Evaluation of a Fast-track Knee Arthroplasty Concept

Not Applicable

Completed

• Conditions: Knee Arthropathy; Postoperative Complications; Postoperative Pain
• Interventions: Procedure: regional-anaesthesiological catheter analgesia; Procedure: local infiltration analgesia

• Registration Number: NCT03114306
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2017-03-27
• Study Start: 2017-04-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Primary Completion: 2017-08-30
• Study Completion: 2017-08-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-11
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regional anaesthesia	regional-anaesthesiological catheter analgesia	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).
local infiltration analgesia	local infiltration analgesia	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.

Primary Outcome Measures

Name	Time	Method
time to first mobilisation (standing)	up to 48h postoperatively	time from end of surgery until patients is able to stand

Secondary Outcome Measures

Name	Time	Method
complications	up to 7 days postoperatively	complications during perioperative care process (e.g. thrombosis, re-operation, infection)
time to achieve full joint mobility	up to 7 days postoperatively	time to achieve full joint mobility (0/0/90°)
rescue pain medication	up to 7 days postoperatively	number of patients requiring rescue pain medication
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
pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean)	up to 7 days postoperatively	mean pain intensity of patients
pain medication perioperatively	up to 7 days postoperatively	pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics)
time to discharge	up to 14 days postoperatively	time to discharge from hospital

Trial Locations

Locations (1)

Charité University Berlin (CCM); 🇩🇪 Berlin, Germany