Postoperative Pain Following Knee ArthroplastyPhase 3NCT07357376
Evaluating Suzetrigine for Pain Control Following TKA
A Phase 3 study testing Suzetrigine in people with Postoperative Pain Following Knee Arthroplasty, run by AdventHealth.
Trial summary
The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine works to treat pain after total knee replacement surgery in adults. It will also learn about the safety of suzetrigine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Following Knee Arthroplasty
- What is being tested?
- Suzetrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Aug 2026
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Scheduled for elective, unilateral primary total knee arthroplasty
- Able to tolerate oral medications after surgery
Who cannot join
- Revision or bilateral total knee arthroplasty
- American Society of Anesthesiologists (ASA) physical status classification greater than 3
- Severe renal impairment (estimated glomerular filtration rate less than 15 mL/min/1.73 m²)
- Severe hepatic impairment (Child-Pugh Class C)
- Chronic opioid use of 30 morphine milligram equivalents per day or greater for more than 3 months
- Pregnancy or breastfeeding
Show all 9Show fewer
- Seizure disorder or known hypersensitivity to suzetrigine
- Use of medications contraindicated with CYP3A metabolism
- Active gastrointestinal ulcer or bleeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating a Non-Opioid Analgesic Strategy for Enhanced Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial of Suzetrigine
The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine works to treat pain after total knee replacement surgery in adults. It will also learn about the safety of suzetrigine. The main questions it aims to answer are:
Does suzetrigine lower the amount of opioid pain medicine participants use after surgery?
Read more
Does suzetrigine have any effect on postoperative patient-reported outcomes, including pain scores, range of motion, length of stay, and KOOS/PROMIS surveys?
Researchers will compare suzetrigine to a placebo to see if suzetrigine works to treat pain after total knee replacement surgery.
Participants will:
Take suzetrigine or a placebo by mouth for 14 days after surgery
Receive standard pain care, including opioid pain medicine only if needed
Report their pain levels using short daily surveys
Attend routine follow-up visits after surgery
Read the detailed description
Post-operative pain management following total knee arthroplasty (TKA) continues to present significant challenges. Despite multimodal Enhanced Recovery After Surgery (ERAS) protocols, over 60% of patients still require opioid medications two weeks after surgery. Given the ongoing opioid epidemic, opioid prescribing is a priority for quality improvement in orthopaedic surgery. High opioid exposure is associated with constipation, nausea, increased risk of falls, hindered rehabilitation, and persistent opioid use. Furthermore, opioid use within the early postoperative period following TKA is associated with a dose-dependent increased risk of periprosthetic joint infection and venous thromboembolic events. With over 700,000 TKAs performed each year in the United States, these complications represent not only individual patient risks but also broader public health concerns.
Multimodal pain regimens consisting of alternative analgesics such as acetaminophen, NSAIDs, and gabapentinoids may only provide partial relief for patients, leaving opioids as the default choice for managing breakthrough pain, despite their undesirable side effect profile and addictive potential.[8] This ongoing challenge underscores the urgent need to identify safer and more effective pain management strategies.
Suzetrigine (Brand name: Journavx), a selective inhibitor of NaV1.7/NaV1.8 channels, has emerged as a promising candidate. Phase 3 clinical trials have shown that suzetrigine provides pain relief comparable to opioids, effectively reducing pain scores, with fewer adverse effects. Data from phase 2 bunionectomy studies further support its opioid-sparing capabilities. Unlike opioids, suzetrigine does not cause sedation, respiratory depression, or dependency. Its favorable pharmacokinetic properties, including renal-sparing metabolism and convenient oral twice-daily dosing, make it well-suited for integration into ERAS protocols.
The purpose of this randomized controlled trial is to assess whether suzetrigine can serve as an effective, opioid-sparing analgesic after TKA. If the results are successful, this could lead to expanded FDA labeling, wider adoption in orthopaedic practices, and a significant decrease in opioid prescriptions on a large scale.
