Knee Arthropathy, Postoperative Complications, Postoperative Pain
Conditions
Keywords
ERAS, pain, knee arthroplasty, joint pain, regional anaesthesia
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.
Interventions
PROCEDURELate local infiltration analgesia
Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
PROCEDUREEarly 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.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Investigator and treating physicians are different in this trial, that means, the assessor of primary study endpoint will be blinded regarding group allocation. Patients receive either early or late local infiltration technique perioperatively. Patients will be blinded against early or late local infiltration technique. Blinding of the treating physician will not be possible.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | intraoperative, up to 3 hours | amount of opioids administered intraoperative measured as equivalent dose to morphin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative nausea and vomiting (PONV) | up to 7 days postoperatively | incidence of PONV |
| delirium | up to 7 days postoperatively | incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc) |
| Pain intensity | up to 7 days postoperatively | intensity of pain in all patients meausered by numeric rating scale (NRS) |
| rescue pain medication | up to 7 days postoperatively | number of patients requiring rescue pain medication |
| time to discharge | up to 14 days postoperatively | time to discharge from hospital |
| Opioid consumption (hospital) | up to 14 days postoperatively | amount of opioids administered until discharge measured as equivalent dose to morphin |
| time to first mobilisation (standing) | up to 48 hours postoperatively | time from end of surgery until patients is able to stand |
| patients satisfaction (11-point likert scale) | up to 7 days postoperatively | global satisfaction of patients |
| time to first mobilisation (walking) | up to 7 days postoperatively | time from end of surgery until patients is able to walk |
| time to achieve full joint mobility | up to 7 days postoperatively | time to achieve full joint mobility (0/0/90°) |
| Janda grade of both legs at first day after surgery | up to 24h postoperatively | best Janda grade in both legs the day after surgery |
| 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 |
Countries
Germany
Outcome results
None listed