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RCT: Suzetrigine vs Norco for Post-op Pain

Nonopioid Versus Opioid Management of Post-operative Pain Following Oral & Maxillofacial Surgery: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07195669
Enrollment
76
Registered
2025-09-29
Start date
2025-10-01
Completion date
2026-01-30
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Control

Keywords

pain, analgesic, post-operative

Brief summary

Journavx (suzetrigine) is a novel non-opioid analgesic that is FDA approved for acute pain management and may offer a promising alternative for managing postoperative pain. Suzetrigine is selective inhibitor of the sodium channel NaV1.8, for managing acute pain. NaV1.8, a sodium channel, plays a key role in transmitting pain signals. Importantly, this channel is minimally expressed in the brain, enabling effective pain control without the potential central nervous system side effects of respiratory depression and addiction associated with opioids. Clinical trials have shown Journavx to be effective in managing moderate to severe post-operative pain equal to that of opiates. This study aims to further evaluate the efficacy and safety of Journavx in managing post-operative pain after third molar removal and orthognathic surgery. Participants in this study should be aged 18-45 without significant autoimmune diseases, chronic kidney disease, liver disease, chronic pain disorder including temporomandibular joint disorder, bleeding disorders, pregnant or nursing, undergoing either extraction of both lower third molars or orthognathic surgery of both the maxilla and mandible.

Detailed description

Every year millions of oral and maxillofacial surgical procedures are performed globally, with patients frequently experiencing significant postoperative pain that can persist long after hospital discharge1. One of the most frequent outpatient procedures performed by oral surgeons is third molar extraction, with an estimated 10 million such procedures performed annually in the United States alone2. Orthognathic surgery, another common procedure, has been reported to have the highest postoperative pain scores compared to other oral and maxillofacial procedures3. Inadequate pain control in this critical period can lead to impaired function, slower healing, and may be a factor in prolonged pain in the subacute setting4. Despite the critical importance of effective postoperative pain control to patient recovery, the optimal analgesic approach remains a topic of debate, with both opioid and non-opioid medications utilized in clinical practice5,6. Opioids have long played a central role in managing postoperative pain in oral surgery7. The risks associated with opioid use are well-documented7,8. Addiction and misuse are the most widely discussed opioid side effects in the public. However, more common side effects, such as nausea, vomiting, constipation, respiratory depression, and sedation, can have a profound effect on morbidity. Furthermore, there is a growing body of evidence suggesting that the overprescription of opioids following common procedures like wisdom tooth extraction contributes to the larger opioid epidemic8. These risks underscore the need for alternative pain management strategies that minimize or eliminate the need for opioids. Journavx (suzetrigine) is a novel non-opioid analgesic that offers a promising alternative for managing postoperative pain9,10. Suzetrigine is selective inhibitor of the sodium channel NaV1.8, for managing acute pain. NaV1.8, a sodium channel subtype found primarily in peripheral nerves and dorsal root ganglia, plays a key role in transmitting nociceptive signals. Importantly, this channel is minimally expressed in the brain, enabling selective blockade to provide targeted, effective analgesia without the potential central nervous system side effects of respiratory depression and addiction associated with opioids11. Clinical trials have shown Journavx to be effective in managing moderate to severe post-operative pain equal to that of opiates11. This study aims to further evaluate the efficacy and safety of Journavx in managing post-operative pain after third molar removal and orthognathic surgery.

Interventions

Used in the course of acute post-operative pain following oral and maxillofacial surgeries

DRUGNorco

Its standard of care

Sponsors

Jacob Lensing
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

statistician

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 18-45 years requiring extraction of impacted mandibular bilateral third molar teeth, uncomplicated mesioangular impacted teeth, or vertical impaction of unerupted and impacted mandibular third molars. * Patients aged 18-45 years undergoing bimaxillary orthognathic surgery.

Exclusion criteria

* Pregnant or nursing, history of prior opioid abuse, have history of temporomandibular dysfunction or local myofascial pain disorder preoperatively, with history of congenital syndrome requiring previous surgeries, orthognathic revisions, have a bleeding disorder, cannot receive instruction in English, are currently utilizing analgesics for another painful condition

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pain72 hours post opNumeric Pain Rating Scale (NPRS, a numeric version of a visual-analogue scale; scores range from 0 to 10, with higher scores indicating greater pain) at 8, 16, 24, 36, 48, 72 hours following surgery (6 time points)

Secondary

MeasureTime frameDescription
Adverse drug effects72 hoursAny unwanted side effects of the medication such as: headaches, nausea, rash, itching, and/or muscle spasms

Countries

United States

Contacts

Primary ContactJacob N Lensing, DDS
jlensi@lsuhsc.edu641-780-0290
Backup ContactJames Vegryzn, DDS, MD
jlensing96@gmail.com630-962-4605

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026