient's hypersensitivity to noxious and non-noxious stimuli with the Central Sensitization Inventory
timeFrame: Patients will complete the Central Sensitization Inventory at the baseline visit.
measure: Measuring at eight weeks to evaluate a patient's hypersensitivity to noxious and non-noxious stimuli with the Central Sensitization Inventory
timeFrame: Patients will complete the Central Sensitization Inventory at the 8 week post-op visit.
measure: Baseline to measure a patient's catastrophic thinking in relation to adults with or without chronic pain.
timeFrame: The patient will complete the Pain Catastrophizing Scale at the baseline visit.
measure: Eight week measurement of a patient's catastrophic thinking in relation to adults with or without chronic pain.
timeFrame: The patient will complete the Pain Catastrophizing Scale at the 8 week post-op visit.
measure: Two week evaluation of amount of change in post-op pain improvement
timeFrame: Patients to be evaluated at post-op at 2 weeks.
measure: Four week evaluation of amount of change in post-op pain improvement
timeFrame: Patients to be evaluated at post-op at 4 weeks.
measure: Eight week evaluataion of amount of change in post-op pain improvement
timeFrame: Patients to be evaluated at post-op at 8 weeks.
measure: Two week evaluation of amount of change in post-op quality of life improvement
timeFrame: Patients to be evaluated at post-op at 2 weeks
measure: Four week evaluation of amount of change in post-op quality of life improvement
timeFrame: Patients to be evaluated at post-op at 4 weeks.
measure: Eight week evaluation of amount of change in post-op quality of life improvement
timeFrame: Patients to be evaluated at post-op at 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
Study officials:
affiliation: Scripps Health
name: Gregory M Mundis, MD
role: PRINCIPAL_INVESTIGATOR
References: