Insomnia, Osteo Arthritis Knee
Conditions
Brief summary
Use of mirtazapine and quetiapine for improvement of sleep quality after TKA
Detailed description
Background After knee replacement surgery there is a loss of quantity and quality of sleep. Loss of sleep is associated with increased pain perception. Subsequently, patients use more analgesic medication and it takes them longer to fully recover from surgery. Low doses of the tetracyclic antidepressant mirtazapine and the neuroleptic quetiapine are nowadays off-label prescribed for insomnia and improve length and quality of deep sleep phases. Quetiapine and mirtazapine could improve sleep after knee replacement surgery and improve patient recovery. This placebo-controlled, randomized, double-blind study investigates the effect of quetiapine and mirtazapine on functional recovery after total knee arthroplasty. Methods This is a prospective, single center, double-blinded randomized controlled trial. 165 patients with knee osteoarthritis scheduled for total knee arthroplasty will be randomly allocated to a low-dose quetiapine (LDQ), a low-dose mirtazapine (LDM) group or a placebo group. Outcomes will be evaluated at baseline, 2, 4, 6 and 12 weeks after surgery. Functional outcome after total knee arthroplasty is measured using a patient related outcome measure through the Oxford Knee Score (OKS). In order to measure postoperative sleep quality, patients will be monitored using the Leeds Sleep evaluation questionnaire (LSEQ). Furthermore, pain is registered using a visual analogue scale (VAS), weekly opioid use is monitored, and general health status is reported through the EQ-5D. Analyses will be conducted on an intention-to-treat basis using logistic and linear mixed regression models. This trial complies with the SPIRIT guidelines for randomized controlled trials. Discussion This study will provide clinicians with evidence whether quetiapine contributes to rehabilitation of patients undergoing fast-track knee replacement surgery.
Interventions
DRUGMirtazapine
Use of 3.75mg mirtazapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 7.5mg mirtazapine.
DRUGQuetiapine
Use of 3.125mg quetiapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 6.25mg mirtazapine.
DRUGPlacebo
a gelatinous capsule without an active ingredient
Sponsors
St. Anna Ziekenhuis, Geldrop, Netherlands
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo controlled trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Indication for TKA
Exclusion criteria
* use of benzodiazepines * use of anti-depressants * use of oxycodone * patients diagnosed with obstructive sleep apnea syndrome, severe respiratory insufficiency, or myasthenia * a known hypersensitivity to mirtazapine, quetiapine and/or related to the gelatinous (placebo) capsule * insufficient understanding of the Dutch language.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score (OKS) | 6 weeks after surgery | Validated functional knee score after TKA, minimum score 12 (best outcome), maximum score 60 (worst outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) for fatigue | 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery | Visual analogue reporting of fatigue after sleep, indicated on a 0 (best outcome) to 100 (worst outcome) mm line |
| Visual Analogue Scale (VAS) for sleep quality | 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery | Visual analogue reporting of quality sleep, indicated on a 0 (worst outcome) to 100 (best outcome) mm line |
| Visual Analogue Scale (VAS) for pain in rest | 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery | Visual analogue reporting of knee pain while resting, indicated on a 0 (best outcome) to 100 (worst outcome) mm line |
| Leeds Sleep Evaluation questionnaire (LSEQ) | 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery | Validated sleep score in 3 dimensions of sleep |
| EuroQol (EQ) 5D | 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery | General well being score, full health represented by 11111 score (overall score for the Netherlands of 1,000), worst health represented by 55555 score (overal score for the Netherlands of -0,329) |
| Morphine use | 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery | Total amount (mg) morphine use after surgery is documented |
| Oxford knee score | 1 week before surgery; first day postoperative; 2; 4; 12 weeks after surgery | Validated functional knee score after TKA, minimum score 12 (best outcome), maximum score 60 (worst outcome) |
| Visual Analogue Scale (VAS) for pain during activity | 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery | Visual analogue reporting of knee pain during exercises, indicated on a 0 (best outcome) to 100 (worst outcome) mm line |
Countries
Netherlands
Contacts
Primary ContactWalter van der Weegen
Backup ContactMichiel Siebelt
Outcome results
None listed