Post Operative PainPhase 4NCT07257133
A Study Of Opioid Avoidance In Surgery Through Integrating Suzetrigine
A Phase 4 study testing Suzetrigine in people with Post Operative Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
This prospective, single-arm feasibility study will evaluate postoperative pain control, opioid use, and early recovery outcomes in adult patients undergoing elective outpatient facial plastic surgery who receive suzetrigine as part of their standard postoperative analgesic regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Suzetrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to 1 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Adults (≥18 years) undergoing elective outpatient facial plastic surgery.
- Able to consent and comply with study procedures.
- Planned postoperative use of suzetrigine per provider discretion.
Who cannot join
- Age <18.
- Pregnant or breastfeeding.
- Women on hormonal birth control who decline suzetrigine-related counseling.
- Patients using strong CYP3A4 inhibitor medications (i.e. itraconazole, ketoconazole, clarithromycin, ritonavir, and grapefruit juice).
- Known allergy to suzetrigine.
- Vulnerable or protected research populations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Avoidance In Surgery Through Integrating Suzetrigine: Post-Operative Care Phase Pilot
This prospective, single-arm feasibility study will evaluate postoperative pain control, opioid use, and early recovery outcomes in adult patients undergoing elective outpatient facial plastic surgery who receive suzetrigine as part of their standard postoperative analgesic regimen.
Read the detailed description
Traditional postoperative pain management in facial plastic surgery often relies on opioid analgesics. While effective, their use is associated with adverse effects such as constipation, nausea, vomiting, sedation, respiratory depression, and dependency risk. In the context of the ongoing opioid misuse public health crisis, identifying effective non-opioid alternatives is crucial.
Suzetrigine is a first-in-class oral analgesic that selectively inhibits the voltage-gated sodium channel NaV1.8. These channels are selectively expressed within peripheral pain-sensing neurons and do not have a functional role within the central nervous system (CNS). Unlike opioids, suzetrigine does not cross the blood-brain barrier and avoids CNS side effects such as sedation, respiratory depression, and addiction potential.
In January 2025, the U.S. Food and Drug Administration (FDA) approved suzetrigine for the short-term treatment of moderate-to-severe acute pain in adults. Approval was supported by two Phase 3 randomized controlled trials in patients undergoing abdominoplasty (NCT05558410) and bunionectomy (NCT05553366), both standard models for acute postoperative pain. In these studies, suzetrigine demonstrated analgesic efficacy comparable to hydrocodone/acetaminophen, with a faster onset of meaningful pain relief than placebo and a favorable tolerability profile.
Despite this evidence, there is currently no data on the use of suzetrigine in facial plastic surgery. The integration of suzetrigine into postoperative pain management regimens for this population has the potential to reduce opioid prescription patterns and improve patient outcomes. This single-arm feasibility study aims to describe our early experience with suzetrigine and provide preliminary evidence to inform the feasibility and design of future prospective trials.
- Conditions
- Post Operative Pain
- Being tested
- Suzetrigine
- Keywords
- Facial plastic surgery
- 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
Patients will receive suzetrigine instead of the standard of care opioids.
The dosing schedule will be: a single oral loading dose of 100 mg suzetrigine, followed by 50 mg every 12 hours starting 12 hours after the first dose. Treatment will begin right after surgery and continue for up to 7 days.
All patients will also receive acetaminophen (650 mg every 6 hours) and celecoxib (200 mg every 24 hours) as part of the standard multimodal pain management regimen.
Patients experiencing breakthrough pain will be prescribed rescue opioid medication (oxycodone 5 mg every 6 hours as needed) and use will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine | Experimental | Patients will receive Suzetrigine in place of opioid medications for post-operative pain management. Receives: Drug: Suzetrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Number of opioid pills used during the first 7 postoperative days
Measured: 7 days post-operation
Number of patients with no rescue use
Total number of patients who do not use any rescue opioids postoperatively
Measured: 7 days post-operation
Secondary outcomes (1)
Pain intensity score
Pain intensity score during the first postoperative day will be measured by the 1 question Visual Analog Scale for pain. Patients will rank level of pain experienced on a 10 point Likert scale, with 0 = No pain and 10 = Worst pain imaginable.
Measured: 1 day post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start20 Oct 2025
- Primary completion1 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deanna C. Menapace, Mayo Clinic
- Investigators
- Deanna C. Menapace, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257133
- Sponsor's protocol ID
- 25-004867
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valencia-Sanchez BA, Colontonio MM, Menapace DC. Protocol for a prospective single-arm feasibility study of suzetrigine for postoperative pain management in outpatient facial plastic surgery. Pain Manag. 2026 May 19:1-6. doi: 10.1080/17581869.2026.2676101. Online ahead of print.
