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Duloxetine for Postoperative Pain After Knee Surgery

Phase 4
Recruiting
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
Any patient undergoing primary total knee arthroplasty for osteoarthritis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months following surgery
Awards & highlights

Study Summary

This trial will test whether duloxetine reduces pain and improves patient outcomes after knee surgery, compared to patients who don't receive the medication. If successful, duloxetine could become a standard pain medication for this type of surgery.

Who is the study for?
This trial is for adults under 80 years old who are having a knee replacement due to osteoarthritis and can speak English. They must be willing to follow the study plan and return for check-ups. People with severe health issues, mental disorders, heavy alcohol use, opioid tolerance, or kidney problems cannot join.Check my eligibility
What is being tested?
The trial tests if duloxetine reduces pain and opioid need after knee surgery compared to a placebo (a pill without medicine). It also looks at how it affects patient-reported outcomes. Participants will be randomly assigned to either receive duloxetine or a placebo.See study design
What are the potential side effects?
Duloxetine may cause nausea, dry mouth, sleepiness, constipation, fatigue and increased sweating. It might also affect mood and appetite. Not everyone will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am having a knee replacement due to arthritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months following surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative opioid consumption at post op day 14 (POD14)
Secondary outcome measures
Complications
Patient reported outcome: Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)
Patient reported outcome: Sleep duration and quality
+1 more

Side effects data

From 2012 Phase 4 trial • 291 Patients • NCT01118780
11%
Nausea
11%
Headache
9%
Constipation
8%
Dizziness
7%
Dry mouth
6%
Somnolence
5%
Diarrhoea
4%
Abdominal pain upper
4%
Fall
4%
Decreased appetite
4%
Pruritus
3%
Vertigo
3%
Hyperhidrosis
2%
Nasopharyngitis
1%
Hypertensive crisis
1%
Angina pectoris
1%
Back pain
1%
Insomnia
1%
Large intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duloxetine
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DuloxetineExperimental Treatment1 Intervention
Patients randomized to the experimental arm of the study will receive 30 mg of duloxetine and will be advised to consume the medication orally (per os [PO]) daily starting one week prior to surgery and to continue until 6 weeks following surgery. The dose of 30 mg was selected as that has been used as that is the largest starting dose used in other RCTs without requiring a preceding adjustment period at a lower dosage.
Group II: ControlPlacebo Group1 Intervention
Patients randomized to the control arm will receive PO-matched placebo tablets and advised to consume their medication similar to the treatment arm. Both groups of patients will receive their medications from the pharmacy at Rush Medical Center, which will be responsible for providing patients with the appropriate regimen. All patients will receive the same postoperative multimodal analgesic regimen that is normally administered as part of conventional care to patients undergoing TKA at Rush University Medical Center.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duloxetine
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
162,997 Total Patients Enrolled
2 Trials studying Postoperative Pain
327 Patients Enrolled for Postoperative Pain

Media Library

Placebos Clinical Trial Eligibility Overview. Trial Name: NCT05086393 — Phase 4
Postoperative Pain Research Study Groups: Control, Duloxetine
Postoperative Pain Clinical Trial 2023: Placebos Highlights & Side Effects. Trial Name: NCT05086393 — Phase 4
Placebos 2023 Treatment Timeline for Medical Study. Trial Name: NCT05086393 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment into this trial open to qualified participants?

"This clinical trial is accepting patient enrolment and has been listed on the clinicaltrials.gov site since November 1st 2021 with its most recent update occurring October 27th 2022."

Answered by AI

Could you provide an overview of any prior research projects regarding the use of Duloxetine?

"Presently, there are 22 research projects on Duloxetine, with 4 of them in Phase 3. Redwood City is the epicentre for this type of study; however, 781 medical centres across America have studies related to Duloxetine underway."

Answered by AI

Are there any adverse effects of taking Duloxetine regularly?

"Duloxetine's safety has been well-documented through clinical trials, thus its rating is 3 out of a possible maximum value. This drug has already been approved for market use as it is currently in Phase 4 development."

Answered by AI

How many test subjects are participating in this experiment?

"That is correct. Information available on clinicaltrials.gov indicates that the trial, which was published on November 1st 2021 and last modified on October 27th 2022, is presently enrolling participants for recruitment at one site with a total of 504 patients required."

Answered by AI

What criteria must potential participants meet to be eligible for this research project?

"To be considered, potential participants must exhibit post-operative pain and should fit within the 18 to 80 year old demographic. This research is recruiting 504 people in total."

Answered by AI

In what ways does Duloxetine alleviate symptoms?

"Duloxetine is often prescribed for chronic diabetic peripheral neuropathy, however its uses have been extended to include knee issues, major depressive disorder (MDD), and musculoskeletal system disorders."

Answered by AI

Are there any age restrictions for enrolling in this experiment?

"Those who wish to enrol in this medical trial must be aged 18 and above, but no more than 80."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Duloxetine RCT on Postop TKA Outcomes
Denis Nam, M.D., M.Sc 2021. "Duloxetine RCT on Postop TKA Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05086393.
All > Knee Replacement
~0 spots leftby May 2024
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