- Being tested
- Suzetrigine, Placebo
- Keywords
- Total Knee Arthroplasty, Postoperative Pain, Journavx, Suzetrigine, Opioid, Enhanced Recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Suzetrigine is an oral, non-opioid pain medication that works by blocking specific sodium channels involved in pain signaling. In this study, participants assigned to the suzetrigine group will receive a 100 milligram oral dose in the preoperative area, immediately prior to undergoing the procedure, followed by 50 milligrams taken by mouth twice daily for 14 days after surgery. Suzetrigine will be given in addition to standard postoperative pain care, including acetaminophen, nonsteroidal anti-inflammatory drugs when appropriate, and opioid pain medication only if needed for breakthrough pain.
PlaceboDrug
The placebo is an oral tablet designed to look like the suzetrigine tablet but contains no active drug. In this study, participants assigned to the placebo group will receive a tablet in the preoperative area immediately prior to the procedure, followed by placebo tablets taken by mouth twice daily for 14 days after surgery. The placebo will be given in addition to standard postoperative pain care, including acetaminophen, nonsteroidal anti-inflammatory drugs when appropriate, and opioid pain medication only if needed for breakthrough pain.
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine/Journavx | Experimental | Not described Receives: Drug: Suzetrigine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Usage
MME of opioid usage
Measured: 2 weeks
Secondary outcomes (6)
Numeric Pain Rating Scale Scores
Pain will be measured using the Numeric Pain Rating Scale (NPRS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain. NPRS scores will be collected daily for the first 14 days after surgery and summarized over the 2-week postoperative period.
Measured: 2 Weeks
Range of Motion
Knee range of motion will be assessed using goniometric measurement of knee flexion, performed by a trained care provider during routine postoperative evaluations. Range of motion reflects the degree of knee movement achieved after surgery. Greater range of motion indicates better functional recovery. Measurements will be obtained at discharge and at the 2-week postoperative visit.
Measured: 2 Weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Pain-related interference with daily activities will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference questionnaire. This is a standardized patient-reported outcome measure that evaluates the extent to which pain interferes with physical, social, and emotional functioning. Higher scores indicate worse pain interference.
Measured: 2 Weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
Physical function will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire, a validated patient-reported measure of mobility and functional ability. Higher scores indicate better physical function.
Measured: 2 Weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee-related symptoms and function will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. This patient-reported outcome measure evaluates pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Higher scores indicate better knee-related outcomes.
Measured: 2 Weeks
Incidence of Treatment-Emergent Side Effects
The occurrence of treatment-emergent side effects will be assessed during the first 2 weeks after surgery. Side effects monitored include nausea, vomiting, constipation, dizziness, sedation, pruritus, headache, weakness, and worsened sleep. The outcome will be reported as the number of participants experiencing one or more side effects during the assessment period. A higher number of participants with side effects indicates worse tolerability.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain Following 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Hip and Knee Surgeons
- Responsible party
- Principal investigator, Teja Yeramosu, AdventHealth
- Investigators
- Ramakanth Yakkanti, MD, Principal investigator, Rothman Orthopaedics Florida at AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357376
- Sponsor's protocol ID
- AH-ORTHO-JOURNAVX-01
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data may not be shared outside the research team. The study includes sensitive health information collected under institutional review board approval, and participant consent does not include public data sharing. Data will be analyzed and reported in aggregate to protect participant privacy.
Publications
Hu S, Lyu D, Gao J. Suzetrigine: The first Nav1.8 inhibitor approved for the treatment of moderate to severe acute pain. Drug Discov Ther. 2025 Mar 6;19(1):80-82. doi: 10.5582/ddt.2025.01010. Epub 2025 Feb 27.
PubMed 40010720Hang Kong AY, Tan HS, Habib AS. VX-548 in the treatment of acute pain. Pain Manag. 2024 Sep;14(9):477-486. doi: 10.1080/17581869.2024.2421749. Epub 2024 Nov 18.
