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

NCT ID: NCT06837012

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-07-31

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.

Conditions

Osteoarthritis of Knee; Central Sensitization; Central Sensitisation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Duloxetine group

Patients given duloxetine

Group Type: ACTIVE_COMPARATOR

Duloxetine - low dose

Intervention Type: DRUG

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

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

starch capsules identical in appearance and weight to the duloxetine capsules

Interventions

Duloxetine - low dose

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

Intervention Type: DRUG

Placebo

starch capsules identical in appearance and weight to the duloxetine capsules

Intervention Type: DRUG

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Grant Medical College & Sir J.J. Group of Hospitals

OTHER_GOV

Sponsor Role: collaborator

Orthopaedic Arthroscopy Knee and Shoulder Clinic

OTHER

Sponsor Role: lead

Responsible Party

Dr. Amyn Rajani

Consultant Orthopaedic surgeon, Department of Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Orthopaedic Arthroscopy Knee and shoulder clinic

Mumbai, Maharasthra, India

Countries

India

Other Identifiers

MDC/12/12/2020

Identifier Type: -

Identifier Source: org_study_id