NCT07681622

Brief Summary

Continuous adductor canal block (CACB) is becoming increasingly popular for providing postoperative analgesia following knee arthroplasties. These continuous blocks are provided through inserted nerve catheters and effectively extend the duration of analgesia, thereby reducing opioid consumption. This, in turn, helps minimize opioid-related side effects, promotes early ambulation, and supports earlier discharge. However, catheter migration remains a significant concern, as the catheter tip can become displaced from the adductor canal due to movements associated with ambulation or physiotherapy. In this study, the investigators compare the migration rates of two different techniques for CACB catheters insertion: the Interfascial plane between SArtorious muscle and FEmoral artery (ISAFE) and the Out Of Plane parallel to Saphenous nerve (OOPS) techniques. Pain scores and opioid consumption on postoperative day 1 (POD1) will also be assessed as secondary outcomes. The hypothesis is that both techniques will result in similar migration rates of CACB catheter.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jun 2026Jun 2027

Study Start

First participant enrolled

June 1, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 19, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Catheter migration

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

    24 hours

Secondary Outcomes (5)

  • Pain intensity

    24 hours

  • Opioid consumption

    24 hours

  • Number of attempts for catheter insertion

    4 hours

  • Potential complications related to CACB

    24 hours

  • Incidence of sensory block

    24 hours

Study Arms (2)

ISAFE technique

ACTIVE COMPARATOR

Adductor canal block catheter inserted perpendicular to the saphenous nerve , catheter tip located in the fascial plane between sartorius muscle and femoral artery

Procedure: ISAFE technique for adductor canal catheter insertion

OOPS technique

EXPERIMENTAL

Adductor canal block catheter inserted parallel to the saphenous nerve , catheter tip located lateral to the femoral artery

Procedure: OOPS technique

Interventions

Adductor canal block catheter inserted perpendicular to the saphenous nerve , catheter tip located in the fascial plane between sartorius muscle and femoral artery

ISAFE technique

Adductor canal block catheter inserted perpendicular to the saphenous nerve , catheter tip located in the fascial plane between sartorius muscle and femoral artery

OOPS technique

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-pregnant patients older than 18 years of age;
  • Patients undergoing unilateral primary total knee arthroplasty in an inpatient regime;
  • American Society of Anesthesiologist (ASA) physical status Class I - IV patients;
  • With sufficient understanding and co-operation about usage of a perineural catheter for pain management;
  • With body mass index (BMI) under 45;
  • With no history of strong opioid use of more than 30 mg of oral morphine equivalent (OME)/day during the 2 weeks preceding the surgery;
  • No alcohol or drug use disorder history;
  • With no contra-indication for the performance of ACB and IPACK block;
  • With no contra-indication for spinal anesthesia;
  • With no contra-indication for CACB catheter insertion (local site infection, systemic infection, anatomical abnormality);
  • With no contra-indication for the medications to be used accordingly with the study protocol (ropivacaine, lidocaine, mepivacaine, midazolam, fentanyl, propofol, cefazolin, tranexamic acid, dexamethasone, ondansetron, celecoxib, acetaminophen, hydromorphone);
  • Speak and understand the English language;
  • Agree to participate on this study through the signature of the consent form.

You may not qualify if:

  • They have a failed spinal anesthesia and needs for a conversion to general anesthesia;
  • The peripheral nerve blocks are not possible to be performed due to technical difficulties;
  • A deviation of the protocol occurs (not follow the standardized postoperative analgesia orders; need an emergency re-operation of the same knee, in less than 24 hours, due to a surgical complication; have an important perioperative complication, leading to abnormal level of conscience);
  • CACB catheter has issues on its function and needs to be removed before the migration assessment
  • Patient decides to withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (12)

  • Hanson NA, Allen CJ, Hostetter LS, Nagy R, Derby RE, Slee AE, Arslan A, Auyong DB. Continuous ultrasound-guided adductor canal block for total knee arthroplasty: a randomized, double-blind trial. Anesth Analg. 2014 Jun;118(6):1370-7. doi: 10.1213/ANE.0000000000000197.

    PMID: 24842182BACKGROUND
  • Warman P, Nicholls B. Ultrasound-guided nerve blocks: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):313-26. doi: 10.1016/j.bpa.2009.02.004.

    PMID: 19862890BACKGROUND
  • Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273.

    PMID: 21148659BACKGROUND
  • Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.

    PMID: 25376972BACKGROUND
  • Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.

    PMID: 24121608BACKGROUND
  • Soffin EM, Gibbons MM, Ko CY, Kates SL, Wick EC, Cannesson M, Scott MJ, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Total Hip Arthroplasty. Anesth Analg. 2019 Mar;128(3):454-465. doi: 10.1213/ANE.0000000000003663.

    PMID: 30044289BACKGROUND
  • Risser A, Donovan D, Heintzman J, Page T. NSAID prescribing precautions. Am Fam Physician. 2009 Dec 15;80(12):1371-8.

    PMID: 20000300BACKGROUND
  • Schug SA, Zech D, Grond S. Adverse effects of systemic opioid analgesics. Drug Saf. 1992 May-Jun;7(3):200-13. doi: 10.2165/00002018-199207030-00005.

    PMID: 1354445BACKGROUND
  • Buvanendran A, Fiala J, Patel KA, Golden AD, Moric M, Kroin JS. The Incidence and Severity of Postoperative Pain following Inpatient Surgery. Pain Med. 2015 Dec;16(12):2277-83. doi: 10.1111/pme.12751. Epub 2015 Apr 27.

    PMID: 25917518BACKGROUND
  • 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: 34763273BACKGROUND
  • Gleicher Y, Dos Santos Fernandes H, Peacock S, Alekberli T, Di Grazia V, Estrellas R, Wolfstadt J, Matelski J, Siddiqui N. Comparison of migration rates between traditional and tunneled adductor canal block catheters: a randomized controlled trial. Reg Anesth Pain Med. 2024 Jun 3;49(6):423-428. doi: 10.1136/rapm-2023-104654.

  • Fujino T, Yoshida T, Kawagoe I, Hinotsume A, Hiratsuka T, Nakamoto T. Migration rate of proximal adductor canal block catheters placed parallel versus perpendicular to the nerve after total knee arthroplasty: a randomized controlled study. Reg Anesth Pain Med. 2023 Aug;48(8):420-424. doi: 10.1136/rapm-2022-104303. Epub 2023 Mar 28.

Study Officials

  • Hermann dos Santos Fernandes, MD, PhD

    University of Toronto

    STUDY CHAIR

Central Study Contacts

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
Dr

Study Record Dates

First Submitted

June 19, 2026

First Posted

July 2, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Anonymized REDCap data base , after conclusion of the study.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
At the conclusion of the study

Locations