PubMed 39552600Hannon CP, Fillingham YA, Nam D, Courtney PM, Curtin BM, Vigdorchik JM, Buvanendran A, Hamilton WG, Della Valle CJ; AAHKS Anesthesia & Analgesia Clinical Practice Guideline Workgroup. Opioids in Total Joint Arthroplasty: The Clinical Practice Guidelines of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. J Arthroplasty. 2020 Oct;35(10):2709-2714. doi: 10.1016/j.arth.2020.05.034. Epub 2020 May 26. No abstract available.
PubMed 32571594Shichman I, Roof M, Askew N, Nherera L, Rozell JC, Seyler TM, Schwarzkopf R. Projections and Epidemiology of Primary Hip and Knee Arthroplasty in Medicare Patients to 2040-2060. JB JS Open Access. 2023 Feb 28;8(1):e22.00112. doi: 10.2106/JBJS.OA.22.00112. eCollection 2023 Jan-Mar.
PubMed 36864906Chung BC, Bouz GJ, Mayfield CK, Nakata H, Christ AB, Oakes DA, Lieberman JR, Heckmann ND. Dose-Dependent Early Postoperative Opioid Use Is Associated with Periprosthetic Joint Infection and Other Complications in Primary TJA. J Bone Joint Surg Am. 2021 Aug 18;103(16):1531-1542. doi: 10.2106/JBJS.21.00045.
PubMed 34043598Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.
PubMed 25911660Sabatino MJ, Kunkel ST, Ramkumar DB, Keeney BJ, Jevsevar DS. Excess Opioid Medication and Variation in Prescribing Patterns Following Common Orthopaedic Procedures. J Bone Joint Surg Am. 2018 Feb 7;100(3):180-188. doi: 10.2106/JBJS.17.00672.
PubMed 29406338Atwood K, Shackleford T, Lemons W, Eicher JL, Lindsey BA, Klein AE. Postdischarge Opioid Use after Total Hip and Total Knee Arthroplasty. Arthroplast Today. 2021 Jan 30;7:126-129. doi: 10.1016/j.artd.2020.12.021. eCollection 2021 Feb.
PubMed 33553537Dawson Z, Stanton SS, Roy S, Farjo R, Aslesen HA, Hallstrom BR, Bicket MC. Opioid Consumption After Discharge From Total Knee and Hip Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2024 Aug;39(8):2130-2136.e7. doi: 10.1016/j.arth.2024.01.063. Epub 2024 Feb 8.
PubMed 38336301Shah R, Kuo YF, Westra J, Lin YL, Raji MA. Opioid Use and Pain Control After Total Hip and Knee Arthroplasty in the US, 2014 to 2017. JAMA Netw Open. 2020 Jul 1;3(7):e2011972. doi: 10.1001/jamanetworkopen.2020.11972. No abstract available.
PubMed 32729917
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Non-Opioid Analgesic Strategy for Enhanced Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial of Suzetrigine
- ClinicalTrials.gov ID
- NCT07357376
- Acronym / sponsor ID
- AH-ORTHO-JOURNAVX-01
- Keywords
- Total Knee Arthroplasty, Postoperative Pain, Journavx, Suzetrigine, Opioid, Enhanced Recovery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- American Association of Hip and Knee Surgeons
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine works to treat pain after total knee replacement surgery in adults. It will also learn about the safety of suzetrigine. The main questions it aims to answer are:
Does suzetrigine lower the amount of opioid pain medicine participants use after surgery?
Does suzetrigine have any effect on postoperative patient-reported outcomes, including pain scores, range of motion, length of stay, and KOOS/PROMIS surveys?
Researchers will compare suzetrigine to a placebo to see if suzetrigine works to treat pain after total knee replacement surgery.
