Analgesia
Conditions
Keywords
multi modal analgesia
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
Interventions
DRUGParacetamol injection and Ibuprofen injection
Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty
DRUGParacetamol injection and normal saline
Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
DRUGIbuprofen Injection and normal saline
Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The study medication will be masked by the pharmacy. Participants, those administrating the intervention, other caregivers, outcome assessors, data managers, statisticians, and investigators drawing conclusions will be blinded to the intervention.
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine requirement | 24 hours | morphine requirement in patient after total knee arthroplasty procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Outcome results
None listed