Purpose of this Study
We are doing this study to find out if an investigational drug called suzetrigine (the study drug) is a safe and effective option to help people who have acute postoperative pain.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have a body mass index (BMI) between 18 and 40
- Are scheduled for certain laparoscopic or arthroscopic surgeries at Duke
- Are not allergic to opioid medications or non-steroidal anti-inflammatory drugs (NSAIDs)
- Have never taken suzetrigine previously
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will:
- Start taking the study drug before your scheduled surgery and continue to take it for at least 14 days after your surgery or until your pain goes away (whichever comes first)
- Take acetaminophen and ibuprofen in addition to the study drug for up to 14 days after surgery or as long as pain continues
- Fill out surveys
- Return to our clinic for about 3 follow-up visits after your surgery
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Laparoscopic Procedures of the Intraperitoneal or Retroperitoneal Cavities or Arthroscopic Orthopedic Procedures
Study Website
Principal Investigator
Ashraf
Habib
Protocol Number
PRO00117274
NCT ID
NCT06887959
Phase
IV
Enrollment Status
Open to Enrollment