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临床试验/NCT07191964
NCT07191964尚未招募不适用

Efficacy Assessment of Supra-Sartorial Subcutaneous Infiltration (SSSI) as an Anterior Femoral Cutaneous Nerve Proxy Block in the Multimodal Pain Management After Total Knee Arthroplasty: A Randomized Controlled Trial

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Pain: VAS at rest and during movement on postoperative day 0

研究概览

简要总结

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.

详细描述

This prospective, double-blinded, sham-controlled randomized controlled trial investigates the additive analgesic effect of Supra-Sartorial Subcutaneous Infiltration (SSSI) when combined with intermittent adductor canal block (iACB) and posterior capsule local infiltration analgesia (PC-LIA) following total knee arthroplasty (TKA). The SSSI technique was developed as a simplified, practical alternative to the technically demanding targeted anterior femoral cutaneous nerve (AFCN) block. Drawing on preliminary data where SSSI provided clinically meaningful analgesia in approximately 58% of patients when paired with PC-LIA, this trial evaluates the role of SSSI in enhancing motor-sparing analgesia within a multimodal framework. The study will enroll 90 adults between the ages of 45 and 90 undergoing unilateral primary TKA. Participants will be randomized 1:1 into two groups of 45, with stratification based on gender and baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. All active interventions utilize 0.3% ropivacaine, while the control arm utilizes saline shams for the SSSI component. The SSSI and iACB catheterizations are performed by anesthesiologists in the post-anesthesia care unit, whereas the PC-LIA is administered intraoperatively by the surgical team. Patients in the active group receive active SSSI, active iACB, and active PC-LIA, while those in the sham group receive a saline SSSI alongside active iACB and active PC-LIA. The primary outcome is defined as Visual Analog Scale (VAS) pain scores at rest and during movement at 9:00 PM on postoperative day 0. Secondary outcomes include daily VAS pain scores at rest and during functional assessments such as continuous passive motion (CPM) and the timed up-and-go (TUG) test through postoperative day 1-4. Additionally, the trial monitors the maximal allowable degree of CPM, TUG test performance, cumulative rescue analgesic doses over the first 4 postoperative days, and Quality of Recovery-15 (QoR-15) scores on postoperative day 4. With approximately 96% power to detect a 2-point difference in pain scores, the trial aims to determine if SSSI significantly improves postoperative analgesia without compromising motor function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
45 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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 >
  • Pre-existing neurological deficits in lower extremities or AFCN-related neuropathy.
  • Allergy to ropivacaine.
  • Pregnancy, breastfeeding, or cognitive impairment affecting assessments.

结局指标

主要结局

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

时间窗: at 9 PM 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.

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

时间窗: at 9:00 PM on postoperative day 0

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.

次要结局

  • 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.)
  • Quality of Recovery(At postoperative day 4 at 6 AM.)
  • 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.)
  • Complications(From postoperative day 0 at 9:00 PM 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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