Pelvic Organ Prolapse (POP)Phase 4NCT07600697
Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
A Phase 4 study testing Suzetrigine, Opioid Analgesics (Tramadol or Oxycodone) and Scheduled Acetaminophen and Ibuprofen in people with Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), run by University of California, Los Angeles at 1 site in United States.
Trial summary
Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI), Postoperative Pain
- What is being tested?
- Suzetrigine, Opioid Analgesics (Tramadol or Oxycodone) and Scheduled Acetaminophen and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jul 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Undergoing elective transvaginal pelvic reconstructive surgery at UCLA with planned same-day discharge or 23-hour observation.
- Able to provide written informed consent.
Who cannot join
- Chronic opioid use.
- Liver failure.
- End-stage renal disease (ESRD).
- Chronic pain syndromes, including:
- Fibromyalgia Interstitial cystitis Chronic pelvic pain
- Contraindication to acetaminophen or ibuprofen.
- Use of strong CYP3A4 inhibitors within 7 days prior to surgery or anticipated need during the treatment period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
About this study
Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.
Read the detailed description
Suzetrigine has demonstrated analgesic efficacy comparable to hydrocodone/acetaminophen in Phase III trials and is FDA-approved for acute pain. This trial represents the first evaluation of a NaV1.8 inhibitor in pelvic reconstructive surgery. Participants will receive either suzetrigine or standard opioid-inclusive postoperative care according to a stepped-wedge randomization schedule. Pain scores, medication use, and adverse events will be collected at 48 hours, 1 week, and 6 weeks postoperatively.
- Being tested
- Suzetrigine, Opioid Analgesics (Tramadol or Oxycodone), Scheduled Acetaminophen and Ibuprofen
- Keywords
- Suzetrigine, NaV1.8 Inhibitor, Non-opioid analgesic, pelvic reconstructive surgery, transvaginal surgery, postoperative pain, opioid-sparing analgesia, multimodal pain management, pelvic organ prolapse, randomized clinical trial, stepped-wedge design, phase 4 trial
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Loading dose: 100 mg orally on the morning of surgery
Maintenance dose: 50 mg orally every 12 hours for 7 days
Co-administered medications: Scheduled acetaminophen and ibuprofen
Mechanism: Selective NaV1.8 sodium channel inhibitor acting on peripheral nociceptive neurons
Purpose: Opioid-sparing postoperative analgesia
Opioid Analgesics (Tramadol or Oxycodone)Drug
Tramadol: 50 mg orally every 4-6 hours as needed OR
Oxycodone: 5 mg orally every 4-6 hours as needed
Co-administered medications: Scheduled acetaminophen and ibuprofen
Purpose: Standard postoperative analgesia per institutional protocol
Scheduled Acetaminophen and IbuprofenDrug
Participants in both study arms will receive scheduled acetaminophen and ibuprofen as part of standard multimodal postoperative analgesia. These medications are administered routinely following transvaginal pelvic reconstructive surgery to reduce baseline pain, minimize opioid requirements, and support enhanced recovery.
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine-Based Regimen | Experimental | Participants receive suzetrigine as part of a multimodal postoperative analgesic regimen. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days, in combination with scheduled acetaminophen and ibuprofen. Receives: Drug: Suzetrigine; Drug: Scheduled Acetaminophen and Ibuprofen |
| Standard Opioid-Inclusive Analgesic Regimen | Active comparator | Participants receive standard postoperative pain management consisting of scheduled acetaminophen and ibuprofen, with opioid analgesics available as needed per routine clinical care. Receives: Drug: Opioid Analgesics (Tramadol or Oxycodone); Drug: Scheduled Acetaminophen and Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (0-10 NRS) at 48 hours postoperatively
Patient-reported postoperative pain intensity measured using the 0-10 Numerical Rating Scale (NRS).
Measured: 48 hours postoperatively
Secondary outcomes (10)
Pain Intensity at 1 Week
Patient-reported pain intensity using the 0-10 NRS.
Measured: 1 week after surgery
Time to Rescue Analgesia in PACU
Time from arrival in the post-anesthesia care unit to first administration of rescue analgesic medication.
Measured: During stay in post-anesthesia care unit, measured in hours up to 23 hours
Post-Discharge Opioid Use
Total opioid consumption after discharge, measured in morphine milligram equivalents (MME).
Measured: Postoperative days 0-7
Post-Discharge Gabapentin Use
Any gabapentin or pregabalin use after discharge.
Measured: Postoperative days 0-7
Constipation
Time to first bowel movement
Additional bowel regimen use
Measured: Up to 1 week postoperatively
Nausea and Vomiting
Incidence of postoperative nausea or vomiting reported by participants.
Measured: Up to 1 week postoperatively
Dizziness or Lightheadedness
Incidence of postoperative dizziness or lightheadedness.