Participants will:
Take suzetrigine or a placebo by mouth for 14 days after surgery
Receive standard pain care, including opioid pain medicine only if needed
Report their pain levels using short daily surveys
Attend routine follow-up visits after surgery
Detailed description
Post-operative pain management following total knee arthroplasty (TKA) continues to present significant challenges. Despite multimodal Enhanced Recovery After Surgery (ERAS) protocols, over 60% of patients still require opioid medications two weeks after surgery. Given the ongoing opioid epidemic, opioid prescribing is a priority for quality improvement in orthopaedic surgery. High opioid exposure is associated with constipation, nausea, increased risk of falls, hindered rehabilitation, and persistent opioid use. Furthermore, opioid use within the early postoperative period following TKA is associated with a dose-dependent increased risk of periprosthetic joint infection and venous thromboembolic events. With over 700,000 TKAs performed each year in the United States, these complications represent not only individual patient risks but also broader public health concerns.
Multimodal pain regimens consisting of alternative analgesics such as acetaminophen, NSAIDs, and gabapentinoids may only provide partial relief for patients, leaving opioids as the default choice for managing breakthrough pain, despite their undesirable side effect profile and addictive potential.[8] This ongoing challenge underscores the urgent need to identify safer and more effective pain management strategies.
Suzetrigine (Brand name: Journavx), a selective inhibitor of NaV1.7/NaV1.8 channels, has emerged as a promising candidate. Phase 3 clinical trials have shown that suzetrigine provides pain relief comparable to opioids, effectively reducing pain scores, with fewer adverse effects. Data from phase 2 bunionectomy studies further support its opioid-sparing capabilities. Unlike opioids, suzetrigine does not cause sedation, respiratory depression, or dependency. Its favorable pharmacokinetic properties, including renal-sparing metabolism and convenient oral twice-daily dosing, make it well-suited for integration into ERAS protocols.
The purpose of this randomized controlled trial is to assess whether suzetrigine can serve as an effective, opioid-sparing analgesic after TKA. If the results are successful, this could lead to expanded FDA labeling, wider adoption in orthopaedic practices, and a significant decrease in opioid prescriptions on a large scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine/Journavx | Experimental | Drug: Suzetrigine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Scheduled for elective, unilateral primary total knee arthroplasty
- Able to tolerate oral medications after surgery
Key exclusion criteria (9 listed)
- Revision or bilateral total knee arthroplasty
- American Society of Anesthesiologists (ASA) physical status classification greater than 3
- Severe renal impairment (estimated glomerular filtration rate less than 15 mL/min/1.73 m²)
- Severe hepatic impairment (Child-Pugh Class C)
- Chronic opioid use of 30 morphine milligram equivalents per day or greater for more than 3 months
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 |
|---|---|---|
| SuzetrigineSuzetrigine is an oral, non-opioid pain medication that works by blocking specific sodium channels involved in pain signaling. In this study, participants assigned to the suzetrigine group will receive a 100 milligram oral dose in the preoperative area, immediately prior to undergoing the procedure, followed by 50 milligrams taken by mouth twice daily for 14 days after surgery. Suzetrigine will be given in addition to standard postoperative pain care, including acetaminophen, nonsteroidal anti-inflammatory drugs when appropriate, and opioid pain medication only if needed for breakthrough pain. | Drug | Suzetrigine/Journavx |
| PlaceboThe placebo is an oral tablet designed to look like the suzetrigine tablet but contains no active drug. In this study, participants assigned to the placebo group will receive a tablet in the preoperative area immediately prior to the procedure, followed by placebo tablets taken by mouth twice daily for 14 days after surgery. The placebo will be given in addition to standard postoperative pain care, including acetaminophen, nonsteroidal anti-inflammatory drugs when appropriate, and opioid pain medication only if needed for breakthrough pain. | Drug | Placebo |
Primary outcome
Opioid Usage
Time frame: 2 weeks
MME of opioid usage
6 secondary outcomes
Numeric Pain Rating Scale Scores
Time frame: 2 Weeks
Range of Motion
Time frame: 2 Weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Time frame: 2 Weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
Time frame: 2 Weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 2 Weeks
Incidence of Treatment-Emergent Side Effects
Time frame: 2 Weeks
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 22 Jan 2026.
