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Evaluation of a Fast-track Knee Arthroplasty Concept (KneeOptOut)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114306
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Sascha Treskatsch, Charite University, Berlin, Germany

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Arthropathy Postoperative Pain Postoperative Complications Procedure: local infiltration analgesia Procedure: regional-anaesthesiological catheter analgesia Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. time to first mobilisation (standing) [ Time Frame: up to 48h postoperatively ]
    time from end of surgery until patients is able to stand


Secondary Outcome Measures :
  1. patients satisfaction (11-point likert scale) [ Time Frame: up to 7 days postoperatively ]
    global satisfaction of patients

  2. time to first mobilisation (walking) [ Time Frame: up to 7 days postoperatively ]
    time from end of surgery until patients is able to walk

  3. complications [ Time Frame: up to 7 days postoperatively ]
    complications during perioperative care process (e.g. thrombosis, re-operation, infection)

  4. time to achieve full joint mobility [ Time Frame: up to 7 days postoperatively ]
    time to achieve full joint mobility (0/0/90°)

  5. 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

  6. rescue pain medication [ Time Frame: up to 7 days postoperatively ]
    number of patients requiring rescue pain medication

  7. pain medication perioperatively [ Time Frame: up to 7 days postoperatively ]
    pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics)

  8. time to discharge [ Time Frame: up to 14 days postoperatively ]
    time to discharge from hospital



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing elective, primary knee joint replacement in combined general anaesthesia

Exclusion Criteria:

  • heart insufficiency NYHA >2
  • liver insufficiency > CHILD B
  • evidence of diabetic polyneuropathy
  • severe adipositas BMI >40
  • patients < 18 years
  • pregnancy
  • in case of police custody
  • participation in a paralleled interventional RCT in a time frame of 30 days
  • chronic opioid therapy >3 months before scheduled surgery
  • allergy against medication required for surgery or anaesthesia

Information from the National Library of Medicine

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


Locations
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Germany
Charité University Berlin (CCM)
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Sascha Treskatsch, Prof. Charite University Berlin, Department of anaesthesia
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sascha Treskatsch, Head of department, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03114306    
Other Study ID Numbers: KneeOptOut
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual requests to analyse data are to be evaluated by local data safety authorities

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sascha Treskatsch, Charite University, Berlin, Germany:
ERAS
pain
knee arthroplasty
joint pain
regional anaesthesia
Additional relevant MeSH terms:
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Joint Diseases
Postoperative Complications
Pathologic Processes
Musculoskeletal Diseases