Quality of Recovery Scores in Parturients With Obesity: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Difference in Obstetric Quality of Recovery Score (ObsQoR-10)
研究概览
简要总结
The prevalence of obesity has increased dramatically recently. Obesity is a pro-inflammatory state which leads to chronic low grade inflammation having different systemic effects. This may make obesity an independent risk factor for severe acute postoperative pain. No prospective studies have been conducted to specifically evaluate the quality of recovery after caesarean delivery for women with morbid obesity when compared to non-obese parturients. In addition, while there is biological plausibility to infer worse pain scores in parturients with obesity, the magnitude of this difference is unknown and information guiding adjustments in pain management are lacking.
详细描述
The prevalence of obesity has increased dramatically over the recent past in both developed and developing countries.
Obesity is a pro-inflammatory state which leads to chronic low grade inflammation. It has been well studied that this very inflammation and oxidative stress is responsible for cardiovascular pathologies seen in these patients. As a result, the post-operative period is characterized by a phase of prolonged systemic inflammatory response, which makes obesity an independent risk factor for severe acute pain. As a matter of fact, an extreme rise in IL-6 in patients with obesity has been demonstrated post-operatively.
In addition, adipose tissue acts as an endocrine organ by releasing a number of other pro-inflammatory proteins. Cytokines are known to promote various metabolic, hemodynamic and immunologic changes post-surgery, and in the setting of exaggerated inflammatory response can lead to increased pain and hemodynamic instability.
Very few studies have evaluated the recovery experience of patients with obesity in the acute postoperative period. Patients with obesity undergoing general abdominal surgery have been shown to have worse surgical outcomes, increased complication rates, and increased analgesic requirements.7 However, in spine surgery, there have been conflicting evidence supporting a difference in pain scores in patients with obesity. Despite there being no clear guidelines on post-operative pain control between these two groups, providers reported prescribing less opioid analgesics post-operatively to patients with obesity when compared to patients not suffering from this condition.
The Obstetric Quality of Recovery Score (ObsQoR) was initially developed and validated as a measure of patient reported outcome after caesarean delivery. It started as an 11-item questionnaire (ObsQoR-11), which was further simplified to 10-items (ObsQoR-10) following patient feedback where moderate and severe pain questions were combined into a single item. This tool measures pain, nausea or vomiting, dizziness, shivering, comfort, mobility, ability to hold and feed the baby, personal hygiene maintenance, and feeling in control, to provide a global inpatient postpartum quality of recovery score out of 100. A systematic review assessing measurement properties of available patient-reported outcome measures using COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) methodology, recommended ObsQoR as the best available instrument to measure functional recovery following caesarean delivery.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Term pregnancy (> 37 weeks gestational age)
- •Elective caesarean delivery
- •BMI >40 (Study Group) or BMI <30 (Control Group)
排除标准
- •Chronic pain
- •History of opioid use during pregnancy.
- •History of substance abuse disorder during pregnancy.
- •Contraindication to neuraxial opioids, acetaminophen and/or NSAIDs
- •Language barrier
- •Allergy to Opioids or NSAIDS
- •Intra-operative conversion to general anesthesia
- •Maternal Admission to ICU.
- •Neonatal admission to NICU.
结局指标
主要结局
Difference in Obstetric Quality of Recovery Score (ObsQoR-10)
时间窗: 24 hours post cesarean delivery
10-item questionnaire applied to subjects 24 hours after spinal anesthesia. Measured in a 0-100 scale where 0=poor recovery and 100=perfect recovery
次要结局
- Respiratory Depression(In post-anesthesia care unit (PACU), and every 4 hours up to 24 hours after surgery)
- Time-to-first oral opioid analgesic request(Measured in hours from the time of cesarean delivery until patient request for prescribed oral opioid analgesia, up to 24 hours from the spinal anesthetic)
- Nausea and/or Vomiting that required treatment(Absolute number of treatments required in the 24-hour time frame)
- Pruritus that required treatment(Absolute number of treatments required in the 24-hour time frame.)
- Difference in Average Numeric Rating Score (0-10 , where 0=no pain and 10= maximum pain) at specific time points in the first 24 hours(Immediately after surgery (in PACU) and every 4 hours up to 24 hours after surgery)
- Opioid Consumption in the first 24 hours(24 hours post cesarean delivery)
- Total Inpatient Opioid Consumption(up to 1 week post operatively)
- Breastfeeding(24 hours post cesarean delivery)
- Length of hospital stay(Measured in hours from the time of cesarean, up to to 1 month post operatively (average 48-72 hours))
- Time to fist mobilization(Measured in hours from the time of cesarean delivery until patient first mobilizes post operatively, up to 48 hours post operatively.)
- Time to first oral intake(Measured in hours from the time of cesarean delivery, up to 48 hours post operatively)
- Unplanned Readmission Rates(6 weeks post op)