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临床试验/NCT03330119
NCT03330119终止3 期

Determining the Effect of an "Alternate Recovery Protocol" Versus Current Standard of Care After Cesarean Section

Brest, Norman A., M.D.1 个研究点 分布在 1 个国家目标入组 1,494 人开始时间: 2017年10月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
1,494
试验地点
1
主要终点
Narcotic Utilization

研究概览

简要总结

This randomized controlled trial will compare two different approaches to patient recovery after cesarean section: the current standard of care versus an alternate management protocol. The goal of this study is to investigate whether an "alternate management" protocol after cesarean sections will yield the same results as alternate management in other surgical fields, including decreased narcotic consumption and quicker return of bowel function, without compromising patient morbidity or satisfaction.

The investigators will assess postoperative narcotic consumption as the primary outcome. Secondary outcomes will be return of bowel function, length of hospital stay, pain control, patient satisfaction, post-operative complications, and overall morbidity and mortality.

Hypothesis: Initiating the alternate management protocol for cesarean sections will decrease narcotic consumption and hasten return of bowel function, without compromising patient satisfaction, level of pain control, or post-operative morbidity.

详细描述

"Enhanced recovery" is a multi-modal, evidence based approach to peri-operative care, with the goal of accelerating recovery and return to normal activity after surgery. Initially introduced in colorectal surgery, some of the key changes in management include: preoperative patient education, reduction in preoperative fasting, peri-operative euvolemia, early removal of urinary catheters, multimodal and standing analgesia, early postoperative mobilization, and earlier return to a regular diet. Results have shown stable pain control with a decrease in narcotic consumption, a quicker return of bowel function, and decreased length of hospital stay and cost with no change in level of patient satisfaction, morbidity, or readmission rate. The thought is that these interventions speed recuperation by attenuating the stress response associated with surgery, subsequently decreasing time spent in the hospital and improving quality of life.

The largest retrospective cohort study demonstrating the successful implementation of the "enhanced recovery" protocol in gynecology was conducted at the Mayo Clinic, published in 2013. This protocol was created by general gynecologists, gynecology oncologists, urogynecologists, anesthesiologists, pharmacists, and nursing, and was initiated as a quality improvement project. This "enhanced recovery" protocol was used as the template for our alternate management order set. The results showed an 80% reduction in opioid consumption, stable pain scores and patient satisfaction, a 1 day earlier return of bowel function, and 4 day reduction in hospital stay with subsequent significant cost savings. An obstetric alternate management protocol was created at Lankenau, trying to incorporate the most current recommendations in "enhanced recovery" while accounting for issues unique to obstetric patients. This protocol is currently being used by certain obstetricians.

The only literature published on "enhanced recovery" being implemented in the field of obstetrics was an observational study conducted with 708 C-sections at the Jessop Wing Obstetric Unit, in Sheffield, England, published in 2015. See below for the protocol used. The development of an obstetric "enhanced recovery" plan resulted from a desire for earlier discharge following cesarean section, due to pressure on national health service budgets to cut costs. There was an increase in day 1 discharges following uncomplicated cesarean sections from 1.6% to 25 % with the above mentioned protocol, and a stable 30 day readmission rate. Their conclusion was that "an enhanced recovery program was successfully implemented... Many of the interventions were straightforward and could be adopted easily elsewhere."

A somewhat controversial element of the "enhanced recovery" protocol is the use of gabapentin in pregnancy. Gabapentin is a Category C drug, meaning that risk cannot be ruled out in pregnancy and that the drug should be given if potential benefits outweigh potential risks. Our alternate management order set includes giving 1 dose of 600mg of pre-operative gabapentin. There have been many papers documenting its safety when given as a single dose pre-operatively. A randomized controlled trial published in 2011 in the Society of Obstetric Anesthesia and Perinatology, evaluated the peri-operative use of gabapentin for cesarean sections. Neonatal outcomes were evaluated for the gabapentin group, involving 600mg pre-operatively, as well as the placebo group. There was no significant difference in neonatal outcomes. A second study published in 2015 in the American Society of Anesthesiologists also showed no difference in neonatal outcomes with a single pre-operative dose of 600mg gabapentin. Lactmed, a database that lists drugs and dietary supplements that may affect breastfeeding, endorsed by the American Academy of Pediatrics, states that "maternal doses of gabapentin up to 2.1 grams daily produce relatively low levels in infant serum," and that " a single PO dose of 600 mg prior to cesarean section appeared to have no effect on breastfeeding initiation."

Given that the national cesarean section rate in the United States is 32.2%, implementing an "enhanced recovery" protocol in obstetrics could have a huge impact on care for women in the post-partum period. The widespread adoption of "enhanced recovery" stems from evidence showing reduced narcotic consumption, earlier return to normal activities, and even reduced morbidity in some studies. From a post-partum standpoint, given the increased risk of DVT until 6 weeks post-partum, and the additional increased risk after cesarean section, encouraging ambulation and return to normal activity seems beneficial. Also, the potential to decrease narcotic use has great implications in both the post- partum and post- operative period. The CDC has recently published guidelines on prescribing opioids, given that opioid abuse is a growing epidemic in this country. The American Congress of Obstetricians and Gynecologist had responded saying that physicians would try to combat the use of prescription opioids across the country and that they should be using current best prescribing practices and all possible options for multimodal pain relief. Additionally, the American Academy of Pediatrics published an update to their Transfer of Drugs and Therapeutics in Human Breast Milk Series in 2013. The AAP states that acetaminophen and ibuprofen should be used as first line therapy for post-partum pain management, and discourages the use of codeine, hydrocodone, and oxycodone when breast feeding. One study found that as high as 20% of infants exposed to oxycodone through breast milk had central nervous system depression. Also, the state of Pennsylvania has started a breast feeding quality improvement project, called the Keystone 10 Initiative, developed by the department of health. The goal is to promote and support breastfeeding to "improve the health of mothers and babies," through changes such as more skin to skin contact and less time infants spend in the nursery. Given that the most common side effect of narcotic use is somnolence, seen up to 42% of the time, this may interfere with the mother's ability to care for her newborn. Therefore, it is clear that an "enhanced recovery" protocol after cesarean sections has potential to improve care post-operatively and post-partum on multiple levels.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Scheduled to undergo a cesarean section

排除标准

  • Existing diagnosis of chronic pain
  • Need to undergo a vertical skin incision
  • AST > 50; ALT > 70
  • Platelets below 80,000 on admission
  • Need to undergo general anesthesia
  • Tubal ligation at time of Cesarean section
  • Prior or known allergy to any of the medications being utilized in this study

研究组 & 干预措施

Alternate Management

Experimental

干预措施: Alternate Management (Drug)

Control

Placebo Comparator

The regular Lankenau cesarean section order set.

干预措施: Control (Drug)

结局指标

主要结局

Narcotic Utilization

时间窗: From time of consent until hospital discharge (3 days)

total narcotic utilization measured with Morphine Milligram Equivalent (MME) The conversion scale being used will be the Center for Disease Control and Prevention Morphine Equivalent Score. Lower scores represent less opioid use and a better outcome. Higher scores represent more opioid use and a worse outcome.

次要结局

未报告次要终点

研究者

发起方
Brest, Norman A., M.D.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Norman A. Brest

Principle Investigator

Brest, Norman A., M.D.

研究点 (1)

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