Evaluation of a Fast-track Knee Arthroplasty Concept (KneeOptOut)
Primary Purpose
Knee Arthropathy, Postoperative Pain, Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
local infiltration analgesia
regional-anaesthesiological catheter analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Knee Arthropathy focused on measuring ERAS, pain, knee arthroplasty, joint pain, regional anaesthesia
Eligibility Criteria
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
Sites / Locations
- Charité University Berlin (CCM)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
local infiltration analgesia
Regional anaesthesia
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
time to first mobilisation (standing)
time from end of surgery until patients is able to stand
Secondary Outcome Measures
patients satisfaction (11-point likert scale)
global satisfaction of patients
time to first mobilisation (walking)
time from end of surgery until patients is able to walk
complications
complications during perioperative care process (e.g. thrombosis, re-operation, infection)
time to achieve full joint mobility
time to achieve full joint mobility (0/0/90°)
pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean)
mean pain intensity of patients
rescue pain medication
number of patients requiring rescue pain medication
pain medication perioperatively
pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics)
time to discharge
time to discharge from hospital
Full Information
NCT ID
NCT03114306
First Posted
March 27, 2017
Last Updated
July 23, 2019
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT03114306
Brief Title
Evaluation of a Fast-track Knee Arthroplasty Concept
Acronym
KneeOptOut
Official Title
Implementation of a Fast-track Knee Arthroplasty Concept: a Randomized, Controlled, Open Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy, Postoperative Pain, Postoperative Complications
Keywords
ERAS, pain, knee arthroplasty, joint pain, regional anaesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
local infiltration analgesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Regional anaesthesia
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
local infiltration analgesia
Other Intervention Name(s)
LIA technique
Intervention Description
Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
Intervention Type
Procedure
Intervention Name(s)
regional-anaesthesiological catheter analgesia
Intervention Description
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 Outcome Measure Information:
Title
time to first mobilisation (standing)
Description
time from end of surgery until patients is able to stand
Time Frame
up to 48h postoperatively
Secondary Outcome Measure Information:
Title
patients satisfaction (11-point likert scale)
Description
global satisfaction of patients
Time Frame
up to 7 days postoperatively
Title
time to first mobilisation (walking)
Description
time from end of surgery until patients is able to walk
Time Frame
up to 7 days postoperatively
Title
complications
Description
complications during perioperative care process (e.g. thrombosis, re-operation, infection)
Time Frame
up to 7 days postoperatively
Title
time to achieve full joint mobility
Description
time to achieve full joint mobility (0/0/90°)
Time Frame
up to 7 days postoperatively
Title
pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean)
Description
mean pain intensity of patients
Time Frame
up to 7 days postoperatively
Title
rescue pain medication
Description
number of patients requiring rescue pain medication
Time Frame
up to 7 days postoperatively
Title
pain medication perioperatively
Description
pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics)
Time Frame
up to 7 days postoperatively
Title
time to discharge
Description
time to discharge from hospital
Time Frame
up to 14 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sascha Treskatsch, Prof.
Organizational Affiliation
Charite University Berlin, Department of anaesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité University Berlin (CCM)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual requests to analyse data are to be evaluated by local data safety authorities
Citations:
PubMed Identifier
17464601
Citation
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.
Results Reference
background
PubMed Identifier
16950075
Citation
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.
Results Reference
background
PubMed Identifier
35337268
Citation
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.
Results Reference
derived
PubMed Identifier
30562225
Citation
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.
Results Reference
derived
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Evaluation of a Fast-track Knee Arthroplasty Concept
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