Knee ArthropathyKneeOptOutNCT03114306
Evaluation of a Fast-track Knee Arthroplasty Concept
A study testing local infiltration analgesia and regional-anaesthesiological catheter analgesia in people with Knee Arthropathy and Postoperative Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthropathy, Postoperative Pain, Postoperative Complications
- What is being tested?
- local infiltration analgesia and regional-anaesthesiological catheter analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 5 Apr 2017to 30 Aug 2017
- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- local infiltration analgesia, regional-anaesthesiological catheter 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.
local infiltration analgesiaProcedure or surgery
Also called LIA technique
Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
regional-anaesthesiological catheter analgesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: regional-anaesthesiological catheter analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first mobilisation (standing)
time from end of surgery until patients is able to stand
Measured: up to 48h postoperatively
Secondary outcomes (8)
patients satisfaction (11-point likert scale)
global satisfaction of patients
Measured: up to 7 days postoperatively
time to first mobilisation (walking)
time from end of surgery until patients is able to walk
Measured: up to 7 days postoperatively
complications
complications during perioperative care process (e.g. thrombosis, re-operation, infection)
Measured: up to 7 days postoperatively
time to achieve full joint mobility
time to achieve full joint mobility (0/0/90°)
Measured: 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
Measured: up to 7 days postoperatively
rescue pain medication
number of patients requiring rescue pain medication
Measured: up to 7 days postoperatively
pain medication perioperatively
pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics)
Measured: up to 7 days postoperatively
time to discharge
time to discharge from hospital
Measured: up to 14 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start5 Apr 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Treskatsch, Charite University, Berlin, Germany
- Investigators
- Sascha Treskatsch, Prof., Principal investigator, Charite University Berlin, Department of anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114306
- Sponsor's protocol ID
- KneeOptOut
- Acronym
- KneeOptOut
- Status last verified
- Feb 2024
- First submitted
- 27 Mar 2017
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual requests to analyse data are to be evaluated by local data safety authorities
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.
PubMed 17464601Peters 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 16950075Kastelik 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 30562225Borck 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.
PubMed 35337268
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Fast-track Knee Arthroplasty Concept: a Randomized, Controlled, Open Clinical Trial
- ClinicalTrials.gov ID
- NCT03114306
- Acronym / sponsor ID
- KneeOptOut / KneeOptOut
- Keywords
- ERAS, pain, knee arthroplasty, joint pain, regional anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local infiltration analgesia | Experimental | Procedure: local infiltration analgesiaPatient 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. |
| Regional anaesthesia | Active comparator | Procedure: regional-anaesthesiological catheter analgesiaPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective, primary knee joint replacement in combined general anaesthesia
Key exclusion criteria (10 listed)
- heart insufficiency NYHA >2
- liver insufficiency > CHILD B
- evidence of diabetic polyneuropathy
- severe adipositas BMI >40
- patients < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local infiltration analgesiaAlso: LIA techniquePatient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control. | Procedure or surgery | local infiltration analgesia |
| regional-anaesthesiological catheter analgesiaPatients 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. | Procedure or surgery | Regional anaesthesia |
Primary outcome
time to first mobilisation (standing)
Time frame: up to 48h postoperatively
time from end of surgery until patients is able to stand
8 secondary outcomes
patients satisfaction (11-point likert scale)
Time frame: up to 7 days postoperatively
time to first mobilisation (walking)
Time frame: up to 7 days postoperatively
complications
Time frame: up to 7 days postoperatively
time to achieve full joint mobility
Time frame: up to 7 days postoperatively
pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean)
Time frame: up to 7 days postoperatively
rescue pain medication
Time frame: up to 7 days postoperatively
pain medication perioperatively
Time frame: up to 7 days postoperatively
time to discharge
Time frame: up to 14 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 17464601Rostlund 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.
- Background: PubMed 16950075Peters 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.
- Results publication: PubMed 30562225Kastelik 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.
- Results publication: PubMed 35337268Borck 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.
- Individual participant dataSharing planned: No. Individual requests to analyse data are to be evaluated by local data safety authorities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sascha Treskatsch, Prof. principal investigator
Charite University Berlin, Department of anaesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local infiltration analgesia and regional-anaesthesiological catheter 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 13 Feb 2024. 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?
time to first mobilisation (standing) (time frame: up to 48h postoperatively). 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 NCT03114306, which also lists 4 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 13 Feb 2024.