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Optimization of a Fast-track Concept for Knee Joint Replacement (KneeOptOut2)

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ClinicalTrials.gov Identifier: NCT03920930
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sascha Treskatsch, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
Opioid consumption [ Time Frame: intraoperative, up to 3 hours ]
amount of opioids administered intraoperative measured as equivalent dose to morphin
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
  • time to first mobilisation (standing) [ Time Frame: up to 48 hours 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
  • time to achieve full joint mobility [ Time Frame: up to 7 days postoperatively ]
    time to achieve full joint mobility (0/0/90°)
  • Janda grade of both legs at first day after surgery [ Time Frame: up to 24h postoperatively ]
    best Janda grade in both legs the day after surgery
  • Pain intensity [ Time Frame: up to 7 days postoperatively ]
    intensity of pain in all patients meausered by numeric rating scale (NRS)
  • rescue pain medication [ Time Frame: up to 7 days postoperatively ]
    number of patients requiring rescue pain medication
  • time to discharge [ Time Frame: up to 14 days postoperatively ]
    time to discharge from hospital
  • Opioid consumption (hospital) [ Time Frame: up to 14 days postoperatively ]
    amount of opioids administered until discharge measured as equivalent dose to morphin
  • delirium [ Time Frame: up to 7 days postoperatively ]
    incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc)
  • postoperative nausea and vomiting (PONV) [ Time Frame: up to 7 days postoperatively ]
    incidence of PONV
  • surgeon satisfaction (6-point likert scale) [ Time Frame: intraoperative, up to 3 hours ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • 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
  • time to achieve full joint mobility [ Time Frame: up to 7 days postoperatively ]
    time to achieve full joint mobility (0/0/90°)
  • Janda grade of both legs at first day after surgery [ Time Frame: up to 24h postoperatively ]
    best Janda grade in both legs the day after surgery
  • Pain intensity [ Time Frame: up to 7 days postoperatively ]
    intensity of pain in all patients meausered by numeric rating scale (NRS)
  • rescue pain medication [ Time Frame: up to 7 days postoperatively ]
    number of patients requiring rescue pain medication
  • time to discharge [ Time Frame: up to 14 days postoperatively ]
    time to discharge from hospital
  • Opioid consumption (hospital) [ Time Frame: up to 14 days postoperatively ]
    amount of opioids administered until discharge measured as equivalent dose to morphin
  • delirium [ Time Frame: up to 7 days postoperatively ]
    incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc)
  • postoperative nausea and vomiting (PONV) [ Time Frame: up to 7 days postoperatively ]
    incidence of PONV
  • surgeon satisfaction (6-point likert scale) [ Time Frame: intraoperative, up to 3 hours ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimization of a Fast-track Concept for Knee Joint Replacement
Official Title  ICMJE Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 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.
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Arthropathy
  • Postoperative Pain
  • Postoperative Complications
Intervention  ICMJE
  • Procedure: Late local infiltration analgesia
    Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
    Other Name: late LIA
  • Procedure: Early local infiltration analgesia
    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.
    Other Name: early LIA
Study Arms  ICMJE
  • Experimental: Early-intraoperative Local infiltration technique
    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.
    Intervention: Procedure: Early local infiltration analgesia
  • Active Comparator: Late-intraoperative Local infiltration technique
    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.
    Intervention: Procedure: Late local infiltration analgesia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sascha Treskatsch, MD, Prof 004930450631011 sascha.treskatsch@charite.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920930
Other Study ID Numbers  ICMJE KneeOptOut2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sascha Treskatsch, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Charite University, Berlin, Germany
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP