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The use of closed aspirative surgical drainage presents a truly questionable role in the field of orthopedic surgery.
The pathophysiological mechanisms on which it acts have been widely theorized, as well as the disadvantages that could be associated, both at a biological and socio-sanitary level, so that clinical guidelines opt to leave the decision to the surgeon's discretion.
Although its application and postoperative complications in knee arthroplasty are widely documented, the results are inconclusive and the scientific community does not seem to reach a consensus.
The main debate centers on bleeding during the immediate postoperative period, a classic complication of these interventions, but which seems to be being avoided with the introduction of new techniques and drugs, mainly the use of tranexamic acid.
However, a fundamental element of the postoperative period of these interventions that all the research seems to omit is pain in the postoperative period, which is key, as the pain of gonarthrosis is the main indication for the intervention.
It is because of this lack in the essential knowledge of this intervention that we propose the following hypothesis: the use of drainage in knee arthroplasty does not reduce pain during the early postoperative period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRAINAGE GROUP (A) | Experimental | Patients in group A will have a Redon drain placed at the end of the procedure. Both groups of patients will be explained early active flexion-extension exercises to initiate mobilization and multimodal analgesia will be provided. Patients in group A will receive perioperative care adapted to the drainage. All patients will have their baseline pain measured preoperatively and postoperatively using an analog rating scale. Patients will be checked if they require morphine rescue analgesia during their hospital stay. Postoperative pain assessment will be performed at discharge. |
|
| NO DRAINAGE GROUP (B) | No Intervention | Patients in group B will not have a Redon drain placed at the end of the procedure. Both groups of patients will be explained early active flexion-extension exercises to initiate mobilization and multimodal analgesia will be provided. All patients will have their baseline pain measured preoperatively and postoperatively using an analog rating scale. Patients will be checked if they require morphine rescue analgesia during their hospital stay. Postoperative pain assessment will be performed at discharge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Redon drain | Procedure | Patients in group A will have a Redon drain placed at the end of the procedure following the usual technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative baseline pain and postoperative pain at discharge | Preoperative baseline pain and postoperative pain at discharge, both assessed using an Analog Rating Scale (scale 0-10) | Preoperative baseline pain (Day 0) and postoperative pain at discharge (Day 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Weight in kilograms (kg) divided by the square of height in meters (m2) | BMI measured in Day 0 (at the time of admision in hospital) |
| Measure | Description | Time Frame |
|---|---|---|
| Use of opioid rescue during hospital stay | Total opioid rescue doses administered throughout the entire period of hospitalization following surgery until medical discharge | Measured the day of medical discharge, on average postoperative day 2 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Unievrsitario Reina Sofia de Córdoba | Córdoba | CORDOBA | 14004 | Spain |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Comparative prospective clinical trial between 2 groups of randomly selected patients (30 patients each)
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |