NCT05017246终止2 期
A Randomized Trial Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy on the Gynecologic Oncology Service.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course
研究概览
简要总结
To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than patients who have epidural anesthesia with PCA (EPCA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ≥18 years old
- •Undergoing non-emergent exploratory laparotomy with the Gynecologic Oncology service
- •No clinical or laboratory evidence of end organ failure:
- •If available:
- •Platelets > 100 K/cumm
- •Hemoglobin > 8.0 g/dl
- •Serum creatinine <1.5 mg/dl
- •Creatine clearance (CrCl) ≥30 based on the original Cockcroft-Gault formula adjusted for weight.
- •INR <1.3 reference range
- •All other lab values obtained as part of general preoperative work-up must be ≤1.5x normal laboratory value.
排除标准
- •Patients not giving consent to participate in the study
- •Unable to complete self-report pain questionnaire
- •Moderate to severe kidney or liver failure per lab criteria as outlined
- •Inability to hold anticoagulant medications for a safe amount of time per current ASRA guidelines
- •Contraindication to lumbar puncture or epidural placement, per acute pain management service such as known coagulopathy or history of clotting disorders, history of scoliosis or lumbar fusion, infection at site of entry, or current systemic infection
- •Complete bowel obstruction
- •Contraindication to intravenous lidocaine
- •No known pregnancy and not lactating.
- •Currently septic
- •Patient currently taking more than 30 MME a day preoperatively (for >30 days)
- •BMI >50kg/m2
- •Intolerance/contraindication or allergy to receiving non-steroidal anti-inflammatory drugs or acetaminophen or any other medications in the pre-operative order set
研究组 & 干预措施
Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)
Active Comparator
- Standard of care at Washington University School of Medicine/Barnes-Jewish Hospital
- Day of surgery: preoperative tylenol, gabapentin, celebrex, and epidural dosing per standard protocol.
- Intraoperative: dexamethasone and epidural bupivacaine
- Day of surgery postoperative: hydromorphone PCA, toradol, ibuprofen, tylenol, epidural bupivacaine
- Postoperative: hydromorphone PCA, ibuprofen, oxycodone
干预措施: Bupivacaine (Drug)
Intrathecal morphine with intraoperative lidocaine infusion
Experimental
- Day of surgery: tylenol, gabapentin, celebrex, and preoperative intrathecal morphine one time injection (150mcg)
- Intraoperative: dexamethasone and lidocaine infusion 1 mg/kg ideal body weight
- Day of surgery postoperative: toradol, ibuprofen, tylenol
- Postoperative: ibuprofen, oxycodone, and hydromorphone prn
干预措施: Morphine (Drug)
Intrathecal morphine with intraoperative lidocaine infusion
Experimental
- Day of surgery: tylenol, gabapentin, celebrex, and preoperative intrathecal morphine one time injection (150mcg)
- Intraoperative: dexamethasone and lidocaine infusion 1 mg/kg ideal body weight
- Day of surgery postoperative: toradol, ibuprofen, tylenol
- Postoperative: ibuprofen, oxycodone, and hydromorphone prn
干预措施: Lidocaine (Drug)
结局指标
主要结局
Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course
时间窗: Postoperatively while patient is in hospital (estimated to be 4 days)
次要结局
- Patient Satisfaction With Pain Control(Day of hospital discharge (estimated to be day 4))
- Change in Pain Scores(Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up)
- 30 Day Readmission Rate(Through day 30)
- Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE)(From day of surgery (day 1) to 6 weeks after surgery)
- Rate of Persistent Pain(At 6 week follow-up)
- Rate of Postoperative Ileus(Postoperatively while patient is in hospital (estimated to be 4 days))
- Length of Hospital Stay(Estimated to be 4 days)
- Rate of Postoperative Hypotension(Up to 48 hours after surgery)
研究者
研究点 (1)
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