Acute Post-operative PainPhase 2NCT05611749
Duloxetine Impact on Postoperative Pain Control and Outcomes
A Phase 2 study testing Duloxetine 60 MG in people with Acute Post-operative Pain and Chronic Post Operative Pain, run by Scripps Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Post-operative Pain, Chronic Post Operative Pain, Narcotic Use
- What is being tested?
- Duloxetine 60 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2023to 25 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: > 24 years
- Male / Female not meeting any of the exclusion criteria
Who cannot join
- 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
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- History of suicidal ideation
- History of liver disease
- History of chronic kidney disease/renal impairment
- History of angle-closure glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Clinic Torrey Pines
La Jolla, California, 92037
About this study
Official title: Postoperative Duloxetine Impact on Pain Control and Patient Outcomes Following Lateral Lumbar Interbody Fusion: A Randomized Controlled Trial
- 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).
Read the 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
- Being tested
- Duloxetine 60 MG, Placebo
- Keywords
- Acute pain, Chronic pain, narcotic consumption, patient outcomes
- Medical subject headings
- Pain, Postoperative, Opioid-Related Disorders, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine 60 MGDrug
Also called Drizalma Sprinkle, Cymbalta, Irenka
Looking at the use of duloxetine's effect with regards to perioperative narcotics consumption and patient outcomes after lumbar fusion.
PlaceboOther
Duloxetine versus placebo in reducing postoperative narcotic consumption among patients undergoing lateral lumbar interbody fusions
| Study group | Role | What they receive |
|---|---|---|
| control group receiving a placebo | Placebo comparator | 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. Receives: Other: Placebo |
| treatment group receiving 60 mg Duloxetine | Experimental | 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. Receives: Drug: Duloxetine 60 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Patients to be evaluated at post-op at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start30 May 2023
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Why it stopped: Enrollment was extremely low and there were too many adverse events.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory M. Mundis Jr., MD, Scripps Health
- Investigators
- Gregory M Mundis, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611749
- Sponsor's protocol ID
- IRB-21-7830
- Status last verified
- Apr 2025
- First submitted
- 2 Aug 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Duloxetine Impact on Pain Control and Patient Outcomes Following Lateral Lumbar Interbody Fusion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05611749
- Acronym / sponsor ID
- IRB-21-7830
- Conditions
- Acute Post-operative Pain, Chronic Post Operative Pain, Narcotic Use, Opioid Use, Opioid Addiction
- Keywords
- Acute pain, Chronic pain, narcotic consumption, patient outcomes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was extremely low and there were too many adverse events.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group receiving a placebo | Placebo comparator | Other: PlaceboThe 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 group receiving 60 mg Duloxetine | Experimental | Drug: Duloxetine 60 MGThe 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. |
Who may qualify
- Ages
- 24 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: > 24 years
- Male / Female not meeting any of the exclusion criteria
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duloxetine 60 MGAlso: Drizalma Sprinkle, Cymbalta, IrenkaLooking at the use of duloxetine's effect with regards to perioperative narcotics consumption and patient outcomes after lumbar fusion. | Drug | treatment group receiving 60 mg Duloxetine |
| PlaceboDuloxetine versus placebo in reducing postoperative narcotic consumption among patients undergoing lateral lumbar interbody fusions | Other | control group receiving a placebo |
Primary outcome
Evaluating the amount of change in pain, for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
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.
Evaluate the effectiveness of Duloxetine versus placebo through the assessment of postoperative narcotic consumption.
Measuring the amount of change in pain, for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
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.
Measure the differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain.
Evaluating the amount of change in function for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
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.
Evaluate the effectiveness of Duloxetine versus placebo through the assessment of postoperative narcotic consumption.
Measuring the amount of change in function for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
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.
Measure the differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain.
Evaluating the amount of change in narcotic consumption for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
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.
Evaluate the effectiveness of Duloxetine versus placebo through the assessment of postoperative narcotic consumption.
