Relationship Between Sex Hormones, Postoperative Pain and Opioid Use: the Role of Immune Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Levels of IL-10 and IL-6
研究概览
简要总结
Aim 1- To identify relationships between sex hormone levels and postoperative pain and opioid use.
Aim 2: To determine whether the effects of testosterone on postoperative pain and opioid use are mediated by immune factors
详细描述
After signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. Surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected.
In addition, before or after the surgery, patients and their parents/guardians will be interviewed. The interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use.
Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. Based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.After signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. Surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected.
In addition, before or after the surgery, patients and their parents/guardians will be interviewed. The interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use.
Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. Based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pediatric female patients between the ages 11-16 undergoing an orthopedic (trauma and non-trauma) surgical procedure involving a long bone or joint, or the spine, English speaking
排除标准
- •Pregnancy; Diagnosis of chronic pain, Psychiatric, developmental or neurological disorders, Disorders that are associated with pubertal maturation (e.g., precocious puberty).
研究组 & 干预措施
Postoperative patients
Pediatric female patients undergoing a surgical procedure
干预措施: Pain (Behavioral)
Postoperative patients
Pediatric female patients undergoing a surgical procedure
干预措施: Opioid use (Behavioral)
结局指标
主要结局
Levels of IL-10 and IL-6
时间窗: Baseline
Immune factors
Sex hormone level of estrogen
时间窗: Baseline
Sex hormone level of Testosterone
时间窗: Baseline
Sex hormone level of progesterone
时间窗: Baseline
次要结局
未报告次要终点
研究者
Hadas Nahman-Averbuch
Asst Prof of Anesthesiology
Washington University School of Medicine