PubMed 42156226
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Avoidance In Surgery Through Integrating Suzetrigine: Post-Operative Care Phase Pilot
- ClinicalTrials.gov ID
- NCT07257133
- Acronym / sponsor ID
- 25-004867
- Conditions
- Post Operative Pain
- Keywords
- Facial plastic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 2 Dec 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 prospective, single-arm feasibility study will evaluate postoperative pain control, opioid use, and early recovery outcomes in adult patients undergoing elective outpatient facial plastic surgery who receive suzetrigine as part of their standard postoperative analgesic regimen.
Detailed description
Traditional postoperative pain management in facial plastic surgery often relies on opioid analgesics. While effective, their use is associated with adverse effects such as constipation, nausea, vomiting, sedation, respiratory depression, and dependency risk. In the context of the ongoing opioid misuse public health crisis, identifying effective non-opioid alternatives is crucial.
Suzetrigine is a first-in-class oral analgesic that selectively inhibits the voltage-gated sodium channel NaV1.8. These channels are selectively expressed within peripheral pain-sensing neurons and do not have a functional role within the central nervous system (CNS). Unlike opioids, suzetrigine does not cross the blood-brain barrier and avoids CNS side effects such as sedation, respiratory depression, and addiction potential.
In January 2025, the U.S. Food and Drug Administration (FDA) approved suzetrigine for the short-term treatment of moderate-to-severe acute pain in adults. Approval was supported by two Phase 3 randomized controlled trials in patients undergoing abdominoplasty (NCT05558410) and bunionectomy (NCT05553366), both standard models for acute postoperative pain. In these studies, suzetrigine demonstrated analgesic efficacy comparable to hydrocodone/acetaminophen, with a faster onset of meaningful pain relief than placebo and a favorable tolerability profile.
Despite this evidence, there is currently no data on the use of suzetrigine in facial plastic surgery. The integration of suzetrigine into postoperative pain management regimens for this population has the potential to reduce opioid prescription patterns and improve patient outcomes. This single-arm feasibility study aims to describe our early experience with suzetrigine and provide preliminary evidence to inform the feasibility and design of future prospective trials.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine | Experimental | Drug: SuzetriginePatients will receive Suzetrigine in place of opioid medications for post-operative pain management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) undergoing elective outpatient facial plastic surgery.
- Able to consent and comply with study procedures.
- Planned postoperative use of suzetrigine per provider discretion.
Key exclusion criteria (6 listed)
- Age <18.
- Pregnant or breastfeeding.
- Women on hormonal birth control who decline suzetrigine-related counseling.
- Patients using strong CYP3A4 inhibitor medications (i.e. itraconazole, ketoconazole, clarithromycin, ritonavir, and grapefruit juice).
- Known allergy to suzetrigine.
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 |
|---|---|---|
| SuzetriginePatients will receive suzetrigine instead of the standard of care opioids. The dosing schedule will be: a single oral loading dose of 100 mg suzetrigine, followed by 50 mg every 12 hours starting 12 hours after the first dose. Treatment will begin right after surgery and continue for up to 7 days. All patients will also receive acetaminophen (650 mg every 6 hours) and celecoxib (200 mg every 24 hours) as part of the standard multimodal pain management regimen. Patients experiencing breakthrough pain will be prescribed rescue opioid medication (oxycodone 5 mg every 6 hours as needed) and use will be recorded. | Drug | Suzetrigine |
Primary outcome
Total opioid consumption
Time frame: 7 days post-operation
Number of opioid pills used during the first 7 postoperative days
Number of patients with no rescue use
Time frame: 7 days post-operation
Total number of patients who do not use any rescue opioids postoperatively
1 secondary outcome
Pain intensity score
Time frame: 1 day post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 42156226Valencia-Sanchez BA, Colontonio MM, Menapace DC. Protocol for a prospective single-arm feasibility study of suzetrigine for postoperative pain management in outpatient facial plastic surgery. Pain Manag. 2026 May 19:1-6. doi: 10.1080/17581869.2026.2676101. 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. This study is not recruiting at the moment.
Deanna C. Menapace, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suzetrigine in people with Post Operative Pain, run by Mayo Clinic at 1 site in United States.
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 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: finished, as of the sponsor's last update on 1 May 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 United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption (time frame: 7 days post-operation). The study lists 2 primary outcomes in all. 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 NCT07257133, which also lists 1 linked publication.
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 May 2026.