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.
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.
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- 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.
- Conditions
- Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| Suzetrigine Group | Experimental | Suzetrigine added to standard multimodal analgesia Receives: Drug: Suzetrigine |
| Control Group | No intervention | Standard Multimodal analgesia (historical cohort) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
Pain score on day 7
Verbal rating pain score (0=no pain, 10= worst possible pain)
Measured: Day 7 after surgery
Duration of PACU stay
Minutes of stay in PACU
Measured: PACU stay, up to approximately 3 hours
Need for opioids in PACU
Number of participants needing any opioids in PACU
Measured: PACU stay, up to approximately 3 hours
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.
- First posted23 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Responsible party
- Sponsor
- Investigators
- Ashraf Habib, Principal investigator, Duke University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Adding Suzetrigine to Multimodal Analgesia for Minimally Invasive Hysterectomy
- ClinicalTrials.gov ID
- NCT07836010
- Acronym / sponsor ID
- Pro00121017
- Conditions
- Postoperative Pain
- Keywords
- Suzetrigine, Hysterectomy, Multimodal Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Sep 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine Group | Experimental | Drug: SuzetrigineSuzetrigine added to standard multimodal analgesia |
| Control Group | No intervention | –Standard Multimodal analgesia (historical cohort) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥18 years presenting for a laparoscopic/robotic hysterectomy.
- ASA Classification I-III.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| SuzetrigineAlso: JournavxSuzetrigine is an oral non-opioid pain medication used to treat moderate-to-severe acute pain in adults. | Drug | Suzetrigine Group |
Primary outcome
Postoperative opioid use after Post-Anesthesia Care Unit (PACU) discharge following surgery
Time frame: Up to 7 days after PACU discharge following surgery
Number of participants needing any opioids
6 secondary outcomes
Total post-surgical opioid consumption after PACU discharge following surgery
Time frame: Up to 7 days after PACU discharge following surgery
Average pain score in the first week following PACU discharge after surgery
Time frame: Up to 7 days after PACU discharge following surgery
Pain score on day 7
Time frame: Day 7 after surgery
Duration of PACU stay
Time frame: PACU stay, up to approximately 3 hours
Need for opioids in PACU
Time frame: PACU stay, up to approximately 3 hours
Opioid consumption in PACU
Time frame: PACU stay, up to approximately 3 hours
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 23 Sep 2026.
- 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.
Ashraf Habib principal investigator
Duke University
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.