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NCT05313269: ISAFE
Inter-fascial Plane Between the SArtorius Muscle and FEmoral Artery (ISAFE)
NA trial testing ISAFE technique for adductor canal catheter insertion in Anesthesia, Conduction in 100 participants. Completed in 28 March 2023.
28 February 2023
Quick facts
| Lead sponsor | University of Toronto |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 28 April 2022 |
| Primary completion | 28 February 2023 |
| Estimated completion | 28 March 2023 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- ISAFE technique for adductor canal catheter insertion
- Conventional technique for adductor canal catheter insertion
Conditions studied
- Anesthesia, Conduction — all drugs for Anesthesia, Conduction →
- Arthroplasty, Replacement, Knee — all drugs for Arthroplasty, Replacement, Knee →
Sponsor
University of Toronto
Who can join
21 and older, any sex, with Anesthesia, Conduction or Arthroplasty, Replacement, Knee. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05313269
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05313269 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Toronto
- Last refreshed: 6 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05313269.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing