Clinical trial NCT04414995: Effect of Paracetamol and Ibuprofen Reducing Morphine Requirements After Total Knee Arthroplasty
Official title: Effect of Paracetamol and Ibuprofen When Intravenously Given Combination or Alone in Reducing Morphine Requirements After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Analgesia
Keywords: multi modal analgesia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients in Group 1 received a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation followed by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours.

Patients in Group 2 received 1000 mg IV paracetamol and 100 ml IV normal salines at the end of operation followed by 1000 mg IV paracetamol and 100 ml IV normal salines every 6 hours up to 72 hours.

Patients in Group 3 received 800 mg IV ibuprofen and 100 ml IV normal salines at the end of operation followed by 800 mg IV ibuprofen and 100 ml IV normal salines every 6 hours up to 72 hours.
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Total morphine requirement
timeFrame: 24 hours
Secondary outcomes:
measure: Numerical rating scale of pain in resting phase, walking phase, knee full flexion phase
timeFrame: 24 hours, 48 hours, 72 hours
measure: range of motion knee in flexion and extension
timeFrame: 24 hours, 48 hours, 72 hours
measure: 2MWT after total knee arthroplasty procedure
timeFrame: 24 hours, 48 hours, 72 hours
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo National General Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Fatmawati General Hospital
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Andri MT Lubis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Aida R Tantri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Ludwig AP Pontoh, MD
role: PRINCIPAL_INVESTIGATOR
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