Duloxetine Impact on Postoperative Pain Control and Outcomes

Study Overview
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Brief Summary
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Evaluate differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative narcotic consumption. Evaluate differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain, function, and quality of life. 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
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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.

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

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

Intervention / Treatment
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* Drug: Duloxetine 60 MG
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group receiving a placebo<br>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. | Other: Placebo<br>* Duloxetine versus placebo in reducing postoperative narcotic consumption among patients undergoing lateral lumbar interbody fusions<br>|
| Experimental: treatment group receiving 60 mg Duloxetine<br>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. | Drug: Duloxetine 60 MG<br>* Looking at the use of duloxetine's effect with regards to perioperative narcotics consumption and patient outcomes after lumbar fusion.<br>* Other names: Irenka;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the amount of change in pain, for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion | Evaluate the effectiveness of Duloxetine versus placebo through the assessment of postoperative narcotic consumption. | 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. | 
| Measuring the amount of change in pain, for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion | Measure the differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain. | 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. | 
| Evaluating the amount of change in function for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion | Evaluate the effectiveness of Duloxetine versus placebo through the assessment of postoperative narcotic consumption. | 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. | 
| Measuring the amount of change in function for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion | Measure the differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain. | 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. | 
| Evaluating the amount of change in narcotic consumption for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion | Evaluate the effectiveness of Duloxetine versus placebo through the assessment of postoperative narcotic consumption. | 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. | 
| Measuring the amount of change in narcotic consumption for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion | Measure the differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain. | 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. | 
| Measuring the general domains of health with PROMIS Global questionnaire | The PROMIS Global questionnaire is a patient reported outcome that evaluates and identifies the life domains in areas such as physical, mental and social health. Scoring for the questionnaire is out of 50 points and the higher the score the healthier the patient. | Patients will be asked to complete the PROMIS Global at baseline visit | 
| Measuring the general domains of function with PROMIS Global questionnaire | The PROMIS Global questionnaire is a patient reported outcome that evaluates and identifies the life domains in areas such as physical, mental and social health. Scoring for the questionnaire is out of 50 points and the higher the score the healthier the patient. | Patients will be asked to complete the PROMIS Global at baseline visit | 
| Measuring the general domains of health with PROMIS Global questionnaire | The PROMIS Global questionnaire is a patient reported outcome that evaluates and identifies the life domains in areas such as physical, mental and social health. Scoring for the questionnaire is out of 50 points and the higher the score the healthier the patient. | Patients will be asked to complete the PROMIS Global at 2 week post-op visit | 
| Measuring the general domains of function with PROMIS Global questionnaire | The PROMIS Global questionnaire is a patient reported outcome that evaluates and identifies the life domains in areas such as physical, mental and social health. Scoring for the questionnaire is out of 50 points and the higher the score the healthier the patient. | Patients will be asked to complete the PROMIS Global at 2 week post-op visit | 
| Measuring the general domains of health with PROMIS Global questionnaire | The PROMIS Global questionnaire is a patient reported outcome that evaluates and identifies the life domains in areas such as physical, mental and social health. Scoring for the questionnaire is out of 50 points and the higher the score the healthier the patient. | Patients will be asked to complete the PROMIS Global at 4 week post-op visit | 
| Measuring the general domains of function with PROMIS Global questionnaire | The PROMIS Global questionnaire is a patient reported outcome that evaluates and identifies the life domains in areas such as physical, mental and social health. Scoring for the questionnaire is out of 50 points and the higher the score the healthier the patient. | Patients will be asked to complete the PROMIS Global at 4 week post-op visit | 
| Measuring the general domains of health with PROMIS Global questionnaire | The PROMIS Global questionnaire is a patient reported outcome that evaluates and identifies the life domains in areas such as physical, mental and social health. Scoring for the questionnaire is out of 50 points and the higher the score the healthier the patient. | Patients will be asked to complete the PROMIS Global at 8 week post-op visit | 
| Measuring the general domains of function with PROMIS Global questionnaire | The PROMIS Global questionnaire is a patient reported outcome that evaluates and identifies the life domains in areas such as physical, mental and social health. Scoring for the questionnaire is out of 50 points and the higher the score the healthier the patient. | Patients will be asked to complete the PROMIS Global at 8 week post-op visit | 
