NCT03920930

Optimization of a Fast-track Concept for Knee Joint Replacement

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Arthropathy
• Postoperative Pain
• Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	Late local infiltration analgesia	Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
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.

Timeline

• Start date: 2019-03-01
• Primary completion: 2021-02-28
• Completion: 2021-07-30
• First posted: 2019-04-19
• Last updated: 2023-02-14

Locations

1 site across 1 country: Germany