SSSI Efficacy With iACB and PC-LIA in TKA Pain Management
- Conditions
- Peripheral Nerve BlocksPostoperative Pain Management in Total Knee Arthroplasty
- Registration Number
- NCT07191964
- Lead Sponsor
- Taipei Medical University WanFang Hospital
- 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.
- Detailed Description
This prospective, two-armed, triple-blinded, sham-controlled randomized controlled trial investigates the additive effect of Supra-Sartorial Subcutaneous Infiltration (SSSI) to intermittent adductor canal block (iACB) and posterior capsule local infiltration analgesia (PC-LIA) in multimodal pain management for total knee arthroplasty (TKA). SSSI is a peripheral nerve block technique the investigators devised as a simpler alternative to targeted anterior femoral cutaneous nerve (AFCN) block, which is technically more demanding and time-consuming. Based on the investigators' preliminary study (in publication) where SSSI combined with PC-LIA provided clinically meaningful analgesia in \~58% of patients, and drawing from previous studies on AFCN blocks, the trial compares: Arm 1 (all active SSSI + active iACB + active PC-LIA) versus Arm 2 (sham SSSI + active iACB + active PC-LIA). Adults (45-90 years) undergoing unilateral primary TKA (n=90, 45/arm) will be randomized 1:1, stratified by age, preoperative pain levels (in Numerical Rating Scale) and functional status (WOMAC Index or Knee Society Score). Interventions use 0.3% ropivacaine or saline shams, with SSSI and ACB catheterization performed in the post-anesthesia care unit by anesthesiologists and PC-LIA performed intraoperatively by surgeons. Primary outcome: Numerical Rating Scale pain scores at rest and during continuous passive motion at 9:00 PM on postoperative day (POD) 0, focusing on anteromedial knee pain. Secondary outcomes include daily pain scores, rescue ACB doses, additional opioid use, functional recovery (quadriceps strength, timed up and go \[TUG\] test), and complications over POD 0-3. With \~96% power for a 2-point NRS difference, this trial evaluates SSSI's role in enhancing motor-sparing analgesia.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain: NRS at rest/movement on postoperative day 0 (with a focus on the anteromedial aspect of knee) 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.
- Secondary Outcome Measures
Name Time Method 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. NRS pain scores (0-10) will be taken at rest/during TUG test on postoperative day 1 (9:00 AM, 9 :00 PM), POD 2 (9:00 AM, 9 :00 PM), and POD 3 (9:00 AM). Higher NRS pain scores indicate worse pain levels.
Complications From postoperative day 0 at 9:00 PM to postoperative day 3 at 9:00 AM. Complications such as falls, hematoma/oozing/infection at the catheterization site, catheter dislodgement, etc., will be recorded from postoperative day 0 to postoperative day 3.
Rescue ACB doses (0.3% ropivacaine, mg) From the time entering post-anesthesia care unit to postoperative day 3 at 9:00 AM Rescue ACB will be administered via catheter as needed outside of the scheduled doses (from postoperative day 0 at 9:00PM to postoperative day 3 at 9:00 AM, q12 hours).
Additional morphine doses (mg) From the time entering post-anesthesia care unit to postoperative day 3 at 9:00 AM Intravenous morphine as bolus or patient-controlled analgesia may be administered as needed if regional anesthesia fails to providing adequate analgesia (NRS pain \<4).
Functional: Quadriceps strength (dynamometer), TUG test From postoperative day 1 at 9:00 AM to postoperative day 3 at 9:00 AM. Quadriceps strength will be tested using a dynamometer together with TUG test from postoperative day 1 at 9:00 AM to postoperative day 3 at 9:00 AM, q24 hours