Evaluation of a Fast-track Knee Arthroplasty Concept

NCT03114306 | Completed DMC

• 1 other identifier: KneeOptOut
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthropathy; Postoperative Pain; Postoperative Complications

Keywords

ERAS; pain; knee arthroplasty; joint pain; regional anaesthesia

Outcome Measures

Primary Outcomes (1)

• time to first mobilisation (standing)

  time from end of surgery until patients is able to stand

  up to 48h postoperatively

Secondary Outcomes (8)

• patients satisfaction (11-point likert scale)

  up to 7 days postoperatively

• time to first mobilisation (walking)

  up to 7 days postoperatively

• complications

  up to 7 days postoperatively

• time to achieve full joint mobility

  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

Study Arms (2)

local infiltration analgesia

EXPERIMENTAL

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

Regional anaesthesia

ACTIVE COMPARATOR

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

Interventions

local infiltration analgesia PROCEDURE

Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.

Also known as: LIA technique

local infiltration analgesia

regional-anaesthesiological catheter analgesia PROCEDURE

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.

Regional anaesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective, primary knee joint replacement in combined general anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité University Berlin (CCM)

Berlin, 13353, Germany

Location

Related Publications (4)

• 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.

  PMID: 17464601 BACKGROUND

• 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.

  PMID: 16950075 BACKGROUND

• 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.

  PMID: 30562225 RESULT

• 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.

  PMID: 35337268 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications; Pain; Arthralgia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Sascha Treskatsch, Prof.

  Charite University Berlin, Department of anaesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and treating physicians are different in this trial, that means, the assessor of primary study endpoint will be blinded regarding group allocation. Patients receive either regional-anaesthesiological catheters preoperatively or are treatet with local infiltration technique perioperatively. For the purpose of this trial is would not be feasable to perform sham regional-anaesthesiological procedures and blinding of the treating physisican will not be possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 14, 2017
• Study Start: April 5, 2017
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)