RCT: Suzetrigine vs Norco for Post-op Pain

NCT07195669 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: LSU8322
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Control

Keywords

pain; analgesic; post-operative

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  Numeric 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)

  72 hours post op

Secondary Outcomes (1)

• Adverse drug effects

  72 hours

Study Arms (2)

Suzetrigine + Ibuprofen

EXPERIMENTAL

\- Group 1 will receive a 100-mg oral loading dose of Journavx (suzetrigine), followed by a 50-mg maintenance dose every 12 hours (the high-dose group) and ibuprofen 800 mg q8h for 72 hours after surgery (1).

Drug: Suzetrigine (SUZ)

Opioid + Ibuprofen

ACTIVE COMPARATOR

\- Group 2 will receive ibuprofen 800 mg x 15 tabs q8h scheduled and hydrocodone/acetaminophen 5/325 q8h PRN for 72 hours after surgery. Patients will be informed not to exceed 3g of acetaminophen or 3200 mg ibuprofen (1).

Drug: Norco

Interventions

Suzetrigine (SUZ) DRUG

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

Suzetrigine + Ibuprofen

Norco DRUG

Its standard of care

Opioid + Ibuprofen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacob Lensing: lead

Study Sites (1)

LSU Dental School

New Orleans, Louisiana, 70214, United States

Location

Related Publications (6)

• Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.

  PMID: 37530822 BACKGROUND

• Mutlu I, Abubaker AO, Laskin DM. Narcotic prescribing habits and other methods of pain control by oral and maxillofacial surgeons after impacted third molar removal. J Oral Maxillofac Surg. 2013 Sep;71(9):1500-3. doi: 10.1016/j.joms.2013.04.031.

  PMID: 23948362 BACKGROUND

• Mobini A, Mehra P, Chigurupati R. Postoperative Pain and Opioid Analgesic Requirements After Orthognathic Surgery. J Oral Maxillofac Surg. 2018 Nov;76(11):2285-2295. doi: 10.1016/j.joms.2018.05.014. Epub 2018 May 19.

  PMID: 29886112 BACKGROUND

• Sancho-Puchades M, Valmaseda-Castellon E, Berini-Aytes L, Gay-Escoda C. Quality of life following third molar removal under conscious sedation. Med Oral Patol Oral Cir Bucal. 2012 Nov 1;17(6):e994-9. doi: 10.4317/medoral.17677.

  PMID: 22926461 BACKGROUND

• Tuzuner AM, Ucok C, Kucukyavuz Z, Alkis N, Alanoglu Z. Preoperative diclofenac sodium and tramadol for pain relief after bimaxillary osteotomy. J Oral Maxillofac Surg. 2007 Dec;65(12):2453-8. doi: 10.1016/j.joms.2007.06.622.

  PMID: 18022468 BACKGROUND

• Park R, Mohiuddin M, Arellano R, Pogatzki-Zahn E, Klar G, Gilron I. Prevalence of postoperative pain after hospital discharge: systematic review and meta-analysis. Pain Rep. 2023 May 8;8(3):e1075. doi: 10.1097/PR9.0000000000001075. eCollection 2023 May-Jun.

  PMID: 37181639 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain

Interventions

oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacob Lensing, DDS

  LSUHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob N Lensing, DDS

CONTACT

641-780-0290; jlensi@lsuhsc.edu

James Vegryzn, DDS, MD

CONTACT

630-962-4605; jlensing96@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)