Osteoarthritis
Conditions
Keywords
tourniquet pressure, total knee arthroplasty
Brief summary
This study aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet inflation.
Detailed description
We will compare the two groups of patients undergoing total knee arthroplasty, which the tourniquet pressure will be set differently: systolic blood pressure plus 120mmHg vs. systolic blood pressure plus 150mmHg, the conventional method, in terms of efficacy and safety.
Interventions
PROCEDURELow tourniquet pressure
Tourniquet pressure set as 120mmHg above the systolic blood pressure just before tourniquet inflation
PROCEDUREConventional tourniquet pressure
Tourniquet pressure set as 150mmHg above the systolic blood pressure just before tourniquet inflation
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* The patients undergoing total knee arthroplasty
Exclusion criteria
* Systolic blood pressure measured at ward \> 200mmHg * Thigh circumference \> 78cm * Anesthesia other than spinal anesthesia * Simultaneous bilateral total knee arthroplasty * The patients who disagreed the enrollment of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acquisition of bloodless surgical field just after skin incision | just after skin incision during operation | Dichotomous variable determined during operation by operator (Yes or No) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increasement of tourniquet pressure to acquire bloodless surgical field | after skin incision though the point of tourniquet deflation | We will increase the tourniquet pressure by 30mmHg from the initial tourniquet pressure, if we will fail to achieve bloodless surgical field during operation. The increasement of tourniquet pressure will be recorded if it will be needed during operation. |
| Thigh pain on the site of tourniquet application | postoperative 2nd day | measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale |
| Knee pain | postoperative 2nd day | measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale |
| Failure of acquiring bloodless surgical field during operation | after skin incision through the point of tourniquet deflation | — |
| Nerve palsy | within 7 days after surgery | — |
| symptomatic venous-thromboembolism | within 7 days after surgery | It includes deep vein thrombosis and pulmonary embolism which are symptomatic and diagnosed by confirmative test, such as CT angiogram. |
| Skin problem on the site of tourniquet application | posteoperative 2nd day | It includes ecchymosis, bullae formation and skin necrosis. |
Countries
South Korea
Contacts
Primary ContactT K Kim, MD, PhD
Outcome results
None listed