Evaluation of a Fast-track Knee Arthroplasty Concept (KneeOptOut)

Charité University Medicine Berlin

Status: Completed

Conditions: Postoperative Complications; Postoperative Pain; Knee Arthropathy

Treatments: Procedure: local infiltration analgesia; Procedure: regional-anaesthesiological catheter analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03114306

KneeOptOut

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

local infiltration analgesia

Experimental group

Description:

Patient receive an infiltration of local anaesthetics around the knee to achieve maximal distal block of nerve fibres. Infiltration is performed directly after knee replacement and during weaning of general anaesthesia.

Treatment:

Procedure: local infiltration analgesia

Regional anaesthesia

Active Comparator group

Description:

Patients receive a combined anaesthesia with a regional-anaesthesiological catheter placed close to the distal Nervus saphenus and a single shot anaesthesia of Nervus ischiadicus using local anaesthetics (regional-anaesthesiological catheter analgesia).

Treatment:

Procedure: regional-anaesthesiological catheter analgesia