Postoperative Pain Management in Total Knee ArthroplastyNCT07191964
Efficacy of an AFCN Proxy Block in Post-TKA Multimodal Pain Management
A study testing Supra-Sartorial Subcutaneous Infiltration (SSSI), intermittent adductor canal block (iACB) and posterior capsule local infiltration analgesia (PC-LIA) in people with Postoperative Pain Management in Total Knee Arthroplasty, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Postoperative Pain Management in Total Knee Arthroplasty
- What is being tested?
- Supra-Sartorial Subcutaneous Infiltration (SSSI), intermittent adductor canal block (iACB) and posterior capsule local infiltration analgesia (PC-LIA)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Supra-Sartorial Subcutaneous Infiltration (SSSI), intermittent adductor canal block (iACB), posterior capsule local infiltration analgesia (PC-LIA)
- Keywords
- Anterior Femoral Cutaneous Nerve Block, Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supra-Sartorial Subcutaneous Infiltration (SSSI)Procedure or surgery
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.
intermittent adductor canal block (iACB)Procedure or surgery
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.
posterior capsule local infiltration analgesia (PC-LIA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| SSSI (active) + iACB and PC-LIA | Active comparator | Not described Receives: Procedure: Supra-Sartorial Subcutaneous Infiltration (SSSI); Procedure: intermittent adductor canal block (iACB); Procedure: posterior capsule local infiltration analgesia (PC-LIA) |
| SSSI (sham) + iACB and PC-LIA | Placebo comparator | Not described Receives: Procedure: Supra-Sartorial Subcutaneous Infiltration (SSSI); Procedure: intermittent adductor canal block (iACB); Procedure: posterior capsule local infiltration analgesia (PC-LIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 9 PM on postoperative day 0
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At postoperative day 4 at 6 AM.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain Management in Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191964
- Sponsor's protocol ID
- N202511018
- Status last verified
- May 2026
- First submitted
- 10 Sep 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeoh SR, Chang WC, Wang KL, Tai KY, Hsu FK, Chuang CW. Supra-Sartorial Subcutaneous Infiltration (SSSI) for Anterior Femoral Cutaneous Nerve Coverage in Total Knee Arthroplasty: A Preliminary Clinical Study. Biomedicines. 2025 Sep 27;13(10):2368. doi: 10.3390/biomedicines13102368.
PubMed 41153655Kampitak W, Tanavalee A, Tansatit T, Ngarmukos S, Songborassamee N, Vichainarong C. The analgesic efficacy of anterior femoral cutaneous nerve block in combination with femoral triangle block in total knee arthroplasty: a randomized controlled trial. Korean J Anesthesiol. 2021 Dec;74(6):496-505. doi: 10.4097/kja.21120. Epub 2021 Jun 29.
PubMed 34182749Pivec C, Bodner G, Mayer JA, Brugger PC, Paraszti I, Moser V, Traxler H, Riegler G. Novel Demonstration of the Anterior Femoral Cutaneous Nerves using Ultrasound. Ultraschall Med. 2018 Feb 7. doi: 10.1055/s-0043-121628. Online ahead of print.
PubMed 29415312Bjorn S, Nielsen TD, Jensen AE, Jessen C, Kolsen-Petersen JA, Moriggl B, Hoermann R, Bendtsen TF. The Anterior Branch of the Medial Femoral Cutaneous Nerve Innervates Cutaneous and Deep Surgical Incisions in Total Knee Arthroplasty. J Clin Med. 2024 May 31;13(11):3270. doi: 10.3390/jcm13113270.
PubMed 38892981Bjorn S, Nielsen TD, Jensen AE, Jessen C, Kolsen-Petersen JA, Moriggl B, Hoermann R, Nyengaard JR, Bendtsen TF. The anterior branch of the medial femoral cutaneous nerve innervates the anterior knee: a randomized volunteer trial. Minerva Anestesiol. 2023 Jul-Aug;89(7-8):643-652. doi: 10.23736/S0375-9393.22.16910-5. Epub 2023 Feb 27.
PubMed 36852567Bjorn S, Nielsen TD, Moriggl B, Hoermann R, Bendtsen TF. Anesthesia of the anterior femoral cutaneous nerves for total knee arthroplasty incision: randomized volunteer trial. Reg Anesth Pain Med. 2019 Dec 10:rapm-2019-100904. doi: 10.1136/rapm-2019-100904. Online ahead of print.
