Suzetrigine Added to Multimodal Analgesia for Women Undergoing Minimally Invasive Hysterectomy

NCT07836010 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro00121017
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Pain

Keywords

Suzetrigine; Hysterectomy; Multimodal Analgesia

Outcome Measures

Primary Outcomes (1)

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

  Number of participants needing any opioids

  Up to 7 days after PACU discharge following surgery

Secondary Outcomes (6)

• Total post-surgical opioid consumption after PACU discharge following surgery

  Up to 7 days after PACU discharge following surgery

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

  Up to 7 days after PACU discharge following surgery

• Pain score on day 7

  Day 7 after surgery

• Duration of PACU stay

  PACU stay, up to approximately 3 hours

• Need for opioids in PACU

  PACU stay, up to approximately 3 hours

Other Outcomes (2)

• Opioid related side effects in the suzetrigine group

  Up to 7 days after PACU discharge following surgery

• Proportion of participants reporting good, very good, or excellent on a Patient Global Assessment (PGA) for pain control at 7 days after surgery.

  Day 7 after surgery

Study Arms (2)

Suzetrigine Group

EXPERIMENTAL

Suzetrigine added to standard multimodal analgesia

Drug: Suzetrigine

Control Group

NO INTERVENTION

Standard Multimodal analgesia (historical cohort)

Interventions

Suzetrigine DRUG

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

Also known as: Journavx

Suzetrigine Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Duke University: lead
• Vertex Pharmaceuticals Incorporated: collaborator

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ashraf Habib

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share