Clinical trial NCT03114306: Evaluation of a Fast-track Knee Arthroplasty Concept
Official title: Implementation of a Fast-track Knee Arthroplasty Concept: a Randomized, Controlled, Open 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: 2017-04-14
Enrollment: 40
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: Mobilisation following knee arthroplasty is an important aspect to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. This RCT evaluates two analgetic regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.

Detailed description: Mobilisation following knee arthroplasty is important for patients to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. There is evidence that regional- anaesthesiological catheter techniques are very efficient to control pain postoperatively. On the other hand, motoric function may be reduced due to nerve blocks depending on location and concentration of drug used. Local infiltration of the knee during surgery is an alternative component in pain management that may reduce impaired motor function and allow early mobilisation of patients. However, currently it is not known which analgesia technique provides optimal pain control paralleled with sufficient motor function. Against this background, this RCT evaluates two analgesia regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.

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: time to first mobilisation (standing)
timeFrame: up to 48h postoperatively
Secondary outcomes:
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: complications
timeFrame: up to 7 days postoperatively
measure: time to achieve full joint mobility
timeFrame: up to 7 days postoperatively
measure: pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean)
timeFrame: up to 7 days postoperatively
measure: rescue pain medication
timeFrame: up to 7 days postoperatively
measure: pain medication perioperatively
timeFrame: up to 7 days postoperatively
measure: time to discharge
timeFrame: up to 14 days postoperatively
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Berlin (CCM)
Study officials:
affiliation: Charite University Berlin, Department of anaesthesia
name: Sascha Treskatsch, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rostlund T, Kehlet H. High-dose local infiltration analgesia after hip and knee replacement--what is it, why does it work, and what are the future challenges? Acta Orthop. 2007 Apr;78(2):159-61. doi: 10.1080/17453670710013627. No abstract available.
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: 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.
citation: Borck M, Wandrey JD, Hoft M, Kastelik J, Perka C, Tafelski S, Treskatsch S. Local infiltration analgesia versus peripheral nerve block anaesthesia in total knee arthroplasty: a pharmaco-economic comparison. BMC Anesthesiol. 2022 Mar 25;22(1):80. doi: 10.1186/s12871-022-01620-w.