Orthopaedic Arthroscopy Knee and shoulder clinic
Mumbai, Maharasthra, 400007, India
NCT Number: NCT06837012
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.
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Interventional
Phase 4
Mumbai, Maharasthra, 400007, India
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Only patients who underwent single bilateral Total knee arthroplasty and WITHOUT central sensitisation were evaluated
starch capsules identical in appearance and weight to the duloxetine capsules
Time frame: 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
Time frame: 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
Time frame: from enrolment to 3 months after surgery
calculated in milligrams of etoricoxib with higher number denoting worse outcome
Time frame: from enrolment to 3 months after surgery
Orthopaedic Arthroscopy Knee and Shoulder Clinic
Other
Duloxetine As an Analgesic in Patients Without Central Sensitivity Undergoing Single-sitting, Bilateral Total Knee Arthroplasty: a Prospective, Double-blinded, Randomised, Placebo-controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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