PubMed 31826920
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07191964
- Acronym / sponsor ID
- N202511018
- Keywords
- Anterior Femoral Cutaneous Nerve Block, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSSI (active) + iACB and PC-LIA | Active comparator | Procedure: Supra-Sartorial Subcutaneous Infiltration (SSSI), Procedure: intermittent adductor canal block (iACB), Procedure: posterior capsule local infiltration analgesia (PC-LIA) |
| SSSI (sham) + iACB and PC-LIA | Placebo comparator | Procedure: Supra-Sartorial Subcutaneous Infiltration (SSSI), Procedure: intermittent adductor canal block (iACB), Procedure: posterior capsule local infiltration analgesia (PC-LIA) |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supra-Sartorial Subcutaneous Infiltration (SSSI)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. | Procedure or surgery | SSSI (active) + iACB and PC-LIA, SSSI (sham) + iACB and PC-LIA |
| intermittent adductor canal block (iACB)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. | Procedure or surgery | SSSI (active) + iACB and PC-LIA, SSSI (sham) + iACB and PC-LIA |
| 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. | Procedure or surgery | SSSI (active) + iACB and PC-LIA, SSSI (sham) + iACB and PC-LIA |
Primary outcome
Pain: VAS at rest and during movement on postoperative day 0
Time frame: 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.
6 secondary outcomes
Pain: VAS at rest and during movement from postoperative day 1-4
Time frame: From postoperative day 1 at 6 AM to postoperative day 4 at 6 AM.
Rescue ACB doses (0.3% ropivacaine, mg)
Time frame: From the time discharging from post-anesthesia care unit to postoperative day 4 at 6 AM
Additional morphine doses (mg)
Time frame: From the time discharging from post-anesthesia care unit to postoperative day 4 at 6 AM
Functional: TUG test
Time frame: From postoperative day 1 at 6 AM to postoperative day 4 at 6 AM.
Functional: CPM maximal allowable angle
Time frame: From postoperative day 0 at 9 PM to day 3 at 6 PM.
Quality of Recovery
Time frame: At postoperative day 4 at 6 AM.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 41153655Yeoh SR, Chang WC, Wang KL, Tai KY, Hsu FK, Chuang CW. Supra-Sartorial Subcutaneous Infiltration (SSSI) for Anterior Femoral Cutaneous Nerve Coverage in Total Knee Arthroplasty: A Preliminary Clinical Study. Biomedicines. 2025 Sep 27;13(10):2368. doi: 10.3390/biomedicines13102368.
- Background: PubMed 34182749Kampitak W, Tanavalee A, Tansatit T, Ngarmukos S, Songborassamee N, Vichainarong C. The analgesic efficacy of anterior femoral cutaneous nerve block in combination with femoral triangle block in total knee arthroplasty: a randomized controlled trial. Korean J Anesthesiol. 2021 Dec;74(6):496-505. doi: 10.4097/kja.21120. Epub 2021 Jun 29.
- Background: PubMed 29415312Pivec C, Bodner G, Mayer JA, Brugger PC, Paraszti I, Moser V, Traxler H, Riegler G. Novel Demonstration of the Anterior Femoral Cutaneous Nerves using Ultrasound. Ultraschall Med. 2018 Feb 7. doi: 10.1055/s-0043-121628. Online ahead of print.
- Background: PubMed 38892981Bjorn S, Nielsen TD, Jensen AE, Jessen C, Kolsen-Petersen JA, Moriggl B, Hoermann R, Bendtsen TF. The Anterior Branch of the Medial Femoral Cutaneous Nerve Innervates Cutaneous and Deep Surgical Incisions in Total Knee Arthroplasty. J Clin Med. 2024 May 31;13(11):3270. doi: 10.3390/jcm13113270.
- Background: PubMed 36852567Bjorn S, Nielsen TD, Jensen AE, Jessen C, Kolsen-Petersen JA, Moriggl B, Hoermann R, Nyengaard JR, Bendtsen TF. The anterior branch of the medial femoral cutaneous nerve innervates the anterior knee: a randomized volunteer trial. Minerva Anestesiol. 2023 Jul-Aug;89(7-8):643-652. doi: 10.23736/S0375-9393.22.16910-5. Epub 2023 Feb 27.
- Background: PubMed 31826920Bjorn S, Nielsen TD, Moriggl B, Hoermann R, Bendtsen TF. Anesthesia of the anterior femoral cutaneous nerves for total knee arthroplasty incision: randomized volunteer trial. Reg Anesth Pain Med. 2019 Dec 10:rapm-2019-100904. doi: 10.1136/rapm-2019-100904. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supra-Sartorial Subcutaneous Infiltration (SSSI), intermittent adductor canal block (iACB) and posterior capsule local infiltration analgesia (PC-LIA) in people with Postoperative Pain Management in Total Knee Arthroplasty, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shang-Ru Yeoh, MD, MSc (+886-987-850-411, sr.yeoh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: VAS at rest and during movement on postoperative day 0 (time frame: at 9 PM on postoperative day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07191964, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.