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

December 20, 2020 updated by: Andri Maruli Tua Lubis, Indonesia University

Effect of Paracetamol and Ibuprofen When Intravenously Given Combination or Alone in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 12430
        • Fatmawati General Hospital
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo National General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Paracetamol+Ibuprofen
Patients in Group 1 will receive a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation following by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours.
Drug: Paracetamol injection and Ibuprofen injection
Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty
Other Names:
  • Paracetamol and Ibuprofen
EXPERIMENTAL: Paracetamol+normal saline
Patients in Group 2 will receive 1000 mg IV paracetamol and 100 ml IV normal salines at the end of operation following by 1000 mg IV paracetamol and 100 ml IV normal salines every 6 hours up to 72 hours.
Drug: Paracetamol injection and normal saline
Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
Other Names:
  • Paracetamol injection
EXPERIMENTAL: Ibuprofen+normal saline
Patients in Group 3 will receive 800 mg IV ibuprofen and 100 ml IV normal salines at the end of operation following by 800 mg IV ibuprofen and 100 ml IV normal salines every 6 hours up to 72 hours.
Drug: Ibuprofen Injection and normal saline
Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
Other Names:
  • Ibuprofen injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine requirement
Time Frame: 24 hours
morphine requirement in patient after total knee arthroplasty procedure
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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")
24 hours, 48 hours, 72 hours
range of motion knee in flexion and extension
Time Frame: 24 hours, 48 hours, 72 hours
range of motion knee in flexion and extension
24 hours, 48 hours, 72 hours
2MWT after total knee arthroplasty procedure
Time Frame: 24 hours, 48 hours, 72 hours
amount of walking length in 2 minutes
24 hours, 48 hours, 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Andri MT Lubis, MD, PhD, Fakultas Kedokteran Universitas Indonesia
  • Principal Investigator: Aida R Tantri, MD, Fakultas Kedokteran Universitas Indonesia
  • Principal Investigator: Ludwig AP Pontoh, MD, Fakultas Kedokteran Universitas Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 5, 2020

Primary Completion (ACTUAL)

November 30, 2020

Study Completion (ACTUAL)

December 15, 2020

Study Registration Dates

First Submitted

May 31, 2020

First Submitted That Met QC Criteria

May 31, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 20, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pct-Ibf-FKUI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol, Statistical Analysis Plan (SAP)

IPD Sharing Time Frame

data will become available after study completion.

IPD Sharing Access Criteria

others researches contact

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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