NCT03920930: KneeOptOut2

Optimization of a Fast-track Concept for Knee Joint Replacement

Completed NA Last updated 14 February 2023

What this trial tests

NA trial testing Late local infiltration analgesia in Knee Arthropathy in 70 participants. Completed in 30 July 2021.

Timeline

1 March 2019

Primary endpoint
28 February 2021

30 July 2021

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	70
Start date	1 March 2019
Primary completion	28 February 2021
Estimated completion	30 July 2021
Sites	1 location across Germany

Drugs / interventions tested

• Late local infiltration analgesia
• Early local infiltration analgesia

Conditions studied

• Knee Arthropathy — all drugs for Knee Arthropathy →
• Postoperative Pain — all drugs for Postoperative Pain →
• Postoperative Complications — all drugs for Postoperative Complications →

Sponsor

Charite University, Berlin, Germany

Who can join

18 and older, any sex, with Knee Arthropathy or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.