SSSI Efficacy With iACB and PC-LIA in TKA Pain Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain Management in Total Knee Arthroplasty Peripheral Nerve Blocks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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SSSI + iACB + PC-LIA (all active)

Group Type ACTIVE_COMPARATOR

Supra-Sartorial Subcutaneous Infiltration (SSSI)

Intervention Type 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.

intermittent adductor canal block (iACB)

Intervention Type 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,

posterior capsule local infiltration analgesia (PC-LIA)

Intervention Type 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-LIA

Group Type PLACEBO_COMPARATOR

Supra-Sartorial Subcutaneous Infiltration (SSSI)

Intervention Type 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.

intermittent adductor canal block (iACB)

Intervention Type 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,

posterior capsule local infiltration analgesia (PC-LIA)

Intervention Type 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.

Interventions

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Supra-Sartorial Subcutaneous Infiltration (SSSI)

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.

Intervention Type PROCEDURE

intermittent adductor canal block (iACB)

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,

Intervention Type PROCEDURE

posterior capsule local infiltration analgesia (PC-LIA)

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No