Do Experience of Pain and 30-Day Surgery Outcomes Differ in Robotic Bariatric Surgery Patients Treated With Narcotic vs. Non-narcotic Pain Management Protocols?
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
This study aims to better understand the role that narcotic vs. non-narcotic multimodal pain management play in patients' pain following bariatric surgery (Laproscopic Surgery and Robotic Assisted Surgery). Participation in this study will last approximately 90 days following surgery. During that 90 day period, participants will be asked to report pain and nausea every 4 hours to a study coordinator or nurse while they are recovering in the hospital. Following discharge from the hospital patients will be asked to report pain, nausea, and any medical changes 7 days, 30 days, and 90 days from surgical date.
The procedures and medications used in this study are FDA approved medical therapies and are part of Standard of Care for this population. This study aims to therapeutically investigate efficacy of the proposed pain management regimens. The procedures and individual medications are not the subject of research as they are considered routine well established and documented interventions for obesity and the treatment of post operative pain.
详细描述
The majority of patients who undergo surgery will require treatment for the management of acute post-surgical pain. The use of narcotics after elective surgical procedures has contributed to the current opioid epidemic. Striking the right balance of treatment and use of narcotics vs. non-narcotic medications is at a crucial juncture in surgery.
Post-surgical pain influences a patient's perception of quality of care, physical recovery, and length of stay. The threat of poor postoperative pain control is a fear of many patients who will have a surgical procedure. The post- operative pain regimen is traditionally chosen by the operating surgeon rather than in a shared decision-making model where patients are educated about choice and participate in management. This is one of many factors influencing use of medications for post-operative pain. If a patient develops longer term, chronic postsurgical pain it may lead to disability and diminish quality of life, increase healthcare utilization, increase healthcare costs, and result in loss of productivity.
Morbid obesity is a global epidemic that increases the risk of developing related complications such as cardiac failure, type 2 diabetes, hypertension, hyperlipidemia, degenerative joint disease with the development of chronic pain and decreased mobility, and sleep apnea. In 2013 and 2014, 50% of the population had or had been affected by obesity, defined as a BMI ≥30mg/kg2. An established and effective treatment for weight loss is elective bariatric surgery.
Laparoscopic bariatric surgery (>90% of cases) is associated with less postoperative pain than open surgery, however, opioids are still used frequently for analgesia. Opioid analgesia comes with many side effects including nausea, constipation, risk of postoperative ileus, hypopnea, hypoxemia, delayed ambulation and mortality. This patient population is at increased risk for hypoventilation and narcotic related post-operative complications.
In the BUMCP department of bariatric surgery, we began employing a post-operative multimodal pain control protocol in November of 2017 and noticed improvement in pain control, declining levels of nausea and a decrease in the length of stay with our patient population. All medications and surgical interventions are considered approved standard of care in surgery. Previous studies have shown that employing a multimodal pain control protocol, even intraoperatively, influences postoperative pain control, nausea, emesis as well as chronic postoperative pain. In mid-2018 we began offering patients tap blocks which we believe have offered patients more consistent post- operative pain control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Treating surgeon will not be blinded to randomizations. Anesthesiologist providing the Tap Block will be blinded to narcotic arm and unblinded to Tap vs No Tap. Study Coordinator will be blinded to Tap vs No Tap. Statistician will be unblinded to both groups at end of study for final analysis.
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
- •Laparoscopic or Robotic Sleeve Gastrectomy bariatric surgery scheduled electively from the BUMCP Bariatric Clinic
- •BMI>35kg/m2
- •Patient of Principal Investigator or Co-Investigator
- •18 years or older
排除标准
- •Chronic Pain Management on narcotics at New Patient visit or placed on narcotics prior to surgery
- •Re-operative bariatric surgery procedures
- •Admitted to the ICU after surgery
- •Unable to walk 200ft
- •Allergic to narcotics, steroids, or other medications used in the protocol
- •Use of insulin to treat diabetes
- •Chronic Kidney Disease - stage 4 or greater
- •Significant hepatic disease
- •Carries a diagnosis of Pulmonary Hypertension
- •Carries a diagnosis of Congestive Heart Failure
研究组 & 干预措施
non-narcotic regimen with TAP block
Patient will receive Tap Block and will be administered Non-narcotic Pain Regimen post-operatively
干预措施: non-narcotic regimen with TAP block (Drug)
non-narcotic regimen with no TAP block
Patient will not receive TAP block and will be administered Non-narcotic Pain Regimen post-operatively
干预措施: non-narcotic regimen with no TAP block (Drug)
结局指标
主要结局
postoperative pain
时间窗: discharge or 24 hours postoperative, whichever is first
Patient reported postoperative pain using the Wong Baker Faces pain scale. The scale shows a series of six faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable. Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
次要结局
- Hospital length of stay(post-operative until patient discharge or up to 90 days, whichever comes first)
- Postoperative nausea(post-operative until patient discharge or up to 90 days, whichever comes first)
- 200 foot ambulation(post-operative until patient discharge or up to 90 days, whichever comes first)
- Readmissions(up to 30-day postoperatively)
研究者
Christine Lovato
Clinical Assistant Professor, Surgery
University of Arizona