Doxepin Versus Doxepin and Ramelteon Versus Placebo to Improve Sleep Quality After Primary Total Knee Arthroplasty: A Randomized Controlled Trial
University of Washington
Summary
Many patients experience poor sleep during recovery after total knee arthroplasty (TKA). Disturbed sleep can last weeks to months and may worsen pain, slow healing, and reduce overall quality of life. Few safe, effective, evidence-based options exist to improve sleep during this recovery period. This study aims to determine whether the medications doxepin, either alone or in combination with ramelteon, can improve sleep quality during early recovery after TKA. The investigators will also evaluate whether improved sleep leads to better pain control, knee function, and overall quality of life.
Description
This randomized, placebo-controlled clinical trial seeks to answer the following question: Is doxepin or combination therapy consisting of doxepin plus ramelteon superior to placebo in terms of (1) sleep quality as measured by the Insomnia Severity Index, (2) postoperative knee function as measured by KOOS-JR, KOOS-PS, or (3) overall health-related quality of life during the first three months after total knee arthroplasty.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Those receiving primary total knee arthroplasty (TKA) * 80 years or less, age 18 or greater Exclusion Criteria: * History of cardiovascular bundle branch block * Actively taking selecrtive serotoin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), or having treatment via counseling/psychotherapy for major depression or anxiety, bipolar, or psychotic disorder * Pre-operative narcotics (defined as more than 1 prescription in the past 3 months) * Self-reported use of alcohol in excess of \>2 drinks/day…
Interventions
- DrugDoxepin 6 mg
Doxepin 6 mg administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty
- DrugRamelteon 8 mg
Ramelteon 8 mg administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty
- DrugPlacebo Tablets
Placebo administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty
Location
- University of Washington Medical Center Hip & Knee CenterSeattle, Washington