- Background: PubMed 40010720Hu S, Lyu D, Gao J. Suzetrigine: The first Nav1.8 inhibitor approved for the treatment of moderate to severe acute pain. Drug Discov Ther. 2025 Mar 6;19(1):80-82. doi: 10.5582/ddt.2025.01010. Epub 2025 Feb 27.
- Background: PubMed 39552600Hang Kong AY, Tan HS, Habib AS. VX-548 in the treatment of acute pain. Pain Manag. 2024 Sep;14(9):477-486. doi: 10.1080/17581869.2024.2421749. Epub 2024 Nov 18.
- Background: PubMed 32571594Hannon CP, Fillingham YA, Nam D, Courtney PM, Curtin BM, Vigdorchik JM, Buvanendran A, Hamilton WG, Della Valle CJ; AAHKS Anesthesia & Analgesia Clinical Practice Guideline Workgroup. Opioids in Total Joint Arthroplasty: The Clinical Practice Guidelines of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. J Arthroplasty. 2020 Oct;35(10):2709-2714. doi: 10.1016/j.arth.2020.05.034. Epub 2020 May 26. No abstract available.
- Background: PubMed 36864906Shichman I, Roof M, Askew N, Nherera L, Rozell JC, Seyler TM, Schwarzkopf R. Projections and Epidemiology of Primary Hip and Knee Arthroplasty in Medicare Patients to 2040-2060. JB JS Open Access. 2023 Feb 28;8(1):e22.00112. doi: 10.2106/JBJS.OA.22.00112. eCollection 2023 Jan-Mar.
- Background: PubMed 34043598Chung BC, Bouz GJ, Mayfield CK, Nakata H, Christ AB, Oakes DA, Lieberman JR, Heckmann ND. Dose-Dependent Early Postoperative Opioid Use Is Associated with Periprosthetic Joint Infection and Other Complications in Primary TJA. J Bone Joint Surg Am. 2021 Aug 18;103(16):1531-1542. doi: 10.2106/JBJS.21.00045.
- Background: PubMed 25911660Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.
- Background: PubMed 29406338Sabatino MJ, Kunkel ST, Ramkumar DB, Keeney BJ, Jevsevar DS. Excess Opioid Medication and Variation in Prescribing Patterns Following Common Orthopaedic Procedures. J Bone Joint Surg Am. 2018 Feb 7;100(3):180-188. doi: 10.2106/JBJS.17.00672.
- Background: PubMed 33553537Atwood K, Shackleford T, Lemons W, Eicher JL, Lindsey BA, Klein AE. Postdischarge Opioid Use after Total Hip and Total Knee Arthroplasty. Arthroplast Today. 2021 Jan 30;7:126-129. doi: 10.1016/j.artd.2020.12.021. eCollection 2021 Feb.
- Background: PubMed 38336301Dawson Z, Stanton SS, Roy S, Farjo R, Aslesen HA, Hallstrom BR, Bicket MC. Opioid Consumption After Discharge From Total Knee and Hip Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2024 Aug;39(8):2130-2136.e7. doi: 10.1016/j.arth.2024.01.063. Epub 2024 Feb 8.
- Background: PubMed 32729917Shah R, Kuo YF, Westra J, Lin YL, Raji MA. Opioid Use and Pain Control After Total Hip and Knee Arthroplasty in the US, 2014 to 2017. JAMA Netw Open. 2020 Jul 1;3(7):e2011972. doi: 10.1001/jamanetworkopen.2020.11972. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data may not be shared outside the research team. The study includes sensitive health information collected under institutional review board approval, and participant consent does not include public data sharing. Data will be analyzed and reported in aggregate to protect participant privacy.
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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.
Ramakanth Yakkanti, MD principal investigator
Rothman Orthopaedics Florida at AdventHealth
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suzetrigine in people with Postoperative Pain Following Knee Arthroplasty, run by AdventHealth.
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 3 inclusion and 9 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ramakanth Yakkanti, MD (844-407-4070, ramakanth.yakkanti@rothmanortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Usage (time frame: 2 weeks). 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 NCT07357376, which also lists 10 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 22 Jan 2026.