A Phase 2 interventional study of Duloxetine 60 MG and Placebo in Acute Post-operative Pain, Chronic Post Operative Pain and Narcotic Use, sponsored by Scripps Health. Terminated at 1 site in United States. Open to participants aged 24 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Scripps Health · Phase 2, Interventional, and Prevention
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 17 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Scripps Health is the lead sponsor of 45 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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
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
Looking at the use of duloxetine's effect with regards to perioperative narcotics consumption and patient outcomes after lumbar fusion.
Also known as: Drizalma Sprinkle, Cymbalta, Irenka
Duloxetine versus placebo in reducing postoperative narcotic consumption among patients undergoing lateral lumbar interbody fusions
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Patients to be evaluated at post-op at 8 weeks.
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