Efficacy of an AFCN Proxy Block in Post-TKA Multimodal Pain Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-90
SponsorTaipei Medical University WanFang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Supra-Sartorial Subcutaneous Infiltration (SSSI)
Procedure/Surgery20 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.
intermittent adductor canal block (iACB)
Procedure/SurgeryA 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.
posterior capsule local infiltration analgesia (PC-LIA)
Procedure/SurgeryPC-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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: SSSI (active) + iACB and PC-LIAActive comparator 3 interventions
Group B: SSSI (sham) + iACB and PC-LIAPlacebo comparator 3 interventions
Trial outcomes
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.
Time frame
at 9 PM on postoperative day 0Secondary outcomes
1
Pain: VAS at rest and during movement from postoperative day 1-4
VAS pain scores will be taken at rest and during CPM and TUG test on postoperative day 1 (6 AM, 6 PM), POD 2 (6 AM, 6 PM), POD 3 (6 AM, 6 PM), and POD 4 (6 AM). Higher VAS pain scores indicate worse pain levels.
Time frame
From postoperative day 1 at 6 AM to postoperative day 4 at 6 AM.2
Rescue ACB doses (0.3% ropivacaine, mg)
Rescue ACB will be administered via catheter as needed outside of the scheduled doses (from postoperative day 0 at 9 PM to postoperative day 4 at 6 AM, q12 hours).
Time frame
From the time discharging from post-anesthesia care unit to postoperative day 4 at 6 AM3
Additional morphine doses (mg)
Intravenous morphine as bolus or patient-controlled analgesia may be administered as needed if regional anesthesia fails to provide adequate analgesia (VAS pain \<4).
Time frame
From the time discharging from post-anesthesia care unit to postoperative day 4 at 6 AM4
Functional: TUG test
Daily TUG test will be performed from postoperative day 1 at 6 AM to postoperative day 4 at 6 AM, q24 hours. TUG test is measuted in seconds, with higher values indicating poorer functional recovery.
Time frame
From postoperative day 1 at 6 AM to postoperative day 4 at 6 AM.Sponsors and contacts
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Source ClinicalTrials.gov
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