Efficacy of an AFCN Proxy Block in Post-TKA Multimodal Pain Management

NCT07191964 | Not Yet Recruiting

• 1 other identifier: N202511018
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluates the additive effect of Supra-Sartorial Subcutaneous Infiltration (SSSI) when performed in combination with intermittent adductor canal block (iACB) and posterior capsule local infiltration analgesia (PC-LIA) for pain management after total knee arthroplasty (TKA). SSSI, an easy-to-perform tentative proxy block to targeted anterior femoral cutaneous nerve (AFCN) block, is tested in 90 adults (45-90 years) randomized into two arms: active SSSI versus sham SSSI. Primary outcome is pain scores at rest and during movement on postoperative day 0; secondary outcomes include daily pain trajectory at rest and during movement, functional recovery scores, rescue analgesic doses over days 0-3, and quality of recovery assessment on day 4.

Conditions

Postoperative Pain Management in Total Knee Arthroplasty

Keywords

Anterior Femoral Cutaneous Nerve Block; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Pain: VAS at rest and during movement on postoperative day 0

  VAS pain scores at rest and during continuous passive motion will be taken on postoperative day 0 at 9 PM. Higher VAS pain scores indicate worse pain levels.

  at 9 PM on postoperative day 0

Secondary Outcomes (6)

• Pain: VAS at rest and during movement from postoperative day 1-4

  From postoperative day 1 at 6 AM to postoperative day 4 at 6 AM.

• Rescue ACB doses (0.3% ropivacaine, mg)

  From the time discharging from post-anesthesia care unit to postoperative day 4 at 6 AM

• Additional morphine doses (mg)

  From the time discharging from post-anesthesia care unit to postoperative day 4 at 6 AM

• Functional: TUG test

  From postoperative day 1 at 6 AM to postoperative day 4 at 6 AM.

• Functional: CPM maximal allowable angle

  From postoperative day 0 at 9 PM to day 3 at 6 PM.

Study Arms (2)

SSSI (active) + iACB and PC-LIA

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 and 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 subcutaneously from lateral to medial, superficial to vastus medialis and sartorius muscle, at femoral triangle apex using inject-as-you-advance technique, avoiding hyperechoic nerves.

SSSI (active) + iACB and PC-LIA; SSSI (sham) + iACB and PC-LIA

intermittent adductor canal block (iACB) PROCEDURE

A single-shot adductor canal block is first performed post-operatively with 20 mL 0.3% Ropivacaine at the level of femoral triangle apex before inserting a catheter into the canal. The following doses (20 mL each time) start at 9:00 PM on the day of surgery and are intermittently given every 12 hours until day 4.

SSSI (active) + iACB and PC-LIA; SSSI (sham) + iACB and PC-LIA

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 (active) + iACB and PC-LIA; SSSI (sham) + iACB and PC-LIA

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Municipal Wanfang Hospital

Taipei, 116, Taiwan

Location

Related Publications (6)

• Yeoh SR, Chang WC, Wang KL, Tai KY, Hsu FK, Chuang CW. Supra-Sartorial Subcutaneous Infiltration (SSSI) for Anterior Femoral Cutaneous Nerve Coverage in Total Knee Arthroplasty: A Preliminary Clinical Study. Biomedicines. 2025 Sep 27;13(10):2368. doi: 10.3390/biomedicines13102368.

  PMID: 41153655 BACKGROUND

• 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: 34182749 BACKGROUND

• 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: 29415312 BACKGROUND

• 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: 38892981 BACKGROUND

• 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: 36852567 BACKGROUND

• 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: 31826920 BACKGROUND

Central Study Contacts

Shang-Ru Yeoh, MD, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• 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: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)