Measured: Up to 1 week postoperatively
Time to Return to Driving
Number of days from surgery until the participant reports resuming driving.
Measured: Up to 6 weeks
Time to Return to Work
Number of days from surgery until the participant reports returning to work.
Measured: Up to 6 weeks
Postoperative Patient-Initiated Communication Burden
Number of patient-initiated messages, calls, or portal contacts related to postoperative pain or medication concerns.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (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 Pelvic Organ Prolapse (POP)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge randomized design
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Lenore Ackerman, University of California, Los Angeles
- Investigators
- A Lenore Ackeman, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600697
- Sponsor's protocol ID
- 26-0498
- Status last verified
- Sep 2026
- First submitted
- 11 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data (IPD). Due to the sensitive nature of postoperative clinical data and institutional policies regarding patient privacy, de-identified datasets will not be made available. Study findings will be disseminated through aggregate results posted on ClinicalTrials.gov and peer-reviewed publications.
Publications
Dong S, Zhong Y, Chu L, Li H, Tong X, Wang J. Age-stratified analysis of long-term outcomes of transvaginal mesh repair for treatment of pelvic organ prolapse. Int J Gynaecol Obstet. 2016 Oct;135(1):112-6. doi: 10.1016/j.ijgo.2016.03.031. Epub 2016 Jun 20.
PubMed 27392806Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007 Mar 24;369(9566):1027-38. doi: 10.1016/S0140-6736(07)60462-0.
PubMed 17382829Petrikovets A, Sheyn D, Sun HH, Chapman GC, Mahajan ST, Pollard RR, El-Nashar SA, Hijaz AK, Mangel J. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2019 Nov;221(5):511.e1-511.e10. doi: 10.1016/j.ajog.2019.06.002. Epub 2019 Jun 12.
PubMed 31201808Keam SJ. Suzetrigine: First Approval. Drugs. 2025 Jun;85(6):845-851. doi: 10.1007/s40265-025-02178-w. Epub 2025 May 5.
PubMed 40323340Ali MY, Antunes FTT, Huang S, Chen L, Zamponi GW. Pharmacological inhibition of NaV1.8 by suzetrigine reveals potent analgesic potential without tolerance development in mice. Mol Brain. 2025 Nov 13;18(1):86. doi: 10.1186/s13041-025-01253-3.
PubMed 41233910Stewart RG, Osorno T, Fujita A, Jo S, Ferraiuolo A, Carlin K, Bean BP. Modulation of human dorsal root ganglion neuron firing by the Nav1.8 inhibitor suzetrigine. Proc Natl Acad Sci U S A. 2025 Jun 3;122(22):e2503570122. doi: 10.1073/pnas.2503570122. Epub 2025 May 27.
PubMed 40424150
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT07600697
- Acronym / sponsor ID
- 26-0498
- Keywords
- Suzetrigine, NaV1.8 Inhibitor, Non-opioid analgesic, pelvic reconstructive surgery, transvaginal surgery, postoperative pain, opioid-sparing analgesia, multimodal pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 22 May 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.
Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.
Detailed description
Suzetrigine has demonstrated analgesic efficacy comparable to hydrocodone/acetaminophen in Phase III trials and is FDA-approved for acute pain. This trial represents the first evaluation of a NaV1.8 inhibitor in pelvic reconstructive surgery. Participants will receive either suzetrigine or standard opioid-inclusive postoperative care according to a stepped-wedge randomization schedule. Pain scores, medication use, and adverse events will be collected at 48 hours, 1 week, and 6 weeks postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Stepped-wedge randomized design
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine-Based Regimen | Experimental | Drug: Suzetrigine, Drug: Scheduled Acetaminophen and IbuprofenParticipants receive suzetrigine as part of a multimodal postoperative analgesic regimen. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days, in combination with scheduled acetaminophen and ibuprofen. |
| Standard Opioid-Inclusive Analgesic Regimen | Active comparator | Drug: Opioid Analgesics (Tramadol or Oxycodone), Drug: Scheduled Acetaminophen and IbuprofenParticipants receive standard postoperative pain management consisting of scheduled acetaminophen and ibuprofen, with opioid analgesics available as needed per routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Undergoing elective transvaginal pelvic reconstructive surgery at UCLA with planned same-day discharge or 23-hour observation.
- Able to provide written informed consent.
Key exclusion criteria (7 listed)
- Chronic opioid use.
- Liver failure.
- End-stage renal disease (ESRD).
