Central Sensitisation, Central Sensitization, Osteoarthritis of Knee
Conditions
Keywords
Duloxetine, Total knee arthroplasty, Analgesic, Central sensitisation, Pain, SNRI, Chronic
Brief summary
Analgesic effect of 20mg Duloxetine was evaluated at regular short term intervals in patients without central sensitivity and undergoing bilateral single sitting total knee arthroplasty for tricompartmental osteoarthritis using standardised patient related outcome measures like the visual analogue score.
Detailed description
Patients who underwent bilateral, single-sitting total knee arthroplasty for tricompartmental knee osteoarthritis were evaluated preoperatively for having central sensitivity. Only patients without central sensitisation were recruited and randomised into two groups with one group given 20 mg duloxetine capsules and the other group given a starch capsule of same shape, make, and weight as a placebo. Patients were evaluated for pain at rest and movement using VAS. A 6-hourly calculation of VAS was done over the first 48 hours and the average was recorded. Subsequent measurements at 1 week, 2 weeks, 4 weeks, and 3 months after surgery was done by a blinded clinician. Additional, drug safety, NSAID consumption and overall patient satisfaction were studied.
Interventions
Only patients who underwent single bilateral Total knee arthroplasty and WITHOUT central sensitisation were evaluated
DRUGPlacebo
starch capsules identical in appearance and weight to the duloxetine capsules
Sponsors
The Grant Medical College & Sir J.J. Group of Hospitals
Orthopaedic Arthroscopy Knee and Shoulder Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Bilateral tricompartmental knee osteoarthritis * Underwent primary, bilateral TKA in single-sitting
Exclusion criteria
* American Society of Anesthesiologists physical status IV * Hamilton Depression Scale (HAMD) and/or Hamilton Anxiety Scale (HAMA) scores \> 7 * known intolerance or allergy to any of the study drugs, alcohol, tobacco, narcotic, or opioid dependence * patients on anticoagulants * known hepatic/renal dysfunction * serious cardiac/cerebrovascular comorbidities * HbA1c≥7 * patients who were already on duloxetine or other SNRIs, monoamine oxidase inhibitors, tricyclic antidepressants, triptans, lithium, other antiepileptics, or buspirone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| resting Visual Analogue Score for pain | from enrolment to 3 months after surgery | The patient has to mark the degree of pain on a scale of 0 to 10 with 10 being the worst pain ever felt and 0 being no pain value were minimum 0 to maximum 10 Higher number denotes more pain and worse outcome |
| Visual Analogue Score for pain on movement | from enrolment to 3 months after surgery | The patient has to mark the degree of pain on a scale of 0 to 10 with 10 being the worst pain ever felt and 0 being no pain value were minimum 0 to maximum 10 Higher number denotes more pain and worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NSAID consumption | from enrolment to 3 months after surgery | calculated in milligrams of etoricoxib with higher number denoting worse outcome |
| adverse effects | from enrolment to 3 months after surgery | — |
Countries
India
Outcome results
None listed