Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT07195669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RCT: Suzetrigine vs Norco for Post-op Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C514822', 'term': 'oxycodone-acetaminophen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'statistician'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain', 'timeFrame': '72 hours post op', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Adverse drug effects', 'timeFrame': '72 hours', 'description': 'Any unwanted side effects of the medication such as: headaches, nausea, rash, itching, and/or muscle spasms'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'analgesic', 'post-operative'], 'conditions': ['Pain Control']}, 'referencesModule': {'references': [{'pmid': '37530822', 'type': 'BACKGROUND', 'citation': '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': '23948362', 'type': 'BACKGROUND', 'citation': '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': '29886112', 'type': 'BACKGROUND', 'citation': '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': '22926461', 'type': 'BACKGROUND', 'citation': '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': '18022468', 'type': 'BACKGROUND', 'citation': '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': '37181639', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.', 'detailedDescription': '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.\n\nOpioids 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.\n\nJournavx (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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Patients aged 18-45 years undergoing bimaxillary orthognathic surgery.\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT07195669', 'briefTitle': 'RCT: Suzetrigine vs Norco for Post-op Pain', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'Nonopioid Versus Opioid Management of Post-operative Pain Following Oral & Maxillofacial Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LSU8322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suzetrigine + Ibuprofen', 'description': '\\- 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).', 'interventionNames': ['Drug: Suzetrigine (SUZ)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opioid + Ibuprofen', 'description': '\\- 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).', 'interventionNames': ['Drug: Norco']}], 'interventions': [{'name': 'Suzetrigine (SUZ)', 'type': 'DRUG', 'description': 'Used in the course of acute post-operative pain following oral and maxillofacial surgeries', 'armGroupLabels': ['Suzetrigine + Ibuprofen']}, {'name': 'Norco', 'type': 'DRUG', 'description': 'Its standard of care', 'armGroupLabels': ['Opioid + Ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70214', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'contacts': [{'name': 'Jacob Lensing, DDS', 'role': 'CONTACT', 'email': 'jlensi@lsuhsc.edu', 'phone': '641-780-0290'}, {'name': 'James Vegrzyn, DDS, MD', 'role': 'CONTACT', 'email': 'jvergrz@lsuhsc.edu', 'phone': '630-962-4605'}, {'name': 'Jacob Lensing, dds', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LSU Dental School', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'centralContacts': [{'name': 'Jacob N Lensing, DDS', 'role': 'CONTACT', 'email': 'jlensi@lsuhsc.edu', 'phone': '641-780-0290'}, {'name': 'James Vegryzn, DDS, MD', 'role': 'CONTACT', 'email': 'jlensing96@gmail.com', 'phone': '630-962-4605'}], 'overallOfficials': [{'name': 'Jacob Lensing, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LSUHSC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacob Lensing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Jacob Lensing', 'investigatorAffiliation': 'Louisiana State University Health Sciences Center in New Orleans'}}}}