NCT06837012

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

Duloxetine As an Analgesic in Patients Without Central Sensitivity Undergoing Single-sitting, Bilateral Total Knee Arthroplasty: a Prospective, Double-blinded, Randomised, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Orthopaedic Arthroscopy Knee and Shoulder Clinic · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Osteoarthritis of Knee
• Central Sensitization
• Central Sensitisation

Interventions

Type	Name	Description
DRUG	Duloxetine - low dose	Only patients who underwent single bilateral Total knee arthroplasty and WITHOUT central sensitisation were evaluated
DRUG	Placebo	starch capsules identical in appearance and weight to the duloxetine capsules

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2025-02-20
• Last updated: 2025-02-20

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study