NCT03377595撤回4 期
Post-cesarean Section Analgesic Safety and Efficacy of EXPAREL (Liposomal Bupivacaine) Infiltration Locally Versus Transversus Abdominis Plane Infiltration
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Total opioid consumption
研究概览
简要总结
Evaluating the safety and efficacy of EXPAREL (Liposomal Bupivacaine ) for pain control in patients undergoing scheduled cesarean section by giving it either as infiltration in Transversus Abdominis Plane after finishing the procedure or through wound infiltration into the fascia prior to closure of skin
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Females 18 years of age and older at screening.
- •Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
- •ASA (American Society of Anesthesiologists) physical status 1, 2, or 3 are able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
排除标准
- •BMI > or equal to 40 or otherwise not anatomically appropriate to undergo a TAP block.
- •Planned general anesthetic
- •Cesarean delivery via vertical skin incision
- •Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
- •Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
- •Severely impaired renal or hepatic function (eg, serum creatinine level >2 mg/dL [176.8 µmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase [AST] level >3 times the upper limit of normal , or serum alanine aminotransferase [ALT] level >3 times the upper limit of normal.)
- •Subjects at an increased risk for bleeding or a coagulation disorder (defined as platelet count less than 80, 000 × 103/mm3 or international normalized ratio greater than 1.5).
- •Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the postsurgical period for pain that is not strictly related to the surgery and which may confound the postsurgical assessments.
- •Clinically significant medical disease in either the mother or baby that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease in the mother that would constitute a contraindication to participation in the study or cause the mother to be unable to comply with the study requirements.
- •History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- •Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
- •Previous participation in an EXPAREL study.
- •Any clinically significant event or condition uncovered during the surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
- •Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration.
- •Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours.
研究组 & 干预措施
TAP (Transversus Abdominis Plane) block
Experimental
20-mL dose of EXPAREL 266 mg expanded in volume with 20 mL normal saline plus 20 mL 0.25% bupivacaine for a total volume of 60 mL m.A 2-point classic TAP block will be performed under ultrasound guidance within 1 hour (± 30 minutes) following skin incision closure of the C-section.
干预措施: Exparel (Drug)
Wound infiltration
Experimental
20 mL of EXPAREL 266 mg expanded in volume with 40 mL normal saline for a total volume of 60 mL, infiltrated in the fascia prior to skin closure with attention to infiltrate the angles of the incision.
干预措施: Exparel (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: 72 hours
Total opioid medication use by patient after having cesarean section
次要结局
- Time to first rescue opioid pain medication(72 hours)
- Percentage of opioid-free subjects(24,48, and 72 hours)
- Patient's satisfaction(through 72 hours post-op or at discharge)
- VAS (visual analogue scale) pain scores(at 6, 12, 18, 24, 30, 36, 42, 48, and 72 hours after surgery)
- Number of participants with EXPAREL related adverse events(through day 14 post-op)
- Allergic reactions attributable to local anesthetic use(through day14 post-op)
- Wound complications(through day 14 post-op)
研究者
研究点 (1)
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