Optimization of a Fast-track Concept for Knee Joint Replacement

Not Applicable

Completed

• Conditions: Postoperative Complications; Knee Arthropathy; Postoperative Pain
• Interventions: Procedure: Late local infiltration analgesia; Procedure: Early local infiltration analgesia

• Registration Number: NCT03920930
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-19
• Primary Completion: 2021-02-28
• Study Completion: 2021-07-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late-intraoperative Local infiltration technique	Late local infiltration analgesia	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.
Early-intraoperative Local infiltration technique	Early local infiltration analgesia	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.

Primary Outcome Measures

Name	Time	Method
Opioid consumption	intraoperative, up to 3 hours	amount of opioids administered intraoperative measured as equivalent dose to morphin

Secondary Outcome Measures

Name	Time	Method
time to first mobilisation (standing)	up to 48 hours postoperatively	time from end of surgery until patients is able to stand
rescue pain medication	up to 7 days postoperatively	number of patients requiring rescue pain medication
time to first mobilisation (walking)	up to 7 days postoperatively	time from end of surgery until patients is able to walk
Opioid consumption (hospital)	up to 14 days postoperatively	amount of opioids administered until discharge measured as equivalent dose to morphin
patients satisfaction (11-point likert scale)	up to 7 days postoperatively	global satisfaction of patients
Janda grade of both legs at first day after surgery	up to 24h postoperatively	best Janda grade in both legs the day after surgery
Pain intensity	up to 7 days postoperatively	intensity of pain in all patients meausered by numeric rating scale (NRS)
time to discharge	up to 14 days postoperatively	time to discharge from hospital
surgeon satisfaction (6-point likert scale)	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
delirium	up to 7 days postoperatively	incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc)
time to achieve full joint mobility	up to 7 days postoperatively	time to achieve full joint mobility (0/0/90°)
postoperative nausea and vomiting (PONV)	up to 7 days postoperatively	incidence of PONV

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany