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

Phase 4

Completed

• Conditions: Osteoarthritis of Knee; Central Sensitization; Central Sensitisation
• Interventions: Drug: Duloxetine - low dose; Drug: Placebo

• Registration Number: NCT06837012
• Lead Sponsor: Orthopaedic Arthroscopy Knee and Shoulder Clinic

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duloxetine group	Duloxetine - low dose	Patients given duloxetine
Placebo group	Placebo	Patients given starch capsules identical in appearance and weight to the duloxetine capsules

Primary Outcome Measures

Name	Time	Method
resting Visual Analogue Score for pain	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
Visual Analogue Score for pain on movement	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

Secondary Outcome Measures

Name	Time	Method
NSAID consumption	from enrolment to 3 months after surgery	calculated in milligrams of etoricoxib with higher number denoting worse outcome
adverse effects	from enrolment to 3 months after surgery

Trial Locations

Locations (1)

Orthopaedic Arthroscopy Knee and shoulder clinic; 🇮🇳 Mumbai, Maharasthra, India