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Knee ArthropathyKneeOptOut2NCT03920930

Optimization of a Fast-track Concept for Knee Joint Replacement

A study testing Late local infiltration analgesia and Early local infiltration analgesia in people with Knee Arthropathy and Postoperative Pain, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In an estimated 150,000 patients, a knee joint replacement is performed in Germany every year. The perioperative care of the patients aims at an optimal surgical technique, which leads to a high functionality in the joint, and above all at an adequate pain treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Late local infiltration analgesia and Early local infiltration analgesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteGermany
Study dates
1 Mar 2019to 30 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • heart insufficiency NYHA >2
  • liver insufficiency > CHILD B
  • evidence of diabetic polyneuropathy
  • severe adipositas BMI >40
  • patients < 18 years
  • pregnancy
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

Germany1 site

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

Other trials in Germany

About this study

Official title: Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial

In an estimated 150,000 patients, a knee joint replacement is performed in Germany every year. The perioperative care of the patients aims at an optimal surgical technique, which leads to a high functionality in the joint, and above all at an adequate pain treatment. Patients experience pain especially intraoperatively and in the first days after the operation. The intensity of pain is a decisive factor that can hinder the patient's mobilization. In the KneeOptOut study (ethics application number EA4/009/17), which has already been successfully carried out and approved by this ethics committee, it was shown that the use of local infiltration anaesthesia (LIA) for pain therapy after primary knee endoprosthetics is comparable to catheter-supported regional anaesthesia (manuscript under review at the European Journal of Anaesthesiology). During surgery, the morphine requirement of patients in the LIA group was significantly higher than that of patients who underwent catheterization. Postoperatively, however, both subjective pain by VAS and opiate consumption were comparable.

In order to optimize the intraoperative opiate need/consumption, an early-intraoperative procedure for local infiltration anesthesia will now be compared with the previous late-intraoperative procedure. Both procedures correspond to SOP for the treatment of primary knee endoprostheses and are currently used depending on the surgeon's requirements.

Being tested
Late local infiltration analgesia, Early local infiltration analgesia
Keywords
ERAS, pain, knee arthroplasty, joint pain, regional anaesthesia
Medical subject headings
Pain, Postoperative, Postoperative Complications, Pain, Arthralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Late local infiltration analgesiaProcedure or surgery

    Also called late LIA

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

  • Early local infiltration analgesiaProcedure or surgery

    Also called early LIA

    The local infiltration analgesia is applied in a total of 4 steps during the preparation of the knee joint: 1. after the skin incision, 2. after the capsule incision, 3. after complete exposure of the knee joint, 4. when the posterior knee capsule is reached.

Study groups in NCT03920930
Study groupRoleWhat they receive
Early-intraoperative Local infiltration techniqueExperimentalA distal regional anaesthesia is performed in which the nerves are blocked by a local anaesthetic in the tissue in the immediate vicinity of the operating area ("tissue infiltration technique"). The LIA is applied in a total of 4 steps during the preparation of the knee joint: 1. after the skin incision, 2. after the capsule incision, 3. after complete exposure of the knee joint, 4. when the posterior knee capsule is reached.
Receives: Procedure: Early local infiltration analgesia
Late-intraoperative Local infiltration techniqueActive comparatorA distal regional anaesthesia is performed in which the nerves are blocked by a local anaesthetic in the tissue in the immediate vicinity of the operating area ("tissue infiltration technique"). The LIA is applied after the preparation of the femur and tibia bone shortly before the prosthesis is inserted and during the retreat from the knee joint.
Receives: Procedure: Late local infiltration analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid consumption

    amount of opioids administered intraoperative measured as equivalent dose to morphin

    Measured: intraoperative, up to 3 hours

Secondary outcomes (12)

  1. time to first mobilisation (standing)

    time from end of surgery until patients is able to stand

    Measured: up to 48 hours postoperatively

  2. patients satisfaction (11-point likert scale)

    global satisfaction of patients

    Measured: up to 7 days postoperatively

  3. time to first mobilisation (walking)

    time from end of surgery until patients is able to walk

    Measured: up to 7 days postoperatively

  4. time to achieve full joint mobility

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

    Measured: up to 7 days postoperatively

  5. Janda grade of both legs at first day after surgery

    best Janda grade in both legs the day after surgery

    Measured: up to 24h postoperatively

  6. Pain intensity

    intensity of pain in all patients meausered by numeric rating scale (NRS)

    Measured: up to 7 days postoperatively

  7. rescue pain medication

    number of patients requiring rescue pain medication

    Measured: up to 7 days postoperatively

  8. time to discharge

    time to discharge from hospital

    Measured: up to 14 days postoperatively

  9. Opioid consumption (hospital)

    amount of opioids administered until discharge measured as equivalent dose to morphin

    Measured: up to 14 days postoperatively

  10. delirium

    incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc)

    Measured: up to 7 days postoperatively

  11. postoperative nausea and vomiting (PONV)

    incidence of PONV

    Measured: up to 7 days postoperatively

  12. surgeon satisfaction (6-point likert scale)

    satisfaction of surgeon in points of clarity of the operative field, change of the operative field by LIA and overall satisfaction represented in one value

    Measured: intraoperative, up to 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2019
  2. Study start1 Mar 2019
  3. Primary completion28 Feb 2021
  4. Study completion30 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03920930
Sponsor's protocol ID
KneeOptOut2
Acronym
KneeOptOut2
Status last verified
Feb 2023
First submitted
16 Apr 2019
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Morin AM, Wulf H. [High volume local infiltration analgesia (LIA) for total hip and knee arthroplasty: a brief review of the current status]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2011 Feb;46(2):84-6. doi: 10.1055/s-0031-1272875. Epub 2011 Feb 10. German.

    PubMed 21312140

  • Perret M, Fletcher P, Firth L, Yates P. Comparison of patient outcomes in periarticular and intraarticular local anaesthetic infiltration techniques in total knee arthroplasty. J Orthop Surg Res. 2015 Jul 31;10:119. doi: 10.1186/s13018-015-0249-x.

    PubMed 26227482

  • 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.

    PubMed 16950075

  • Suthersan M, Pit S, Gordon L, Loman M, Pezzutti B, Freihaut R. Local infiltration analgesia versus standard analgesia in total knee arthroplasty. J Orthop Surg (Hong Kong). 2015 Aug;23(2):198-201. doi: 10.1177/230949901502300217.

    PubMed 26321550

  • 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.

    PubMed 30562225

Questions about this trial

What is this clinical trial studying?

A study testing Late local infiltration analgesia and Early local infiltration analgesia in people with Knee Arthropathy and Postoperative Pain, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid consumption (time frame: intraoperative, up to 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03920930, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

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