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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Optimization of a Fast-track Concept for Knee Joint Replacement

Clinicaltrials.gov identifier NCT03920930

Recruitment Status Recruiting

First Posted April 19, 2019

Last update posted July 25, 2019

Study Description

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:Knee Arthropathy
    Postoperative Pain
    Postoperative Complications
  • Intervention/Treatment: Procedure: Late local infiltration analgesia
    Procedure: Early local infiltration analgesia
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 70 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • 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 2019
  • Estimated Primary Completion Date: February 2020
  • Estimated Study Completion Date: July 2020
Arms and interventions
Arm Intervention/treatment
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.
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.
Outcome Measures
  • 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 achieve full joint mobility [ Time Frame: up to 7 days postoperatively ]
    time to achieve full joint mobility (0/0/90°)
  • 2. time to first mobilisation (standing) [ Time Frame: up to 48 hours postoperatively ]
    time from end of surgery until patients is able to stand
  • 3. patients satisfaction (11-point likert scale) [ Time Frame: up to 7 days postoperatively ]
    global satisfaction of patients
  • 4. time to first mobilisation (walking) [ Time Frame: up to 7 days postoperatively ]
    time from end of surgery until patients is able to walk
  • 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
Eligibility Criteria
  • 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 3 months before scheduled surgery

- allergy against medication required for surgery or anaesthesia

Contacts and Locations
Contacts

Contact: Sascha Treskatsch, MD, Prof 004930450631011 sascha.treskatsch@charite.de

Locations

Germany
Charité - Universitätsmedizin Berlin
Berlin

Sponsors and Collaborators

Charite University, Berlin, Germany

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