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

Implementation of a Fast-track Knee Arthroplasty Concept: a Randomized, Controlled, Open Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Pain; Knee Arthropathy
• Intervention / Treatment: Procedure: local infiltration analgesia; Procedure: regional-anaesthesiological catheter analgesia

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité University Berlin (CCM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: local infiltration analgesia; Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.; Other Names: LIA technique
Active Comparator: Regional anaesthesia; 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).	Procedure: regional-anaesthesiological catheter analgesia; Patients receive a single shot nerve block of the proximal Nervus ischiadicus and a catheter placed closed to the Nervus saphenus for perioperative pain control using ultrasound guided techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first mobilisation (standing)	time from end of surgery until patients is able to stand	up to 48h postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients satisfaction (11-point likert scale)	global satisfaction of patients	up to 7 days postoperatively
time to first mobilisation (walking)	time from end of surgery until patients is able to walk	up to 7 days postoperatively
complications	complications during perioperative care process (e.g. thrombosis, re-operation, infection)	up to 7 days postoperatively
time to achieve full joint mobility	time to achieve full joint mobility (0/0/90°)	up to 7 days postoperatively
pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean)	mean pain intensity of patients	up to 7 days postoperatively
rescue pain medication	number of patients requiring rescue pain medication	up to 7 days postoperatively
pain medication perioperatively	pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics)	up to 7 days postoperatively
time to discharge	time to discharge from hospital	up to 14 days postoperatively

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Sascha Treskatsch, Prof., Charite University Berlin, Department of anaesthesia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2017
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: joint pain; pain; regional anaesthesia; ERAS; knee arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: KneeOptOut

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual requests to analyse data are to be evaluated by local data safety authorities

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No