Duloxetine Impact on Postoperative Pain Control and Outcomes

NCT05611749 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: IRB-21-7830
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Evaluate differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative narcotic consumption.
2. 2.Evaluate differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain, function, and quality of life.
3. 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).

Conditions

Acute Post-operative Pain; Chronic Post Operative Pain; Narcotic Use; Opioid Use; Opioid Addiction

Keywords

Acute pain; Chronic pain; narcotic consumption; patient outcomes

Outcome Measures

Primary Outcomes (28)

• 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.

Study Arms (2)

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.

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.

Drug: Duloxetine 60 MG

Interventions

Duloxetine 60 MG DRUG

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

treatment group receiving 60 mg Duloxetine

Placebo OTHER

Duloxetine versus placebo in reducing postoperative narcotic consumption among patients undergoing lateral lumbar interbody fusions

control group receiving a placebo

Eligibility Criteria

• Age: 24 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: \> 24 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (1)

Scripps Clinic Torrey Pines

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Opioid-Related Disorders; Acute Pain; Chronic Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gregory M Mundis, MD

  Scripps Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized on the day of surgery in the preoperative area by the investigational pharmacist, who will be the only staff unblinded. 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 via 'Meds to Beds.'
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric and Adult Spinal Deformity Surgery Co-Director San Diego Spine Fellowship Scripps Clinic Division of Orthopedic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: November 10, 2022
• Study Start: May 30, 2023
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

US (1)