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

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.

Study Overview

• Status: Completed
• Conditions: Central Sensitization; Osteoarthritis of Knee; Central Sensitisation
• Intervention / Treatment: Drug: Duloxetine - low dose; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Maharasthra
    • Mumbai, Maharasthra, India, 400007
      • Orthopaedic Arthroscopy Knee and shoulder clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Duloxetine group; Patients given duloxetine	Drug: Duloxetine - low dose; Only patients who underwent single bilateral Total knee arthroplasty and WITHOUT central sensitisation were evaluated
Placebo Comparator: Placebo group; Patients given starch capsules identical in appearance and weight to the duloxetine capsules	Drug: Placebo; starch capsules identical in appearance and weight to the duloxetine capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NSAID consumption	calculated in milligrams of etoricoxib with higher number denoting worse outcome	from enrolment to 3 months after surgery
adverse effects		from enrolment to 3 months after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Total knee arthroplasty; Duloxetine; Chronic; Analgesic; SNRI; Central sensitisation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Serotonin and Noradrenaline Reuptake Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Sensory System Agents; Analgesics; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Antidepressive Agents; Duloxetine Hydrochloride
• Other Study ID Numbers: MDC/12/12/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Can be made available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes