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

NCT06837012 | Completed Phase 4 FDA Drug

• 1 other identifier: MDC/12/12/2020
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of Knee; Central Sensitization; Central Sensitisation

Keywords

Duloxetine; Total knee arthroplasty; Analgesic; Central sensitisation; Pain; SNRI; Chronic

Outcome Measures

Primary Outcomes (2)

• 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

  from enrolment to 3 months after surgery

• Visual Analogue Score for pain on movement

  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

  from enrolment to 3 months after surgery

Secondary Outcomes (2)

• NSAID consumption

  from enrolment to 3 months after surgery

• adverse effects

  from enrolment to 3 months after surgery

Study Arms (2)

Duloxetine group

ACTIVE COMPARATOR

Patients given duloxetine

Drug: Duloxetine - low dose

Placebo group

PLACEBO COMPARATOR

Patients given starch capsules identical in appearance and weight to the duloxetine capsules

Drug: Placebo

Interventions

Duloxetine - low dose DRUG

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

Duloxetine group

Placebo DRUG

starch capsules identical in appearance and weight to the duloxetine capsules

Placebo group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral tricompartmental knee osteoarthritis
• Underwent primary, bilateral TKA in single-sitting

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orthopaedic Arthroscopy Knee and Shoulder Clinic: lead
• The Grant Medical College & Sir J.J. Group of Hospitals: collaborator

Study Sites (1)

Orthopaedic Arthroscopy Knee and shoulder clinic

Mumbai, Maharasthra, 400007, India

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Bronchiolitis Obliterans Syndrome

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Orthopaedic surgeon, Department of Orthopaedics

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 20, 2025
• Study Start: January 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)