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Mobilisation following knee arthroplasty is an important aspect to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. This RCT evaluates two analgetic regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.
Mobilisation following knee arthroplasty is important for patients to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. There is evidence that regional- anaesthesiological catheter techniques are very efficient to control pain postoperatively. On the other hand, motoric function may be reduced due to nerve blocks depending on location and concentration of drug used. Local infiltration of the knee during surgery is an alternative component in pain management that may reduce impaired motor function and allow early mobilisation of patients. However, currently it is not known which analgesia technique provides optimal pain control paralleled with sufficient motor function. Against this background, this RCT evaluates two analgesia regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local infiltration analgesia | Experimental | Patient receive an infiltration of local anaesthetics around the knee to achieve maximal distal block of nerve fibres. Infiltration is performed directly after knee replacement and during weaning of general anaesthesia. |
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| Regional anaesthesia | Active Comparator | Patients receive a combined anaesthesia with a regional-anaesthesiological catheter placed close to the distal Nervus saphenus and a single shot anaesthesia of Nervus ischiadicus using local anaesthetics (regional-anaesthesiological catheter analgesia). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|---|---|---|
| time to first mobilisation (standing) | time from end of surgery until patients is able to stand | up to 48h postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| patients satisfaction (11-point likert scale) | global satisfaction of patients | up to 7 days postoperatively |
| time to first mobilisation (walking) | time from end of surgery until patients is able to walk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sascha Treskatsch, Prof. | Charite University Berlin, Department of anaesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité University Berlin (CCM) | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17464601 | Background | Rostlund T, Kehlet H. High-dose local infiltration analgesia after hip and knee replacement--what is it, why does it work, and what are the future challenges? Acta Orthop. 2007 Apr;78(2):159-61. doi: 10.1080/17453670710013627. No abstract available. | |
| 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. |
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Individual requests to analyse data are to be evaluated by local data safety authorities
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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 regional-anaesthesiological catheters preoperatively or are treatet with local infiltration technique perioperatively. For the purpose of this trial is would not be feasable to perform sham regional-anaesthesiological procedures and blinding of the treating physisican will not be possible.
|
| regional-anaesthesiological catheter analgesia | Procedure | Patients receive a single shot nerve block of the proximal Nervus ischiadicus and a catheter placed closed to the Nervus saphenus for perioperative pain control using ultrasound guided techniques. |
|
| up to 7 days postoperatively |
| complications | complications during perioperative care process (e.g. thrombosis, re-operation, infection) | 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 |
| pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean) | mean pain intensity of patients | up to 7 days postoperatively |
| rescue pain medication | number of patients requiring rescue pain medication | up to 7 days postoperatively |
| pain medication perioperatively | pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics) | up to 7 days postoperatively |
| time to discharge | time to discharge from hospital | up to 14 days postoperatively |
| 30562225 | Result | 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. |
| 35337268 | Result | Borck M, Wandrey JD, Hoft M, Kastelik J, Perka C, Tafelski S, Treskatsch S. Local infiltration analgesia versus peripheral nerve block anaesthesia in total knee arthroplasty: a pharmaco-economic comparison. BMC Anesthesiol. 2022 Mar 25;22(1):80. doi: 10.1186/s12871-022-01620-w. |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |