Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Narcotic use
研究概览
简要总结
In recent years, there has been an emphasis on the creation of "enhanced-recovery", "fast-track" or "multi-modal" pathways to improve perioperative care (1-4). The goal of these programs is to reduce the length of hospital stay, decrease narcotic usage while improving pain control, accelerate post-operative recovery, and expedite return to baseline functional status. Pathways often are developed by a team of surgeons, nurses, pain specialists, anesthesiologists and other support staff. Postoperative components often involve multi-modal analgesia, early return to activity and early return to a regular diet. The goal of this study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery with a primary goal of decreasing narcotic usage.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women >/= 18 years old
- •undergoing pelvic organ prolapse or incontinence surgery with the Urogynecology department
排除标准
- •<18 years old
- •women unwilling or unable to consent
- •same-day-discharge surgery
- •history of chronic pain for which they use medications
- •current or active history of narcotic abuse
- •sleep apnea
- •liver or kidney dysfunction
- •sulfa allergy
研究组 & 干预措施
Multimodal
Patients in the multimodal arm will receive the following:
- preoperative celebrex and gabapentin
- intraoperative IV acetaminophen, dexamethasone, zofran
- postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
- patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics
干预措施: Gabapentin (Drug)
Standard
Patients will be given the following:
- no preoperative medications
- intraoperative medications per anesthesia
- postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed
干预措施: oral acetaminophen (Drug)
Standard
Patients will be given the following:
- no preoperative medications
- intraoperative medications per anesthesia
- postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed
干预措施: oral ibuprofen (Drug)
Standard
Patients will be given the following:
- no preoperative medications
- intraoperative medications per anesthesia
- postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed
干预措施: percocet (Drug)
Standard
Patients will be given the following:
- no preoperative medications
- intraoperative medications per anesthesia
- postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed
干预措施: vicodin (Drug)
Standard
Patients will be given the following:
- no preoperative medications
- intraoperative medications per anesthesia
- postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed
干预措施: dilaudid (Drug)
Multimodal
Patients in the multimodal arm will receive the following:
- preoperative celebrex and gabapentin
- intraoperative IV acetaminophen, dexamethasone, zofran
- postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
- patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics
干预措施: Celebrex (Drug)
Multimodal
Patients in the multimodal arm will receive the following:
- preoperative celebrex and gabapentin
- intraoperative IV acetaminophen, dexamethasone, zofran
- postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
- patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics
干预措施: IV acetaminophen (Drug)
Multimodal
Patients in the multimodal arm will receive the following:
- preoperative celebrex and gabapentin
- intraoperative IV acetaminophen, dexamethasone, zofran
- postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
- patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics
干预措施: oral acetaminophen (Drug)
Multimodal
Patients in the multimodal arm will receive the following:
- preoperative celebrex and gabapentin
- intraoperative IV acetaminophen, dexamethasone, zofran
- postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
- patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics
干预措施: oral ibuprofen (Drug)
Multimodal
Patients in the multimodal arm will receive the following:
- preoperative celebrex and gabapentin
- intraoperative IV acetaminophen, dexamethasone, zofran
- postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
- patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics
干预措施: Oxycodone (Drug)
Multimodal
Patients in the multimodal arm will receive the following:
- preoperative celebrex and gabapentin
- intraoperative IV acetaminophen, dexamethasone, zofran
- postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
- patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics
干预措施: dilaudid (Drug)
Multimodal
Patients in the multimodal arm will receive the following:
- preoperative celebrex and gabapentin
- intraoperative IV acetaminophen, dexamethasone, zofran
- postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
- patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics
干预措施: Dexamethasone (Drug)
Multimodal
Patients in the multimodal arm will receive the following:
- preoperative celebrex and gabapentin
- intraoperative IV acetaminophen, dexamethasone, zofran
- postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
- patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics
干预措施: zofran (Drug)
结局指标
主要结局
Narcotic use
时间窗: intraoperative, immediate postoperative and 1 week postoperative
Narcotic use will be evaluated at all stages of the preoperative care: operating room, hospital floor and at the 1 week postoperative time point
次要结局
- Constipation(one week postoperatively)
- Pain(postoperative day #1 and postoperative week #1)
- Nausea(intraoperatively, postoperatively)