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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Paracetamol injection and Ibuprofen injection
* Drug: Paracetamol injection and normal saline
* Drug: Ibuprofen Injection and normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracetamol+Ibuprofen<br>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<br>* Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty<br>* Other names: Paracetamol and Ibuprofen;|
| Experimental: Paracetamol+normal saline<br>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<br>* Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty<br>* Other names: Paracetamol injection;|
| Experimental: Ibuprofen+normal saline<br>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<br>* Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty<br>* Other names: Ibuprofen injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine requirement | 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 | 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 | range of motion knee in flexion and extension | 24 hours, 48 hours, 72 hours | 
| 2MWT after total knee arthroplasty procedure | amount of walking length in 2 minutes | 24 hours, 48 hours, 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multi modal analgesia