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

Orthopaedic Arthroscopy Knee and Shoulder Clinic

Status and phase

Completed

Phase 4

Conditions

Central Sensitization

Osteoarthritis of Knee

Central Sensitisation

Treatments

Drug: Duloxetine - low dose

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06837012

MDC/12/12/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.