Total Knee Arthroplasty, Tourniquets
Conditions
Brief summary
This is a randomized controlled trial designed to research the effects of different tourniquet applications on postoperative pain in patients undergoing total knee arthroplasty, and to guide early postoperative recovery.
Detailed description
Sixty participants undergoing unilateral TKA would be recruited in this study. On one side, the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later(after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. On the other side the tourniquet would be inflated immediately before incision and deflated at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes. The postoperative pain, limb swelling , the score of surgical field, blood pressure during the operation, blood loss, operating time, transfusion rate, deep vein thrombosis (DVT) incidence and clinical outcomes would be monitored for comparison.
Interventions
PROCEDUREControl
The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.
PROCEDUREReinflation after early deflation
the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later (after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. The total time of tourniquet inflation is controlled within 90 minutes.
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* American Society of anesthesiologists Grade 1-3 Patients * Undergoing unilateral total knee arthroplasty under general anesthesia * Should be treated with tourniquet
Exclusion criteria
* Tourniquet inflation time is less than 1h, greater than 1.5h * Abnormal coagulation function * BMI \< 20kg/m2 or \> 35kg/m2 * History of cerebral infarction * History of Peripheral vascular disease * Anemia (hemoglobin\<90g/L) * Systolic blood pressure (SBP) ≥ 170mmHg * Pregnant blood glucose \> 10mmol/L or HbA1c \> 8.5% of diabetic patients * History of chronic narcotic use * Participate in other clinical trials at the same time * Asked to withdraw from the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 48 hours post surgery | tested by Visual Analogue Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelin-1 | one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation | tested by ELISA |
| Nitric Oxide | one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation | tested by ELISA |
| The rate of postoperative limb swelling | 24 hours post surgery, 48 hours post surgery | test the perimeter of the surgary limb at four fingers under the inguen,then Calculate the rate by formula (postoperative perimeter-preoperative perimeter)/preoperative perimeter |
| Hemoglobin | one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation | blood gas analysis g/L |
| partial pressure of oxygen in artery | one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation | blood gas analysis mmHg |
| Lac | one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation | blood gas analysis mmol/L |
Countries
China
Contacts
Primary ContactGuanglei Wang, MD
Backup ContactPei Liu, Bachelor
Outcome results
None listed