Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Knee Arthropathy Postoperative Pain Postoperative Complications Procedure: Late local infiltration analgesia Procedure: Early local infiltration analgesia Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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
Official Title: Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : July 30, 2020

Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: intraoperative, up to 3 hours ]
    amount of opioids administered intraoperative measured as equivalent dose to morphin


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

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

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

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

  5. 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

  6. Pain intensity [ Time Frame: up to 7 days postoperatively ]
    intensity of pain in all patients meausered by numeric rating scale (NRS)

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

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

  9. Opioid consumption (hospital) [ Time Frame: up to 14 days postoperatively ]
    amount of opioids administered until discharge measured as equivalent dose to morphin

  10. delirium [ Time Frame: up to 7 days postoperatively ]
    incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc)

  11. postoperative nausea and vomiting (PONV) [ Time Frame: up to 7 days postoperatively ]
    incidence of PONV

  12. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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): NCT03920930


Contacts
Layout table for location contacts
Contact: Sascha Treskatsch, MD, Prof 004930450631011 sascha.treskatsch@charite.de

Locations
Layout table for location information
Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Sascha Treskatsch, MD, Prof    004930450631 ext 011    sascha.treskatsch@charite.de   
Sub-Investigator: Martin Ertmer, MD         
Sub-Investigator: Ralf F Trauzeddel, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Publications:
Layout table for additonal information
Responsible Party: Sascha Treskatsch, Prof. Dr. med., Head of Department, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03920930    
Other Study ID Numbers: KneeOptOut2
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

Layout table for additional information
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:
Layout table for MeSH terms
Joint Diseases
Postoperative Complications
Pathologic Processes
Musculoskeletal Diseases