Implementation of a Fast-track Knee Arthroplasty Concept: a Randomized, Controlled, Open Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Arthropathy
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- time to first mobilisation (standing)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Sascha Treskatsch
Head of department
Charite University, Berlin, Germany
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
Outcomes
Primary Outcomes
time to first mobilisation (standing)
Time Frame: up to 48h postoperatively
time from end of surgery until patients is able to stand
Secondary Outcomes
- patients satisfaction (11-point likert scale)(up to 7 days postoperatively)
- complications(up to 7 days postoperatively)
- time to achieve full joint mobility(up to 7 days postoperatively)
- rescue pain medication(up to 7 days postoperatively)
- time to first mobilisation (walking)(up to 7 days postoperatively)
- pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean)(up to 7 days postoperatively)
- pain medication perioperatively(up to 7 days postoperatively)
- time to discharge(up to 14 days postoperatively)