Evaluation of a Fast-track Knee Arthroplasty Concept (KneeOptOut)
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|ClinicalTrials.gov Identifier: NCT03114306|
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Arthropathy Postoperative Pain Postoperative Complications||Procedure: local infiltration analgesia Procedure: regional-anaesthesiological catheter analgesia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Implementation of a Fast-track Knee Arthroplasty Concept: a Randomized, Controlled, Open Clinical Trial|
|Actual Study Start Date :||April 5, 2017|
|Actual Primary Completion Date :||August 30, 2017|
|Actual Study Completion Date :||August 30, 2017|
Experimental: local infiltration analgesia
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.
Procedure: local infiltration analgesia
Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
Other Name: LIA technique
Active Comparator: Regional anaesthesia
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).
Procedure: regional-anaesthesiological catheter analgesia
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.
- time to first mobilisation (standing) [ Time Frame: up to 48h postoperatively ]time from end of surgery until patients is able to stand
- patients satisfaction (11-point likert scale) [ Time Frame: up to 7 days postoperatively ]global satisfaction of patients
- time to first mobilisation (walking) [ Time Frame: up to 7 days postoperatively ]time from end of surgery until patients is able to walk
- complications [ Time Frame: up to 7 days postoperatively ]complications during perioperative care process (e.g. thrombosis, re-operation, infection)
- time to achieve full joint mobility [ Time Frame: up to 7 days postoperatively ]time to achieve full joint mobility (0/0/90°)
- pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean) [ Time Frame: up to 7 days postoperatively ]mean pain intensity of patients
- rescue pain medication [ Time Frame: up to 7 days postoperatively ]number of patients requiring rescue pain medication
- pain medication perioperatively [ Time Frame: up to 7 days postoperatively ]pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics)
- time to discharge [ Time Frame: up to 14 days postoperatively ]time to discharge from hospital
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114306
|Charité University Berlin (CCM)|
|Berlin, Germany, 13353|
|Principal Investigator:||Sascha Treskatsch, Prof.||Charite University Berlin, Department of anaesthesia|