Measuring the amount of change in narcotic consumption for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion
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.
Measure the differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain.
Measuring the general domains of health with PROMIS Global questionnaire
Time frame: Patients will be asked to complete the PROMIS Global at baseline visit
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.
Measuring the general domains of function with PROMIS Global questionnaire
Time frame: Patients will be asked to complete the PROMIS Global at baseline visit
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.
Measuring the general domains of health with PROMIS Global questionnaire
Time frame: Patients will be asked to complete the PROMIS Global at 2 week post-op visit
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.
Measuring the general domains of function with PROMIS Global questionnaire
Time frame: Patients will be asked to complete the PROMIS Global at 2 week post-op visit
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.
Measuring the general domains of health with PROMIS Global questionnaire
Time frame: Patients will be asked to complete the PROMIS Global at 4 week post-op visit
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.
Measuring the general domains of function with PROMIS Global questionnaire
Time frame: Patients will be asked to complete the PROMIS Global at 4 week post-op visit
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.
Measuring the general domains of health with PROMIS Global questionnaire
Time frame: Patients will be asked to complete the PROMIS Global at 8 week post-op visit
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.
Measuring the general domains of function with PROMIS Global questionnaire
Time frame: Patients will be asked to complete the PROMIS Global at 8 week post-op visit
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.
Patient's anxiety symptoms severity at baseline visit
Time frame: Patients will be asked to complete the GAD-7 at the 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.
Patient's anxiety symptoms severity at eight week visit
Time frame: Patients will be asked to complete the GAD-7 at the 8 week post-op 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.
Measuring a patient's baseline visit for severity of depression symptoms with Beck's Depression Inventory
Time frame: Patient s will complete the Beck's Depression Inventory at the baseline visit.
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.
Measuring a patient's eight week visit for severity of depression symptoms with Beck's Depression Inventory
Time frame: Patient s will complete the Beck's Depression Inventory at the 8 week post-op visit.
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.
Measuring at the baseline of a patient's hypersensitivity to noxious and non-noxious stimuli with the Central Sensitization Inventory
Time frame: Patients will complete the Central Sensitization Inventory at the baseline visit.
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.
Measuring at eight weeks to evaluate a patient's hypersensitivity to noxious and non-noxious stimuli with the Central Sensitization Inventory
Time frame: Patients will complete the Central Sensitization Inventory at the 8 week post-op visit.
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.
Baseline to measure a patient's catastrophic thinking in relation to adults with or without chronic pain.
Time frame: The patient will complete the Pain Catastrophizing Scale at the baseline visit.
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
Eight week measurement of a patient's catastrophic thinking in relation to adults with or without chronic pain.
Time frame: The patient will complete the Pain Catastrophizing Scale at the 8 week post-op visit.
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
Two week evaluation of amount of change in post-op pain improvement
Time frame: Patients to be evaluated at post-op at 2 weeks.
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
Four week evaluation of amount of change in post-op pain improvement
Time frame: Patients to be evaluated at post-op at 4 weeks.
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
Eight week evaluataion of amount of change in post-op pain improvement
Time frame: Patients to be evaluated at post-op at 8 weeks.
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
Two week evaluation of amount of change in post-op quality of life improvement
Time frame: Patients to be evaluated at post-op at 2 weeks
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
Four week evaluation of amount of change in post-op quality of life improvement
Time frame: Patients to be evaluated at post-op at 4 weeks.
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
Eight week evaluation of amount of change in post-op quality of life improvement
Time frame: Patients to be evaluated at post-op at 8 weeks.
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
Results and safety
The study was stopped early (reason given: Enrollment was extremely low and there were too many adverse events.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory M Mundis, MD principal investigator
Scripps Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine 60 MG in people with Acute Post-operative Pain and Chronic Post Operative Pain, run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment was extremely low and there were too many adverse events.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the amount of change in pain, for patients prescribed Duloxetine versus those patients prescribed the placebo following lateral lumbar interbody fusion (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.). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.