Patient Recovery After Orthopedic Surgery Under Nerve Blocks With Sedation in Foot and Ankle Patients (FA) and Nerve Block With Either Sedation or General Anesthesia (GA) in Total Shoulder Arthroplasty (TSA) Patients. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Intensity of Nausea
研究概览
简要总结
Nausea after surgery may negatively influence patient satisfaction, may delay discharge, and cause unexpected hospital admissions. The trend toward ambulatory surgery has increased the focus on postoperative nausea, but published evidence is not based on standardized criteria for assessment. Therefore, the results for postoperative nausea are very diverse, especially reports on nausea incidence after regional anesthesia, i.e. spinal anesthesia. When peripheral nerve blocks have been applied for postoperative pain control, they significantly reduce postoperative pain, opioid consumption and side effects; patients receiving general anesthesia (GA) and nerve blocks are thought likely to have less nausea than patients receiving GA alone. This study is a pilot study looking at the incidence and intensity of nausea after orthopedic surgery under nerve blocks in foot and ankle (FA) patients and under nerve blocks with either sedation or GA in total shoulder arthroplasty (TSA) patients. The results of this study will help power a future randomized controlled trial, comparing the incidence and intensity of nausea in FA patients receiving GA through laryngeal mask airway (LMA) versus spinal anesthesia.
详细描述
Nausea after surgery may negatively influence patient satisfaction, may delay discharge, and cause unexpected hospital admissions. The trend toward ambulatory surgery has increased the focus on postoperative nausea, but published evidence is not based on standardized criteria for assessment. Therefore, the results for postoperative nausea are very diverse, especially reports on nausea incidence after regional anesthesia, i.e. spinal anesthesia. This is due to varying data sources, such as nurse notes and/or patient reports, and a lack of a consistent antiemetic and pain medication protocol. The results of this study will help power a future randomized controlled trial, comparing the incidence and intensity of nausea in FA patients receiving GA through laryngeal mask airway (LMA) versus spinal anesthesia.
When peripheral nerve blocks have been applied for postoperative pain control, they significantly reduce postoperative pain, opioid consumption and side effects; patients receiving GA and nerve blocks are thought likely to have less nausea than patients receiving GA alone, due a reduction in pain leading to reduction in need for emetogenic opioids.
This study is a pilot study looking at the incidence and intensity of nausea after orthopedic surgery under nerve blocks in foot and ankle (FA) patients and under nerve blocks with either sedation or GA in total shoulder arthroplasty (TSA) patients. At the author's institution, TSA is commonly performed with a brachial plexus block and either GA or intravenous sedation. TSA patients represent a model system for the effect of GA on nausea among patients receiving nerve blocks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery
- •Age 18-99
- •Patients who are capable to provide informed consent and answer questions in English,
- •For FA patients: Planned neuraxial anesthesia + nerve block for postsurgical analgesia,
- •For TSA patients: Planned brachial plexus nerve block + either general anesthesia or IV sedation.
排除标准
- •Incapable to provide informed consent
- •Contraindications for regional or LMA anesthesia (anticoagulation, infection at injection site)
- •Anticipated difficult airway
- •Body mass index>35
- •Anticipated surgical procedure time less than 1 hour or more than 4 hours,
- •History of severe postoperative nausea and/or vomiting
- •American Society of Anesthesiologists physical status classification >3
- •Neuropathy
- •Pregnant or nursing women
- •Chronic opioid use (daily use of opioids one month prior to surgery/ patients requiring chronic pain interventions)
- •Prone position planned for surgery
- •Obstructive sleep apnea
- •Known allergy/sensitivity to any study medications
结局指标
主要结局
Intensity of Nausea
时间窗: 2 hours after surgery
On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission
时间窗: 1 hour after surgery
Yes/no response to whether patient had nausea in the PACU 1 hour after admission. If yes, investigators will seek out intensity
Number of Participants With Nausea
时间窗: Average 2 hours after surgery (at discharge from the recovery room after surgery)
Yes/no question. If yes, the investigators will then seek intensity of nausea.
次要结局
- Antiemetic Consumption(Duration of stay in recovery room after surgery (average 2 hours))
- Number of Participants With Emesis(Average 2 hours after surgery (at discharge from the recovery room after surgery))
- Opioid Dose Among Patients Receiving Opioids in the PACU(Duration of PACU stay (Average 2 hours))
- Number of Participants Satisfied With Anesthesia(PACU before discharge, an average of 2 hours)
- Patients Receiving Opioids in the PACU(PACU stay before discharge (average 2 hours))