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

Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Pain; Knee Arthropathy
• Intervention / Treatment: Procedure: Early local infiltration analgesia; Procedure: Late local infiltration analgesia

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: late LIA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	amount of opioids administered intraoperative measured as equivalent dose to morphin	intraoperative, up to 3 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Publications and helpful links

General 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. 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. doi: 10.1016/j.arth.2006.04.017.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): February 28, 2021
• Study Completion (ACTUAL): July 30, 2021

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (ACTUAL): April 19, 2019

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: joint pain; pain; regional anaesthesia; ERAS; knee arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: KneeOptOut2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No