| Patient's anxiety symptoms severity at baseline visit | The Generalized Anxiety Disorder-7 (GAD-7) is an assessment tool to measure the changes in a treatments progress and provide guidance for treatment decisions, interventional targets and give assistance in differential diagnosis. Scoring for this measure is based off the patient reporting anxiety symptoms on a Likert scale. The scale scoring is rom 1- 21. The lower the score the less the severity of anxiety symptoms being reported by a patient. | Patients will be asked to complete the GAD-7 at the baseline visit | 
| Patient's anxiety symptoms severity at eight week visit | The Generalized Anxiety Disorder-7 (GAD-7) is an assessment tool to measure the changes in a treatments progress and provide guidance for treatment decisions, interventional targets and give assistance in differential diagnosis. Scoring for this measure is based off the patient reporting anxiety symptoms on a Likert scale. The scale scoring is rom 1- 21. The lower the score the less the severity of anxiety symptoms being reported by a patient. | Patients will be asked to complete the GAD-7 at the 8 week post-op visit. | 
| Measuring a patient's baseline visit for severity of depression symptoms with Beck's Depression Inventory | The Beck's Depression Inventory questionnaire is a patient self-reporting measurement of a patients symptoms and the related characteristic and attitudes pertaining to depression. This measure is cored on a scale 0-3 on 21 questions. The higher the score the worse the outcome is for the severity of depression. | Patient s will complete the Beck's Depression Inventory at the baseline visit. | 
| Measuring a patient's eight week visit for severity of depression symptoms with Beck's Depression Inventory | The Beck's Depression Inventory questionnaire is a patient self-reporting measurement of a patients symptoms and the related characteristic and attitudes pertaining to depression. This measure is cored on a scale 0-3 on 21 questions. The higher the score the worse the outcome is for the severity of depression. | Patient s will complete the Beck's Depression Inventory at the 8 week post-op visit. | 
| Measuring at the baseline of a patient's hypersensitivity to noxious and non-noxious stimuli with the Central Sensitization Inventory | The Central Sensitization inventory is a patient self reporting on the severity of their central sensitization pain they are experiencing. The pain severity is scored from 0-100 ( (subclinical= 0-29), (mild=30-39), (moderate=40-49), (severe= 50-59) and (extreme=60-100). The higher the score equates to the worse the outcome. | Patients will complete the Central Sensitization Inventory at the baseline visit. | 
| Measuring at eight weeks to evaluate a patient's hypersensitivity to noxious and non-noxious stimuli with the Central Sensitization Inventory | The Central Sensitization inventory is a patient self reporting on the severity of their central sensitization pain they are experiencing. The pain severity is scored from 0-100 ( (subclinical= 0-29), (mild=30-39), (moderate=40-49), (severe= 50-59) and (extreme=60-100). The higher the score equates to the worse the outcome. | Patients will complete the Central Sensitization Inventory at the 8 week post-op visit. | 
| Baseline to measure a patient's catastrophic thinking in relation to adults with or without chronic pain. | The Pain Catastrophizing Scale is measure that a patient self-reports their thoughts and feelings that may be associated to the pain that they may or may not be experiencing. The scoring of this scale is as follows: 0=not at all, 1=to a slight degree, 2=to a moderate degree, 3= to a great degree, 4= all the time. The higher the score equals the worse the outcome | The patient will complete the Pain Catastrophizing Scale at the baseline visit. | 
| Eight week measurement of a patient's catastrophic thinking in relation to adults with or without chronic pain. | The Pain Catastrophizing Scale is measure that a patient self-reports their thoughts and feelings that may be associated to the pain that they may or may not be experiencing. The scoring of this scale is as follows: 0=not at all, 1=to a slight degree, 2=to a moderate degree, 3= to a great degree, 4= all the time. The higher the score equals the worse the outcome | The patient will complete the Pain Catastrophizing Scale at the 8 week post-op visit. | 
| Two week evaluation of amount of change in post-op pain improvement | 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). Continued use of previously mentioned patient reported outcomes will be measured at the designated time points | Patients to be evaluated at post-op at 2 weeks. | 
| Four week evaluation of amount of change in post-op pain improvement | 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). Continued use of previously mentioned patient reported outcomes will be measured at the designated time points | Patients to be evaluated at post-op at 4 weeks. | 
| Eight week evaluataion of amount of change in post-op pain improvement | 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). Continued use of previously mentioned patient reported outcomes will be measured at the designated time points | Patients to be evaluated at post-op at 8 weeks. | 
| Two week evaluation of amount of change in post-op quality of life improvement | 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). Continued use of previously mentioned patient reported outcomes will be measured at the designated time points | Patients to be evaluated at post-op at 2 weeks | 
| Four week evaluation of amount of change in post-op quality of life improvement | 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). Continued use of previously mentioned patient reported outcomes will be measured at the designated time points | Patients to be evaluated at post-op at 4 weeks. | 
| Eight week evaluation of amount of change in post-op quality of life improvement | 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). Continued use of previously mentioned patient reported outcomes will be measured at the designated time points | Patients to be evaluated at post-op at 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute pain, Chronic pain, narcotic consumption, patient outcomes