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Completed

NCT Number: NCT06837012

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine - low dose

Drug

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

Placebo

Drug

starch capsules identical in appearance and weight to the duloxetine capsules

Primary outcomes

  1. resting Visual Analogue Score for pain

    Time frame: 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

  2. Visual Analogue Score for pain on movement

    Time frame: 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 outcomes

  1. NSAID consumption

    Time frame: from enrolment to 3 months after surgery

    calculated in milligrams of etoricoxib with higher number denoting worse outcome

  2. adverse effects

    Time frame: from enrolment to 3 months after surgery

Sponsors and collaborators

Lead sponsor

Orthopaedic Arthroscopy Knee and Shoulder Clinic

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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