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Inter-fascial Plane Between the SArtorius Muscle and FEmoral Artery (ISAFE)

NCT05313269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-06-06

No results posted yet for this study

Summary

Total knee arthroplasty (TKA) is a frequent performed surgery. Adequate pain management is an important feature. Analgesic duration of single shot nerve blocks is limited to no more than 24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and infusion of local anesthetic may increase duration of analgesia and provide better outcomes. Continuous adductor canal block (CACB) has been proven superior when compared to single-injection adductor canal block (SACB) for TKA analgesia. However, safety concerns such as intravenous insertion, nerve injury, or catheter displacement must always be considered. The purpose of this study is to evaluate the Inter-fascial Plane between SArtorius Muscle and FEmoral Artery (ISAFE) approach for adductor canal catheter placement, in terms of catheter dislodgment, clinical effectiveness and complications, in comparison with the classical approach, as TKA postoperative analgesia modality. We hypothesize that ISAFE approach can result in a smaller rate of dislodgments in the way that it increases the clinical benefit of CACB.

Conditions

  • Anesthesia, Conduction
  • Arthroplasty, Replacement, Knee

Interventions

OTHER

ISAFE technique for adductor canal catheter insertion

Adductor canal block catheter tip located in the fascial plane between sartorious muscle and femoral artery.

OTHER

Conventional technique for adductor canal catheter insertion

Adductor canal block catheter tip located lateral to the femoral artery.

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    collaborator OTHER

  • University of Toronto

    lead OTHER

Principal Investigators

  • Yehoshua Gleicher, MD, MSc · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-02-28
Completion
2023-03-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05313269 on ClinicalTrials.gov