- Chronic pain syndromes, including:
- Fibromyalgia Interstitial cystitis Chronic pelvic pain
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 |
|---|---|---|
| SuzetrigineLoading dose: 100 mg orally on the morning of surgery Maintenance dose: 50 mg orally every 12 hours for 7 days Co-administered medications: Scheduled acetaminophen and ibuprofen Mechanism: Selective NaV1.8 sodium channel inhibitor acting on peripheral nociceptive neurons Purpose: Opioid-sparing postoperative analgesia | Drug | Suzetrigine-Based Regimen |
| Opioid Analgesics (Tramadol or Oxycodone)Tramadol: 50 mg orally every 4-6 hours as needed OR Oxycodone: 5 mg orally every 4-6 hours as needed Co-administered medications: Scheduled acetaminophen and ibuprofen Purpose: Standard postoperative analgesia per institutional protocol | Drug | Standard Opioid-Inclusive Analgesic Regimen |
| Scheduled Acetaminophen and IbuprofenParticipants in both study arms will receive scheduled acetaminophen and ibuprofen as part of standard multimodal postoperative analgesia. These medications are administered routinely following transvaginal pelvic reconstructive surgery to reduce baseline pain, minimize opioid requirements, and support enhanced recovery. | Drug | Standard Opioid-Inclusive Analgesic Regimen, Suzetrigine-Based Regimen |
Primary outcome
Pain intensity (0-10 NRS) at 48 hours postoperatively
Time frame: 48 hours postoperatively
Patient-reported postoperative pain intensity measured using the 0-10 Numerical Rating Scale (NRS).
10 secondary outcomes
Pain Intensity at 1 Week
Time frame: 1 week after surgery
Time to Rescue Analgesia in PACU
Time frame: During stay in post-anesthesia care unit, measured in hours up to 23 hours
Post-Discharge Opioid Use
Time frame: Postoperative days 0-7
Post-Discharge Gabapentin Use
Time frame: Postoperative days 0-7
Constipation
Time frame: Up to 1 week postoperatively
Nausea and Vomiting
Time frame: Up to 1 week postoperatively
Dizziness or Lightheadedness
Time frame: Up to 1 week postoperatively
Time to Return to Driving
Time frame: Up to 6 weeks
Time to Return to Work
Time frame: Up to 6 weeks
Postoperative Patient-Initiated Communication Burden
Time frame: Up to 6 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 15 Sep 2026.
- Background: PubMed 27392806Dong S, Zhong Y, Chu L, Li H, Tong X, Wang J. Age-stratified analysis of long-term outcomes of transvaginal mesh repair for treatment of pelvic organ prolapse. Int J Gynaecol Obstet. 2016 Oct;135(1):112-6. doi: 10.1016/j.ijgo.2016.03.031. Epub 2016 Jun 20.
- Background: PubMed 17382829Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007 Mar 24;369(9566):1027-38. doi: 10.1016/S0140-6736(07)60462-0.
- Background: PubMed 31201808Petrikovets A, Sheyn D, Sun HH, Chapman GC, Mahajan ST, Pollard RR, El-Nashar SA, Hijaz AK, Mangel J. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2019 Nov;221(5):511.e1-511.e10. doi: 10.1016/j.ajog.2019.06.002. Epub 2019 Jun 12.
- Background: PubMed 40323340Keam SJ. Suzetrigine: First Approval. Drugs. 2025 Jun;85(6):845-851. doi: 10.1007/s40265-025-02178-w. Epub 2025 May 5.
- Background: PubMed 41233910Ali MY, Antunes FTT, Huang S, Chen L, Zamponi GW. Pharmacological inhibition of NaV1.8 by suzetrigine reveals potent analgesic potential without tolerance development in mice. Mol Brain. 2025 Nov 13;18(1):86. doi: 10.1186/s13041-025-01253-3.
- Background: PubMed 40424150Stewart RG, Osorno T, Fujita A, Jo S, Ferraiuolo A, Carlin K, Bean BP. Modulation of human dorsal root ganglion neuron firing by the Nav1.8 inhibitor suzetrigine. Proc Natl Acad Sci U S A. 2025 Jun 3;122(22):e2503570122. doi: 10.1073/pnas.2503570122. Epub 2025 May 27.
- Individual participant dataSharing planned: No. The investigators do not plan to share individual participant data (IPD). Due to the sensitive nature of postoperative clinical data and institutional policies regarding patient privacy, de-identified datasets will not be made available. Study findings will be disseminated through aggregate results posted on ClinicalTrials.gov and peer-reviewed publications.
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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.
A Lenore Ackeman, MD, PhD principal investigator
University of California, Los Angeles
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, Opioid Analgesics (Tramadol or Oxycodone) and Scheduled Acetaminophen and Ibuprofen in people with Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), run by University of California, Los Angeles 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 7 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 15 Sep 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?
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 A Lenore Ackerman, MD, PhD (310-794-0206, aackerman@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (0-10 NRS) at 48 hours postoperatively (time frame: 48 hours postoperatively). 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 NCT07600697, 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 15 Sep 2026.