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Completed

NCT Number: NCT04414995

Effect of Paracetamol and Ibuprofen Reducing Morphine Requirements After Total Knee Arthroplasty

Adequate pain management has an important role in supporting early ambulation after the Total Knee Arthroplasty (TKA). Multimodal analgesia is one of the modalities of overcoming postoperative pain. The use of combination Paracetamol and Ibuprofen injection is expected to reduce total morphine consumption after TKA.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fatmawati General Hospital, Jakarta, DKI Jakarta, Indonesia

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About this study

The research will compare the effect of paracetamol injection and ibuprofen injection when given alone or in combination to reduce morphine requirement in a patient after total knee arthroplasty

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patient with 20 < BMI < 30 kg/m2
  • Adult patient with knee varus alignment 10-20°

Exclusion criteria

  • Impaired cardiac, liver, and/or renal function.
  • History of substance abuse or chronic pain.
  • Patients are known to be hypersensitive to any of the components of IV ibuprofen or IV paracetamol.
  • Patients currently on anticoagulation medications.
  • Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board) and agree to abide by the study restrictions.

Treatment and study plan

Paracetamol injection and Ibuprofen injection

Drug

Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty

Other names: Paracetamol and Ibuprofen

Paracetamol injection and normal saline

Drug

Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty

Other names: Paracetamol injection

Ibuprofen Injection and normal saline

Drug

Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty

Other names: Ibuprofen injection

Primary outcomes

  1. Total morphine requirement

    Time frame: 24 hours

    morphine requirement in patient after total knee arthroplasty procedure

Secondary outcomes

  1. Numerical rating scale of pain in resting phase, walking phase, knee full flexion phase

    Time frame: 24 hours, 48 hours, 72 hours

    amount of pain measure by numerical rating scale. Patients rate their pain from 0 to 10, Zero represents "no pain," whereas 10 represents the opposite end of the pain continuum (e.g., "the most intense pain imaginable," "pain as intense as it could be," "maximum pain")

  2. range of motion knee in flexion and extension

    Time frame: 24 hours, 48 hours, 72 hours

    range of motion knee in flexion and extension

  3. 2MWT after total knee arthroplasty procedure

    Time frame: 24 hours, 48 hours, 72 hours

    amount of walking length in 2 minutes

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effect of Paracetamol and Ibuprofen When Intravenously Given Combination or Alone in Reducing Morphine Requirements After Total Knee Arthroplasty

Acronym: PctIbfFKUI

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Dec 22, 2020

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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