Clinical trial NCT03920930: Optimization of a Fast-track Concept for Knee Joint Replacement
Official title: Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Postoperative Pain
Postoperative Complications
Keywords: ERAS
pain
knee arthroplasty
joint pain
regional anaesthesia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Opioid consumption
timeFrame: intraoperative, up to 3 hours
Secondary outcomes:
measure: time to first mobilisation (standing)
timeFrame: up to 48 hours postoperatively
measure: patients satisfaction (11-point likert scale)
timeFrame: up to 7 days postoperatively
measure: time to first mobilisation (walking)
timeFrame: up to 7 days postoperatively
measure: time to achieve full joint mobility
timeFrame: up to 7 days postoperatively
measure: Janda grade of both legs at first day after surgery
timeFrame: up to 24h postoperatively
measure: Pain intensity
timeFrame: up to 7 days postoperatively
measure: rescue pain medication
timeFrame: up to 7 days postoperatively
measure: time to discharge
timeFrame: up to 14 days postoperatively
measure: Opioid consumption (hospital)
timeFrame: up to 14 days postoperatively
measure: delirium
timeFrame: up to 7 days postoperatively
measure: postoperative nausea and vomiting (PONV)
timeFrame: up to 7 days postoperatively
measure: surgeon satisfaction (6-point likert scale)
timeFrame: intraoperative, up to 3 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References:
citation: Morin AM, Wulf H. [High volume local infiltration analgesia (LIA) for total hip and knee arthroplasty: a brief review of the current status]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2011 Feb;46(2):84-6. doi: 10.1055/s-0031-1272875. Epub 2011 Feb 10. German.
citation: Perret M, Fletcher P, Firth L, Yates P. Comparison of patient outcomes in periarticular and intraarticular local anaesthetic infiltration techniques in total knee arthroplasty. J Orthop Surg Res. 2015 Jul 31;10:119. doi: 10.1186/s13018-015-0249-x.
citation: Peters CL, Shirley B, Erickson J. The effect of a new multimodal perioperative anesthetic regimen on postoperative pain, side effects, rehabilitation, and length of hospital stay after total joint arthroplasty. J Arthroplasty. 2006 Sep;21(6 Suppl 2):132-8. doi: 10.1016/j.arth.2006.04.017.
citation: Suthersan M, Pit S, Gordon L, Loman M, Pezzutti B, Freihaut R. Local infiltration analgesia versus standard analgesia in total knee arthroplasty. J Orthop Surg (Hong Kong). 2015 Aug;23(2):198-201. doi: 10.1177/230949901502300217.
citation: Kastelik J, Fuchs M, Kramer M, Trauzeddel RF, Ertmer M, von Roth P, Perka C, Kirschbaum SM, Tafelski S, Treskatsch S. Local infiltration anaesthesia versus sciatic nerve and adductor canal block for fast-track knee arthroplasty: A randomised controlled clinical trial. Eur J Anaesthesiol. 2019 Apr;36(4):255-263. doi: 10.1097/EJA.0000000000000929.