NCT07191964

Brief Summary

This prospective, triple-blinded, sham-controlled randomized trial evaluates the additive effect of Supra-Sartorial Subcutaneous Infiltration (SSSI) combined with intermittent adductor canal block (iACB) and posterior capsule local infiltration analgesia (PC-LIA) for pain management in total knee arthroplasty (TKA). SSSI, a simpler alternative to targeted anterior femoral cutaneous nerve (AFCN) block, is tested in 90 adults (45-90 years) randomized into two arms: sham SSSI + active iACB + PC-LIA versus all active interventions. Primary outcome is pain scores on postoperative day 0; secondary outcomes include daily pain trajectory, opioid use, functional recovery, and complications over days 0-3.

Trial Health

65
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Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jun 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 1, 2026

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 10, 2025

Last Update Submit

March 26, 2026

Conditions

Postoperative Pain Management in Total Knee ArthroplastyPeripheral Nerve Blocks

Outcome Measures

Primary Outcomes (1)

  • Pain: NRS at rest/movement on postoperative day 0 (with a focus on the anteromedial aspect of knee)

    NRS pain scores (0-10) at rest and during continuous passive motion will be taken on postoperative day 0 at 9:00 PM. Higher NRS pain scores indicate worse pain levels.

    at 9:00 PM on postoperative day 0

Secondary Outcomes (5)

  • Pain: NRS at rest/movement (anteromedial vs posterior aspect of knee) from postoperative day 1-3

    From postoperative day 1 at 9:00 AM to postoperative day 3 at 9:00 AM.

  • Rescue ACB doses (0.3% ropivacaine, mg)

    From the time entering post-anesthesia care unit to postoperative day 3 at 9:00 AM

  • Additional morphine doses (mg)

    From the time entering post-anesthesia care unit to postoperative day 3 at 9:00 AM

  • Functional: Quadriceps strength (dynamometer), TUG test

    From postoperative day 1 at 9:00 AM to postoperative day 3 at 9:00 AM.

  • Complications

    From postoperative day 0 at 9:00 PM to postoperative day 3 at 9:00 AM.

Other Outcomes (1)

  • Patient satisfaction

    At postoperative day 3 at 9:00 AM.

Study Arms (2)

SSSI + iACB + PC-LIA (all active)

ACTIVE COMPARATOR
Procedure: Supra-Sartorial Subcutaneous Infiltration (SSSI)Procedure: intermittent adductor canal block (iACB)Procedure: posterior capsule local infiltration analgesia (PC-LIA)

SSSI (sham) + iACB + PC-LIA

PLACEBO COMPARATOR
Procedure: Supra-Sartorial Subcutaneous Infiltration (SSSI)Procedure: intermittent adductor canal block (iACB)Procedure: posterior capsule local infiltration analgesia (PC-LIA)

Interventions

Supra-Sartorial Subcutaneous Infiltration (SSSI)PROCEDURE

20 mL ropivacaine or saline infiltrated lateral-to-medial subcutaneously above sartorius at femoral triangle apex using inject-as-you-advance technique, avoiding hyperechoic nerves.

SSSI (sham) + iACB + PC-LIASSSI + iACB + PC-LIA (all active)
intermittent adductor canal block (iACB)PROCEDURE

An adductor canal catheter is inserted proximal-to-distally over a distance of 6-10 cm at femoral triangle apex, with an initial bolus of 10 mL of 0.3% ropivacaine administered in PACU. The following doses start at 9:00 PM on the day of surgery and are repeated every 12 hours,

SSSI (sham) + iACB + PC-LIASSSI + iACB + PC-LIA (all active)
posterior capsule local infiltration analgesia (PC-LIA)PROCEDURE

PC-LIA consists of two 10 mL injections of 0.3% ropivacaine delivered intraoperatively to the posteromedial and posterolateral aspects of the posterior capsule before cementation. The target injection plane is the potential space between the posterior capsule and the popliteal artery.

SSSI (sham) + iACB + PC-LIASSSI + iACB + PC-LIA (all active)

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 45-90 undergoing unilateral primary TKA for osteoarthritis.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Able to provide informed consent and use NRS pain scales.
  • Surgery scheduled to start before noon to standardize spinal anesthesia recovery.

You may not qualify if:

  • Bilateral or revision TKA.
  • Contraindications to regional anesthesia (e.g., coagulopathy, infection at injection site).
  • Chronic opioid use (\>30 mg morphine equivalents/day) or preoperative NRS \>4.
  • Pre-existing neurological deficits in lower extremities or AFCN-related neuropathy.
  • Allergy to ropivacaine.
  • Pregnancy, breastfeeding, or cognitive impairment affecting assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Kampitak W, Tanavalee A, Tansatit T, Ngarmukos S, Songborassamee N, Vichainarong C. The analgesic efficacy of anterior femoral cutaneous nerve block in combination with femoral triangle block in total knee arthroplasty: a randomized controlled trial. Korean J Anesthesiol. 2021 Dec;74(6):496-505. doi: 10.4097/kja.21120. Epub 2021 Jun 29.

    PMID: 34182749BACKGROUND

  • Pivec C, Bodner G, Mayer JA, Brugger PC, Paraszti I, Moser V, Traxler H, Riegler G. Novel Demonstration of the Anterior Femoral Cutaneous Nerves using Ultrasound. Ultraschall Med. 2018 Feb 7. doi: 10.1055/s-0043-121628. Online ahead of print.

    PMID: 29415312BACKGROUND

  • Bjorn S, Nielsen TD, Jensen AE, Jessen C, Kolsen-Petersen JA, Moriggl B, Hoermann R, Bendtsen TF. The Anterior Branch of the Medial Femoral Cutaneous Nerve Innervates Cutaneous and Deep Surgical Incisions in Total Knee Arthroplasty. J Clin Med. 2024 May 31;13(11):3270. doi: 10.3390/jcm13113270.

    PMID: 38892981BACKGROUND

  • Bjorn S, Nielsen TD, Jensen AE, Jessen C, Kolsen-Petersen JA, Moriggl B, Hoermann R, Nyengaard JR, Bendtsen TF. The anterior branch of the medial femoral cutaneous nerve innervates the anterior knee: a randomized volunteer trial. Minerva Anestesiol. 2023 Jul-Aug;89(7-8):643-652. doi: 10.23736/S0375-9393.22.16910-5. Epub 2023 Feb 27.

    PMID: 36852567BACKGROUND

  • Bjorn S, Nielsen TD, Moriggl B, Hoermann R, Bendtsen TF. Anesthesia of the anterior femoral cutaneous nerves for total knee arthroplasty incision: randomized volunteer trial. Reg Anesth Pain Med. 2019 Dec 10:rapm-2019-100904. doi: 10.1136/rapm-2019-100904. Online ahead of print.

    PMID: 31826920BACKGROUND

Central Study Contacts

Shang-Ru Yeoh, MD, MSc

CONTACT

+886-987-850-411sr.yeoh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 25, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 1, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share