An interventional study of Supra-Sartorial Subcutaneous Infiltration (SSSI) and intermittent adductor canal block (iACB) in Postoperative Pain Management in Total Knee Arthroplasty, sponsored by Taipei Medical University WanFang Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Taipei Medical University WanFang Hospital · Not applicable, Interventional, and Treatment
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 90 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Taipei Medical University WanFang Hospital is the lead sponsor of 201 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Supra-Sartorial Subcutaneous Infiltration (SSSI) · Procedure: intermittent adductor canal block (iACB) · Procedure: posterior capsule local infiltration analgesia (PC-LIA)
Procedure: Supra-Sartorial Subcutaneous Infiltration (SSSI) · Procedure: intermittent adductor canal block (iACB) · Procedure: posterior capsule local infiltration analgesia (PC-LIA)
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.
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.
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.
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 0
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.
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 AM
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 AM
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.
Functional: CPM maximal allowable angle
CPM maximal allowable angle will be increased q24 hours according to patient's tolerance from day 0 at 9 PM to day 3 at 6 PM. CPM angle is measured in degree, with higher values indicating better postoperative recovery.
Time frame: From postoperative day 0 at 9 PM to day 3 at 6 PM.
Quality of Recovery
Quality of Recovery-15 (QoE-15) scores will be taken on postoperative day 4 at 6 AM. Value range 0-150, with higher scores indicating better recovery.
Time frame: At postoperative day 4 at 6 AM.
Plan to share: No
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