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

Phase 2

Completed

• Conditions: Analgesia
• Interventions: Drug: Ibuprofen Injection and normal saline; Drug: Paracetamol injection and Ibuprofen injection; Drug: Paracetamol injection and normal saline

• Registration Number: NCT04414995
• Lead Sponsor: Indonesia University

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

Study Timeline

• Study First Submitted: 2020-05-31
• Study First Submitted QC: 2020-05-31
• Study First Posted: 2020-06-04
• Study Start: 2020-06-05
• Primary Completion: 2020-11-30
• Status Verified: 2020-12
• Study Completion: 2020-12-15
• Last Update Submitted: 2020-12-20
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Ibuprofen+normal saline	Ibuprofen Injection and 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.
Paracetamol+Ibuprofen	Paracetamol injection and Ibuprofen injection	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.
Paracetamol+normal saline	Paracetamol injection and 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.

Primary Outcome Measures

Name	Time	Method
Total morphine requirement	24 hours	morphine requirement in patient after total knee arthroplasty procedure

Secondary Outcome Measures

Name	Time	Method
Numerical rating scale of pain in resting phase, walking phase, knee full flexion phase	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")
range of motion knee in flexion and extension	24 hours, 48 hours, 72 hours	range of motion knee in flexion and extension
2MWT after total knee arthroplasty procedure	24 hours, 48 hours, 72 hours	amount of walking length in 2 minutes

Trial Locations

Locations (2)

Cipto Mangunkusumo National General Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

Fatmawati General Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia