Clinical trial NCT06837012: Duloxetine As an Analgesic in Patients Without Central Sensitivity After Same Sitting Bilateral Total Knee Arthroplasty
Official title: Duloxetine As an Analgesic in Patients Without Central Sensitivity Undergoing Single-sitting, Bilateral Total Knee Arthroplasty: a Prospective, Double-blinded, Randomised, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of Knee
Central Sensitization
Central Sensitisation
Keywords: Duloxetine
Total knee arthroplasty
Analgesic
Central sensitisation
Pain
SNRI
Chronic
Lead sponsor: Orthopaedic Arthroscopy Knee and Shoulder Clinic
Sponsor class: OTHER
Collaborators: name: The Grant Medical College & Sir J.J. Group of Hospitals
First posted: 2025-02-20
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: resting Visual Analogue Score for pain
timeFrame: from enrolment to 3 months after surgery
measure: Visual Analogue Score for pain on movement
timeFrame: from enrolment to 3 months after surgery
Secondary outcomes:
measure: NSAID consumption
timeFrame: from enrolment to 3 months after surgery
measure: adverse effects
timeFrame: from enrolment to 3 months after surgery
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Orthopaedic Arthroscopy Knee and shoulder clinic
state: Maharasthra
Study officials:
References: