Optimization of a Fast-track Concept for Knee Joint Replacement

NCT03920930 | Completed DMC

• 1 other identifier: KneeOptOut2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthropathy; Postoperative Pain; Postoperative Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  amount of opioids administered intraoperative measured as equivalent dose to morphin

  intraoperative, up to 3 hours

Secondary Outcomes (12)

• time to first mobilisation (standing)

  up to 48 hours postoperatively

• patients satisfaction (11-point likert scale)

  up to 7 days postoperatively

• time to first mobilisation (walking)

  up to 7 days postoperatively

• time to achieve full joint mobility

  up to 7 days postoperatively

• Janda grade of both legs at first day after surgery

  up to 24h postoperatively

Study Arms (2)

Early-intraoperative Local infiltration technique

EXPERIMENTAL

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

Late-intraoperative Local infiltration technique

ACTIVE COMPARATOR

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

Interventions

Late local infiltration analgesia PROCEDURE

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

Also known as: late LIA

Late-intraoperative Local infiltration technique

Early local infiltration analgesia PROCEDURE

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.

Also known as: early LIA

Early-intraoperative Local infiltration technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (5)

• 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.

  PMID: 21312140 BACKGROUND

• 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.

  PMID: 26227482 BACKGROUND

• 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.

  PMID: 16950075 BACKGROUND

• 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.

  PMID: 26321550 BACKGROUND

• 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.

  PMID: 30562225 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications; Pain; Arthralgia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med., Head of Department

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: March 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: July 30, 2021
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

DE (1)