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The study compares three different analgesic techniques in order to determine which one serves as the optimal method for postoperative pain management after Total Knee Arthroplasty in patients suffering from Osteoarthritis
Prospective, randomized, controlled study. Approval of the study from the University Hospital of Patras Ethics Committee. The Total Knee Arthroplasty procedure is performed always from the same team of Orthopedic surgeons who follow the same technique in each patient for the arthroplasty and the placement of the intraarticular catheter as well. The same team of Anesthesiologists (two Anesthesiologists) performs always the same technique for each analgesic method and is responsible for the patients' perioperative condition concerning anesthesia and analgesia.
Preoperatively, one hour prior to the surgery, all patients receive preemptive multimodal analgesia in the following way; 40mg Parecoxib (iv), 1gr Paracetamol (iv), 150mg Pregabalin (po), 8mg Dexamethasone (iv) και 50mg Ranitidine (iv).
All patients receive subarachnoid anesthesia with Ropivacaine 0.75% (7,5mg/ml) in a dosage of 2-3ml titrated according to patient's age and height.
Three groups
All the catheters remain for 48 hours while the infusion rate is 2ml/h + PCA with 0,5ml/15min and lock-out maximum dose 4/h in total volume of 150ml.
Postoperatively all patients also receive; Parecoxib, Paracetamol, Pregabalin, and Ranitidine up to the third postoperative day (doses titrated).
Rescue analgesia: Tramadol Chloride 50-100mg x 2 /24h depending on patient's age and medical history.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group E- Epidural analgesia | Active Comparator | Continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure. The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The epidural catheter is placed preoperatively. |
|
| Group F- Femoral blockade | Active Comparator | Continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure.The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The femoral catheter is placed preoperatively. |
|
| Group I- Intraarticular infusion | Active Comparator | Continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure.The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The intraarticular catheter is placed before the closure of the incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural analgesia - Group E | Procedure | Postoperative analgesia with continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesia | Pain scores, during rest and movement (active and passive) according to NRS (Numeric Rating Scale) right after the end of the surgery and 2, 4, 6, 12, 24, 36, 48, 60 and 72 hours later (postoperatively) | Up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mobilization | Time of mobilization (standing, walking in room, walking out of room) | Up to 3 days |
| LOS | Length of hospital stay | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fotini Fligou, MD, PhD | University of Patras, Department of Anesthesiology and Critical Care Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Patras | Pátrai | Achaia | 26500 | Greece |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 23, 2022 | |
| Reset | Sep 29, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 23, 2022 | Sep 29, 2023 |
| 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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| Femoral blockade - Group F | Procedure | Postoperative analgesia with continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min) . |
|
| Intraarticular infusion - Group I | Procedure | Postoperative analgesia with continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min) |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |