Duloxetine As an Analgesic in Patients Without Central Sensitivity After Same Sitting Bilateral Total Knee Arthroplasty

Orthopaedic Arthroscopy Knee and Shoulder Clinic106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

106

Conditions

Osteoarthritis of Knee Central Sensitization Central Sensitisation

Interventions

Duloxetine - low doseDRUG

Only patients who underwent single bilateral Total knee arthroplasty and WITHOUT central sensitisation were evaluated

PlaceboDRUG

starch capsules identical in appearance and weight to the duloxetine capsules

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Orthopaedic Arthroscopy Knee and shoulder clinic

Mumbai, Maharasthra, India

Outcomes

Primary Outcomes

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

Time frame: from enrolment to 3 months after surgery

Visual Analogue Score for pain on movement

Time frame: from enrolment to 3 months after surgery

Secondary Outcomes

NSAID consumption

calculated in milligrams of etoricoxib with higher number denoting worse outcome

Time frame: from enrolment to 3 months after surgery

adverse effects

Time frame: from enrolment to 3 months after surgery

Data from ClinicalTrials.gov

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