RCT: Suzetrigine vs Norco for Post-op Pain

Official title

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

Overview

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

• Drug Suzetrigine (SUZ)
  Used in the course of acute post-operative pain following oral and maxillofacial surgeries
• Drug Norco
  Its standard of care

Primary outcome measures

• Post-operative pain [Time frame: 72 hours post op]

Secondary outcome measures (1)

• Adverse drug effects [Time frame: 72 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• LSU Dental School — New Orleans

Publications

• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07195669 · LSU8322

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