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

University of Indonesia (UI)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Analgesia

Treatments: Drug: Paracetamol injection and normal saline; Drug: Ibuprofen Injection and normal saline; Drug: Paracetamol injection and Ibuprofen injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04414995

Pct-Ibf-FKUI

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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36 participants in 3 patient groups

Paracetamol+Ibuprofen

Experimental group

Description:

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.

Treatment:

Drug: Paracetamol injection and Ibuprofen injection

Paracetamol+normal saline

Experimental group

Description:

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.

Treatment:

Drug: Paracetamol injection and normal saline

Ibuprofen+normal saline

Experimental group

Description:

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.

Treatment:

Drug: Ibuprofen Injection and normal saline