Evaluation of a Fast-track Knee Arthroplasty Concept

NCT ID: NCT03114306

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-05
• Study Completion Date: 2017-08-30

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.

Conditions

Knee Arthropathy; Postoperative Pain; Postoperative Complications

Study Design

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

Study Groups

local infiltration analgesia

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.

Group Type: EXPERIMENTAL

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.

Regional 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).

Group Type: ACTIVE_COMPARATOR

regional-anaesthesiological catheter analgesia

Intervention Type: PROCEDURE

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.

Interventions

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

regional-anaesthesiological catheter analgesia

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.

Intervention Type: PROCEDURE

Other Intervention Names

LIA technique

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

Head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sascha Treskatsch, Prof.

Role: PRINCIPAL_INVESTIGATOR

Charite University Berlin, Department of anaesthesia

Locations

Charité University Berlin (CCM)

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 17464601 (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)

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: RESULT

PMID: 30562225 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35337268 (View on PubMed)

Other Identifiers

KneeOptOut

Identifier Type: -

Identifier Source: org_study_id