A Prospective, Triple-Blind, Randomized Controlled Trial Evaluating Duloxetine on Post-Operative Outcomes Following Primary Total Knee Arthroplasty in Patients With and Without Central Sensitization
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The aim of this study is to determine if duloxetine is associated with differences in post-operative pain, patient-reported outcome measures, and opioid consumption in patients undergoing primary total knee arthroplasty compared to patients who do not receive the medication. If so, duloxetine has the potential to become widely incorporated into the multi-modal analgesic regimen given to patients following knee replacements.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:
• Any patient undergoing primary total knee arthroplasty for osteoarthritis
• Age ≥ 18 years old
• Willingness to undergo randomization and return for all scheduled visits
• English speaking
Locations
United States
Illinois
Rush University medical Center
RECRUITING
Chicago
Contact Information
Primary
Denis Nam, MD, MSc
denis.nam@rushortho.com
(312)432-2468
Backup
Anne DeBenedetti, BA
anne.debenedetti@rushortho.com
(312)432-2468
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2025-11-15
Participants
Target number of participants: 504
Treatments
Experimental: Duloxetine
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.
Placebo_comparator: Control
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.
Related Therapeutic Areas
Sponsors
Leads: Rush University Medical Center