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| Name | Class |
|---|---|
| The Grant Medical College & Sir J.J. Group of Hospitals | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine group | Active Comparator | Patients given duloxetine |
|
| Placebo group | Placebo Comparator | Patients given starch capsules identical in appearance and weight to the duloxetine capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine - low dose | Drug | Only patients who underwent single bilateral Total knee arthroplasty and WITHOUT central sensitisation were evaluated |
|
| Measure | Description | Time Frame |
|---|---|---|
| resting Visual Analogue Score for pain | 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 | from enrolment to 3 months after surgery |
| Visual Analogue Score for pain on movement | 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 | from enrolment to 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| NSAID consumption | calculated in milligrams of etoricoxib with higher number denoting worse outcome | from enrolment to 3 months after surgery |
| adverse effects | from enrolment to 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Arthroscopy Knee and shoulder clinic | Mumbai | Maharasthra | 400007 | India |
Can be made available upon reasonable request
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| Placebo | Drug | starch capsules identical in appearance and weight to the duloxetine capsules |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 23, 2025 | Sep 9, 2025 | 1 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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