Non-Opioid Postoperative Pain Management in Skin Cancer Surgery: A Randomized Trial of Suzetrigine Versus Standard Analgesia in Minnesota
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 230
- 试验地点
- 3
- 主要终点
- Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 24 Hours
研究概览
简要总结
This randomized clinical trial will compare suzetrigine with standard analgesia for postoperative pain management after skin cancer surgery.
Adults undergoing Mohs micrographic surgery or wide local excision for cutaneous malignancy or a skin-cancer precursor lesion of the head and neck will be randomized to suzetrigine monotherapy or scheduled acetaminophen plus ibuprofen for 72 hours after surgery. The study uses a double-blind, double-dummy design, and breakthrough oxycodone may be prescribed in either arm on request after same-day clinical assessment.
The primary objective is to determine whether suzetrigine controls acute postoperative pain as well as scheduled acetaminophen plus ibuprofen during the first 24 hours after the first dose. Secondary outcomes include rescue opioid consumption, pain through 48 and 72 hours, satisfaction with pain control, functional recovery, adverse events, surgical bleeding, wound-healing complications, and blinding integrity.
详细描述
Postoperative pain after Mohs micrographic surgery and wide local excision is commonly managed with non-opioid analgesics, including acetaminophen and ibuprofen. However, some patients undergoing skin cancer surgery are older, medically complex, or receiving antithrombotic therapy, and postoperative analgesic choices may be limited. Suzetrigine is an FDA-approved non-opioid analgesic for moderate to severe acute pain in adults and may provide an alternative postoperative pain strategy.
This study is a prospective, randomized, double-blind, double-dummy, active-controlled, parallel-group Phase IV trial. Adults undergoing Mohs micrographic surgery or wide local excision for cutaneous malignancy or a skin-cancer precursor lesion of the head and neck requiring layered or more complex reconstruction will be enrolled at four M Health Fairview dermatologic surgery clinics in Minnesota.
Participants will be randomized 1:1 after surgery to receive either suzetrigine monotherapy or scheduled acetaminophen plus ibuprofen for 72 hours. Participants in the suzetrigine arm will receive a 100 mg loading dose followed by 50 mg every 12 hours through 72 hours. Participants in the standard analgesia arm will receive acetaminophen 1000 mg every 8 hours plus ibuprofen 400 mg every 6 hours through 72 hours. Matching placebo capsules will be used so that the two regimens are identical in appearance, capsule count, and dosing schedule.
Breakthrough oxycodone 5 mg every 6 hours as needed may be prescribed in either arm if a participant reports inadequately controlled pain and is assessed by a responsible clinician. Oxycodone is prescribed through routine clinical care and is not supplied automatically as study medication.
Participants will complete electronic or paper diary assessments from baseline through Day 7, with a Day 30 safety survey and routine clinical record review through 90 days after surgery. The primary endpoint is the time-averaged area under the curve of Numeric Pain Rating Scale scores over the first 24 hours after the first dose, expressed as change from baseline, and tested for non-inferiority. Secondary outcomes include rescue opioid consumption, pain through 48 and 72 hours, patient-reported recovery and satisfaction, adverse events, wound-healing complications, surgical bleeding, and blinding integrity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Biopsy-proven cutaneous malignancy of the head or neck, including melanoma, melanoma in situ, cutaneous squamous cell carcinoma, or basal cell carcinoma, or a biopsy-confirmed precursor lesion to skin cancer requiring excision
- •Planned treatment by Mohs micrographic surgery or wide local excision
- •Surgical defect requiring intermediate layered closure, complex closure, adjacent tissue transfer, or full-thickness skin graft
- •Able to take oral medications
- •Access to an electronic diary device, or willingness to use a paper backup
- •Able to provide written informed consent, with English, Hmong, or Somali language materials and interpreter support available
排除标准
- •Contraindication to ibuprofen, including active peptic ulcer disease, history of gastrointestinal bleeding, estimated glomerular filtration rate below 30 mL/min/1.73 m², or NSAID hypersensitivity
- •Moderate or severe hepatic impairment, defined as Child-Pugh Class B or C
- •Chronic heavy alcohol use
- •Known hypersensitivity to acetaminophen
- •Known hypersensitivity to opioids
- •Severe untreated obstructive sleep apnea or other respiratory compromise that would make a short course of breakthrough oxycodone unsafe
- •Concurrent use of a benzodiazepine or other sedative-hypnotic
- •Concurrent use of a strong or moderate CYP3A inhibitor, or a strong or moderate CYP3A inducer
- •Regular opioid use in the prior 30 days, meaning opioid use on most days or any standing opioid prescription
- •Body weight below 50 kg
- •Prior major bleeding on a nonsteroidal anti-inflammatory drug, or an active bleeding disorder
- •Pregnancy or breastfeeding
- •Prior adverse reaction to suzetrigine
- •Cognitive impairment precluding completion of patient-reported outcomes
- •Participation in another interventional trial within 30 days
- •Prisoners
- •Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- •Employees of the researcher
- •Students of the researcher
- •Individuals approached in emergency or acutely stressful settings
研究组 & 干预措施
Suzetrigine
Participants randomized to this arm will receive suzetrigine monotherapy for 72 hours after Mohs micrographic surgery or wide local excision. Participants will receive a 100 mg loading dose in clinic after surgery, followed by 50 mg every 12 hours through 72 hours, with matching placebo capsules at intervening dosing times to preserve blinding. Breakthrough oxycodone may be prescribed on request after same-day clinical assessment.
干预措施: Suzetrigine (Drug)
Acetaminophen Plus Ibuprofen
Participants randomized to this arm will receive the standard analgesic regimen of acetaminophen 1000 mg every 8 hours plus ibuprofen 400 mg every 6 hours for 72 hours after Mohs micrographic surgery or wide local excision, with matching placebo capsules at suzetrigine dosing times to preserve blinding. Breakthrough oxycodone may be prescribed on request after same-day clinical assessment.
干预措施: Acetaminophen Plus Ibuprofen (Drug)
结局指标
主要结局
Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 24 Hours
时间窗: Baseline through 24 hours after first study dose
The primary endpoint is the time-averaged area under the curve of Numeric Pain Rating Scale scores from 0 to 10 over the first 24 hours after the first study dose, expressed as change from baseline. The endpoint will be tested for non-inferiority of suzetrigine compared with scheduled acetaminophen plus ibuprofen.
次要结局
- Rescue Opioid Consumption Within 24 Hours(Baseline through 24 hours after first study dose)
- Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 48 Hours(Baseline through 48 hours after first study dose)
- Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 72 Hours(Baseline through 72 hours after first study dose)
- Maximum Numeric Pain Rating Scale Score(Baseline through 72 hours after first study dose)
- Adequacy of Pain Control(24 and 48 hours after first study dose)
- Patient Global Impression of Change(48 hours and Day 7 after first study dose)
- Satisfaction With Pain Control(72 hours and Day 7 after first study dose)
- Activities of Daily Living(24 hours and Day 7 after first study dose)
- Adverse Events and Serious Adverse Events(Baseline through Day 30 after surgery)
- Surgical Bleeding and Wound-Healing Complications(Baseline through 90 days after surgery)
- Study Drug Discontinuation Due to Adverse Events(Baseline through 72 hours after first study dose)
- Blinding Integrity(72 hours and Day 7 after first study dose)