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OpenTrials
Completed

NCT Number: NCT03920930

Optimization of a Fast-track Concept for Knee Joint Replacement

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Late local infiltration analgesia

Procedure

Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.

Other names: late LIA

Early local infiltration analgesia

Procedure

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 names: early LIA

Primary outcomes

  1. Opioid consumption

    Time frame: intraoperative, up to 3 hours

    amount of opioids administered intraoperative measured as equivalent dose to morphin

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial

Acronym: KneeOptOut2

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2019
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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