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In an estimated 150,000 patients, a knee joint replacement is performed in Germany every year. The perioperative care of the patients aims at an optimal surgical technique, which leads to a high functionality in the joint, and above all at an adequate pain treatment. Patients experience pain especially intraoperatively and in the first days after the operation. The intensity of pain is a decisive factor that can hinder the patient's mobilization. In the KneeOptOut study (ethics application number EA4/009/17), which has already been successfully carried out and approved by this ethics committee, it was shown that the use of local infiltration anaesthesia (LIA) for pain therapy after primary knee endoprosthetics is comparable to catheter-supported regional anaesthesia (manuscript under review at the European Journal of Anaesthesiology). During surgery, the morphine requirement of patients in the LIA group was significantly higher than that of patients who underwent catheterization. Postoperatively, however, both subjective pain by VAS and opiate consumption were comparable.
In order to optimize the intraoperative opiate need/consumption, an early-intraoperative procedure for local infiltration anesthesia will now be compared with the previous late-intraoperative procedure. Both procedures correspond to SOP for the treatment of primary knee endoprostheses and are currently used depending on the surgeon's requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-intraoperative Local infiltration technique | Experimental | A distal regional anaesthesia is performed in which the nerves are blocked by a local anaesthetic in the tissue in the immediate vicinity of the operating area ("tissue infiltration technique"). The LIA is applied in a total of 4 steps during the preparation of the knee joint: 1. after the skin incision, 2. after the capsule incision, 3. after complete exposure of the knee joint, 4. when the posterior knee capsule is reached. |
|
| Late-intraoperative Local infiltration technique | Active Comparator | A distal regional anaesthesia is performed in which the nerves are blocked by a local anaesthetic in the tissue in the immediate vicinity of the operating area ("tissue infiltration technique"). The LIA is applied after the preparation of the femur and tibia bone shortly before the prosthesis is inserted and during the retreat from the knee joint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Late local infiltration analgesia | Procedure | Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | amount of opioids administered intraoperative measured as equivalent dose to morphin | intraoperative, up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| time to first mobilisation (standing) | time from end of surgery until patients is able to stand | up to 48 hours postoperatively |
| patients satisfaction (11-point likert scale) | global satisfaction of patients |
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Inclusion Criteria:
• patients undergoing elective, primary knee joint replacement in combined general anaesthesia
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21312140 | Background | Morin AM, Wulf H. [High volume local infiltration analgesia (LIA) for total hip and knee arthroplasty: a brief review of the current status]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2011 Feb;46(2):84-6. doi: 10.1055/s-0031-1272875. Epub 2011 Feb 10. German. | |
| 26227482 | Background | Perret M, Fletcher P, Firth L, Yates P. Comparison of patient outcomes in periarticular and intraarticular local anaesthetic infiltration techniques in total knee arthroplasty. J Orthop Surg Res. 2015 Jul 31;10:119. doi: 10.1186/s13018-015-0249-x. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Investigator and treating physicians are different in this trial, that means, the assessor of primary study endpoint will be blinded regarding group allocation. Patients receive either early or late local infiltration technique perioperatively. Patients will be blinded against early or late local infiltration technique. Blinding of the treating physician will not be possible.
|
| Early local infiltration analgesia | Procedure | The local infiltration analgesia is applied in a total of 4 steps during the preparation of the knee joint: 1. after the skin incision, 2. after the capsule incision, 3. after complete exposure of the knee joint, 4. when the posterior knee capsule is reached. |
|
|
| up to 7 days postoperatively |
| time to first mobilisation (walking) | time from end of surgery until patients is able to walk | up to 7 days postoperatively |
| time to achieve full joint mobility | time to achieve full joint mobility (0/0/90°) | up to 7 days postoperatively |
| Janda grade of both legs at first day after surgery | best Janda grade in both legs the day after surgery | up to 24h postoperatively |
| Pain intensity | intensity of pain in all patients meausered by numeric rating scale (NRS) | up to 7 days postoperatively |
| rescue pain medication | number of patients requiring rescue pain medication | up to 7 days postoperatively |
| time to discharge | time to discharge from hospital | up to 14 days postoperatively |
| Opioid consumption (hospital) | amount of opioids administered until discharge measured as equivalent dose to morphin | up to 14 days postoperatively |
| delirium | incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc) | up to 7 days postoperatively |
| postoperative nausea and vomiting (PONV) | incidence of PONV | up to 7 days postoperatively |
| surgeon satisfaction (6-point likert scale) | satisfaction of surgeon in points of clarity of the operative field, change of the operative field by LIA and overall satisfaction represented in one value | intraoperative, up to 3 hours |
| 16950075 | Background | Peters CL, Shirley B, Erickson J. The effect of a new multimodal perioperative anesthetic regimen on postoperative pain, side effects, rehabilitation, and length of hospital stay after total joint arthroplasty. J Arthroplasty. 2006 Sep;21(6 Suppl 2):132-8. doi: 10.1016/j.arth.2006.04.017. |
| 26321550 | Background | Suthersan M, Pit S, Gordon L, Loman M, Pezzutti B, Freihaut R. Local infiltration analgesia versus standard analgesia in total knee arthroplasty. J Orthop Surg (Hong Kong). 2015 Aug;23(2):198-201. doi: 10.1177/230949901502300217. |
| 30562225 | Background | Kastelik J, Fuchs M, Kramer M, Trauzeddel RF, Ertmer M, von Roth P, Perka C, Kirschbaum SM, Tafelski S, Treskatsch S. Local infiltration anaesthesia versus sciatic nerve and adductor canal block for fast-track knee arthroplasty: A randomised controlled clinical trial. Eur J Anaesthesiol. 2019 Apr;36(4):255-263. doi: 10.1097/EJA.0000000000000929. |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |