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

NCT05313269 | Completed

• 1 other identifier: 21-0258-A
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Catheter dislodgement

  Rate of migration of the catheter tip to outside the adductor canal, verified by ultrasound assessment

  24 hours

Secondary Outcomes (7)

• Pain intensity

  24 and 48 hours

• Opioid consumption

  24 and 48 hours

• Number of attempts for catheter insertion

  4 hours

• Incidence of catheter insertion related complications

  4 hours

• Potential complications related to continuous adductor canal block catheter

  24 and 48 hours

Study Arms (2)

ISAFE technique

EXPERIMENTAL

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

Other: ISAFE technique for adductor canal catheter insertion

Conventional technique

ACTIVE COMPARATOR

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

Other: Conventional technique for adductor canal catheter insertion

Interventions

ISAFE technique for adductor canal catheter insertion OTHER

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

Also known as: ISAFE approach

ISAFE technique

Conventional technique for adductor canal catheter insertion OTHER

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

Also known as: Conventional approach

Conventional technique

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary or revision Total Knee Arthroplasty in the inpatient setting. Non-pregnant patients older than 21 years of age, with American Society of Anesthesiologists (ASA) physical status I-IV.

You may not qualify if:

• Patients undergoing outpatient TKA. Chronic opioid use of oral morphine 30mg equivalent per day for last 2 consecutive weeks. Patients with contraindications to the insertion of an adductor canal catheter (severe anatomic abnormalities, local or systemic infection, or a history of previous surgery at the site of catheter placement).

Sponsors & Collaborators

• University of Toronto: lead
• Mount Sinai Hospital, Canada: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (8)

• Price AJ, Alvand A, Troelsen A, Katz JN, Hooper G, Gray A, Carr A, Beard D. Knee replacement. Lancet. 2018 Nov 3;392(10158):1672-1682. doi: 10.1016/S0140-6736(18)32344-4.

  PMID: 30496082 BACKGROUND

• Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.

  PMID: 28283810 BACKGROUND

• Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.

  PMID: 29721648 BACKGROUND

• Yu R, Wang H, Zhuo Y, Liu D, Wu C, Zhang Y. Continuous adductor canal block provides better performance after total knee arthroplasty compared with the single-shot adductor canal block?: An updated meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Oct 23;99(43):e22762. doi: 10.1097/MD.0000000000022762.

  PMID: 33120783 BACKGROUND

• Leung P, Dickerson DM, Denduluri SK, Mohammed MK, Lu M, Anitescu M, Luu HH. Postoperative continuous adductor canal block for total knee arthroplasty improves pain and functional recovery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:46-52. doi: 10.1016/j.jclinane.2018.06.004. Epub 2018 Jun 8.

  PMID: 29890381 BACKGROUND

• Edwards RM, Currigan DA, Bradbeer S, Mitchell C. Does a catheter over needle system reduce infusate leak in continuous peripheral nerve blockade: a randomised controlled trial. Anaesth Intensive Care. 2018 Sep;46(5):468-473. doi: 10.1177/0310057X1804600507.

  PMID: 30189820 BACKGROUND

• Dos Santos Fernandes H, Siddiqui N, Peacock S, Vidal E, Wolfstadt J, Gleicher Y. Inter-fascial space between SArtorius muscle and FEmoral artery (ISAFE): A suggested approach for Adductor Canal catheter placement. J Clin Anesth. 2022 Feb;76:110571. doi: 10.1016/j.jclinane.2021.110571. Epub 2021 Nov 8. No abstract available.

  PMID: 34763273 BACKGROUND

• Sun C, Zhang X, Song F, Zhao Z, Du R, Wu S, Ma Q, Cai X. Is continuous catheter adductor canal block better than single-shot canal adductor canal block in primary total knee arthroplasty?: A GRADE analysis of the evidence through a systematic review and meta-analysis. Medicine (Baltimore). 2020 May;99(20):e20320. doi: 10.1097/MD.0000000000020320.

  PMID: 32443383 BACKGROUND

Study Officials

• Yehoshua Gleicher, MD, MSc

  University of Toronto

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 6, 2022
• Study Start: April 28, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 28, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: At the conclusion of the study

Locations

CA (1)