Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- QST Pain Threshold
研究概览
简要总结
This is a prospective observational case-control study comparing quantitative sensory testing data preformed during the third trimester of pregnancy and within 24 hours postpartum in women on medication-assisted treatment for opioid use disorder (OUD) to a gestational age-controlled cohort of women who do not have OUD.
The primary goal is to measure elements of quantitative sensory testing including temperature pain threshold, temperature pain tolerance, and thermal and mechanical temporal summation for patients with opioid use disorder on medication-assisted treatment (MAT), and compare these results to gestational age matched controlled pregnant patients not on MAT.
详细描述
The objective of this study is to measure elements of quantitative sensory testing including temperature pain threshold, temperature pain tolerance, and thermal and mechanical temporal summation for patients with opioid use disorder on medication-assisted treatment (MAT), and compare these results to gestational age matched controlled pregnant patients not on MAT.
The hypothesis is that women requiring maintenance opioids during pregnancy will have a significant difference in pain sensitivity in the third trimester and immediately postpartum as compared to women who did not require maintenance opioids during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Subjects that will be included in the prospective cohort group:
- •individuals at least 18 years of age
- •at least 28 weeks gestation (third trimester)
- •on medication-assisted treatment for opioid use disorder, including methadone or suboxone.
- •Patients who will be included in the control group:
- •individuals at least 18 years of age
- •at least 28 weeks gestation (third trimester)
- •have not been on been on opioids in the past 12 months.
排除标准
- •Those who are unable to participate in informed consent discussions,
- •Unable to give informed consent for any reason,
- •Not fluent in English (surveys are validated in English language)
- •Unable to participate fully in all study procedures for any reason including sensory deficits, scar tissue, or infection at any QST sites.
结局指标
主要结局
QST Pain Threshold
时间窗: Completed within 24 hours postpartum/ after delivery
Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain
QST Pain Tolerance
时间窗: Completed within 24 hours postpartum/ after delivery
Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable.
QST Pain threshold
时间窗: Completed at a time point antepartum/ before delivery
Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain
次要结局
未报告次要终点
研究者
Grace Lim, MD, MS
Associate Professor
University of Pittsburgh