Optimization of a Fast-track Concept for Knee Joint Replacement (KneeOptOut2)

• ClinicalTrials.gov Identifier: NCT03920930
• Recruitment Status: Recruiting
• First Posted: April 19, 2019
• Last Update Posted: July 25, 2019
• Sponsor: Charite University, Berlin, Germany
• Information provided by (Responsible Party): Sascha Treskatsch, Charite University, Berlin, Germany

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Knee Arthropathy; Postoperative Pain; Postoperative Complications	Procedure: Late local infiltration analgesia; Procedure: Early local infiltration analgesia	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes 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 early or late local infiltration technique perioperatively. Patients will be blinded against early or late local infiltration technique. Blinding of the treating physician will not be possible.
• Primary Purpose: Treatment
• Official Title: Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial
• Actual Study Start Date: March 1, 2019
• Estimated Primary Completion Date: February 28, 2020
• Estimated Study Completion Date: July 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Early-intraoperative Local infiltration technique; A 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.	Procedure: Early local infiltration analgesia; 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.; Other Name: early LIA
Active Comparator: Late-intraoperative Local infiltration technique; A 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.	Procedure: Late local infiltration analgesia; Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.; Other Name: late LIA

Outcome Measures

Primary Outcome Measures :

1. Opioid consumption [ Time Frame: intraoperative, up to 3 hours ]
   amount of opioids administered intraoperative measured as equivalent dose to morphin

Secondary Outcome Measures :

1. time to first mobilisation (standing) [ Time Frame: up to 48 hours postoperatively ]
   time from end of surgery until patients is able to stand
2. patients satisfaction (11-point likert scale) [ Time Frame: up to 7 days postoperatively ]
   global satisfaction of patients
3. time to first mobilisation (walking) [ Time Frame: up to 7 days postoperatively ]
   time from end of surgery until patients is able to walk
4. time to achieve full joint mobility [ Time Frame: up to 7 days postoperatively ]
   time to achieve full joint mobility (0/0/90°)
5. Janda grade of both legs at first day after surgery [ Time Frame: up to 24h postoperatively ]
   best Janda grade in both legs the day after surgery
6. Pain intensity [ Time Frame: up to 7 days postoperatively ]
   intensity of pain in all patients meausered by numeric rating scale (NRS)
7. rescue pain medication [ Time Frame: up to 7 days postoperatively ]
   number of patients requiring rescue pain medication
8. time to discharge [ Time Frame: up to 14 days postoperatively ]
   time to discharge from hospital
9. Opioid consumption (hospital) [ Time Frame: up to 14 days postoperatively ]
   amount of opioids administered until discharge measured as equivalent dose to morphin
10. delirium [ Time Frame: up to 7 days postoperatively ]
    incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc)
11. postoperative nausea and vomiting (PONV) [ Time Frame: up to 7 days postoperatively ]
    incidence of PONV
12. surgeon satisfaction (6-point likert scale) [ Time Frame: intraoperative, up to 3 hours ]
    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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Sascha Treskatsch, MD, Prof; 004930450631011; sascha.treskatsch@charite.de

Locations

Germany

Charité - Universitätsmedizin Berlin; Recruiting

Berlin, Germany, 10117

Contact: Sascha Treskatsch, MD, Prof 004930450631 ext 011 sascha.treskatsch@charite.de

Sub-Investigator: Martin Ertmer, MD

Sub-Investigator: Ralf F Trauzeddel, MD

Sponsors and Collaborators

Charite University, Berlin, Germany

More Information

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. Review. German.

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.

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.

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.

Kastelik J, Fuchs M, Krämer 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.

• Responsible Party: Sascha Treskatsch, Prof. Dr. med., Head of Department, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT03920930
• Other Study ID Numbers: KneeOptOut2
• First Posted: April 19, 2019
• Last Update Posted: July 25, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sascha Treskatsch, Charite University, Berlin, Germany:

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

Additional relevant MeSH terms:

Joint Diseases; Postoperative Complications; Pathologic Processes; Musculoskeletal Diseases