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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05611749
Other study ID # IRB-21-7830
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date November 15, 2022
Est. completion date September 30, 2024

Study information

Verified date November 2022
Source Scripps Health
Contact Tina L Iannacone, MPH
Phone 858-554-7124
Email Iannacone.Tina@scrippshealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Years to 99 Years
Eligibility 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.

Study Design


Intervention

Drug:
Duloxetine 60 MG
Looking at the use of duloxetine's effect with regards to perioperative narcotics consumption and patient outcomes after lumbar fusion.
Other:
Placebo
Duloxetine versus placebo in reducing postoperative narcotic consumption among patients undergoing lateral lumbar interbody fusions

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Scripps Health

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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
Primary 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.
Primary 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.
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