Optimization of a Fast-track Concept for Knee Joint Replacement

NCT ID: NCT03920930

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-07-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Early local infiltration analgesia

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Late local infiltration analgesia

Intervention Type: PROCEDURE

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

Interventions

Late local infiltration analgesia

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

late LIA; early LIA

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Sascha Treskatsch

Prof. Dr. med., Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 21312140 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26227482 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16950075 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26321550 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30562225 (View on PubMed)

Other Identifiers

KneeOptOut2

Identifier Type: -

Identifier Source: org_study_id