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OpenTrials
Completed

NCT Number: NCT03114306

Evaluation of a Fast-track Knee Arthroplasty Concept

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Berlin (CCM)

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local Infiltration Analgesia

Procedure

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

Other names: LIA technique

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.

Primary outcomes

  1. time to first mobilisation (standing)

    Time frame: up to 48h postoperatively

    time from end of surgery until patients is able to stand

Secondary outcomes

  1. patients satisfaction (11-point likert scale)

    Time frame: up to 7 days postoperatively

    global satisfaction of patients

  2. time to first mobilisation (walking)

    Time frame: up to 7 days postoperatively

    time from end of surgery until patients is able to walk

  3. complications

    Time frame: up to 7 days postoperatively

    complications during perioperative care process (e.g. thrombosis, re-operation, infection)

  4. time to achieve full joint mobility

    Time frame: up to 7 days postoperatively

    time to achieve full joint mobility (0/0/90°)

  5. pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean)

    Time frame: up to 7 days postoperatively

    mean pain intensity of patients

  6. rescue pain medication

    Time frame: up to 7 days postoperatively

    number of patients requiring rescue pain medication

  7. pain medication perioperatively

    Time frame: up to 7 days postoperatively

    pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics)

  8. time to discharge

    Time frame: up to 14 days postoperatively

    time to discharge from hospital

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: KneeOptOut

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2017
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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