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Postoperative PainPhase 4NCT07836010

Suzetrigine Added to Multimodal Analgesia for Women Undergoing Minimally Invasive Hysterectomy

A Phase 4 study testing Suzetrigine in people with Postoperative Pain, run by Duke University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study will assess the analgesic efficacy of suzetrigine as part of a multimodal analgesic regimen in women undergoing laparoscopic or robotic hysterectomy. Outcomes will be compared with matched historical controls receiving the current ERAS regimen without suzetrigine. Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Postoperative 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
123 participants
Where
No sites listed yet
Study dates
Nov 2026to Feb 2028
Phase
Phase 4
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 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≥18 years presenting for a laparoscopic/robotic hysterectomy.
  • ASA Classification I-III.

Who cannot join

  • Chronic pain or chronic opioid therapy.
  • Allergy or contraindication to any component of the multimodal analgesic regimen.
  • Need to convert to an open procedure.
  • Subjects with severe hepatic or renal impairment and those receiving CYP3A inhibitors.
  • Inability to communicate pain scores or need for analgesics.
  • Suspected or known addiction to or abuse of illicit drugs, prescription medicine(s) or alcohol within the past 2 years.
Show all 9Show fewer
  • Psychiatric disorders that, in the opinion of the investigator, may interfere with study assessments or compliance.
  • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
  • Pregnancy.

About this study

Official title: The Impact of Adding Suzetrigine to Multimodal Analgesia for Minimally Invasive Hysterectomy

This study will assess the analgesic efficacy of suzetrigine as part of a multimodal analgesic regimen in women undergoing laparoscopic or robotic hysterectomy. Outcomes will be compared with matched historical controls receiving the current ERAS regimen without suzetrigine.

Read the detailed description

This will be a matched cohort study with a prospective and a retrospective component. Women undergoing laparoscopic/robotic hysterectomy with our ERAS protocol will be approached to participate in the prospective open label component of the study. In the preoperative holding area, patients will be asked about their preoperative anxiety and expectations for postoperative pain. Preoperative patient-reported anxiety will be assessed by asking the question: "On a scale from 1 to 100, how anxious are you regarding your upcoming surgery?" Postoperative anticipated opioid need will be measured by asking, "Do you anticipate requiring below average, average, or above average amount of pain medication following surgery?". Preoperatively, patients will receive the first dose of suzetrigine (100 mg) approximately 1 hour prior to surgery. Midazolam can be used for anxiolysis as needed. Intraoperatively, patients will receive the usual intraoperative ERAS analgesic regimen used at Duke university typically incorporating intraoperative opioids (typically fentanyl and hydromorphone), intraoperative IV acetaminophen 1000 mg and IV ketorolac 15 mg. In PACU, IV fentanyl will be allowed for analgesia as per standard practice. Postoperative multimodal analgesia will incorporate scheduled acetaminophen, ibuprofen and suzetrigine (50 mg q12h, oral) around the clock. Oral oxycodone will be used for rescue as required. Patients will be encouraged to wait at least 60 minutes after taking a dose of acetaminophen and ibuprofen before use of the opioid rescue. Patients will be contacted daily to collect data about verbal rating pain scores (0= no pain, 10= worst possible pain), opioid consumption and any adverse events. In addition, on day 7, additional information will be collected about patient global assessment of pain control (poor, fair, good, very good, excellent).

Cases will be matched in a 1:2 ratio by age, race, insurance status, duration of surgery, preoperative anxiety and anticipated need for analgesia with historical controls who received postoperative analgesia using our current multimodal analgesic regimen. The historical controls will be identified from a database of patients who underwent minimally invasive hysterectomy with documented end points that the investigators are using in this study. Those patients also have information documented that was collected prospectively about anxiety and anticipated analgesic needs, factors that have been shown to be associated with postoperative opioid consumption.

Being tested
Suzetrigine
Keywords
Suzetrigine, Hysterectomy, Multimodal Analgesia
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

    Also called Journavx

    Suzetrigine is an oral non-opioid pain medication used to treat moderate-to-severe acute pain in adults.

Study groups in NCT07836010
Study groupRoleWhat they receive
Suzetrigine GroupExperimentalSuzetrigine added to standard multimodal analgesia
Receives: Drug: Suzetrigine
Control GroupNo interventionStandard Multimodal analgesia (historical cohort)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative opioid use after Post-Anesthesia Care Unit (PACU) discharge following surgery

    Number of participants needing any opioids

    Measured: Up to 7 days after PACU discharge following surgery

Secondary outcomes (6)
  1. Total post-surgical opioid consumption after PACU discharge following surgery

    Total opioid consumption in mg

    Measured: Up to 7 days after PACU discharge following surgery

  2. Average pain score in the first week following PACU discharge after surgery

    Average verbal rating pain score

    Measured: Up to 7 days after PACU discharge following surgery

  3. Pain score on day 7

    Verbal rating pain score (0=no pain, 10= worst possible pain)

    Measured: Day 7 after surgery

  4. Duration of PACU stay

    Minutes of stay in PACU

    Measured: PACU stay, up to approximately 3 hours

  5. Need for opioids in PACU

    Number of participants needing any opioids in PACU

    Measured: PACU stay, up to approximately 3 hours

  6. Opioid consumption in PACU

    Total opioid consumption in mg morphine equivalents

    Measured: PACU stay, up to approximately 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
123 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07836010
Sponsor's protocol ID
Pro00121017
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
23 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Suzetrigine in people with Postoperative Pain, run by Duke University.

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 2 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 23 Sep 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. 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?

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?

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?

Postoperative opioid use after Post-Anesthesia Care Unit (PACU) discharge following surgery (time frame: Up to 7 days after PACU discharge following surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Sep 2026.

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