Spinal Sufentanil for Relief of Labor Pain in Primi- and Multiparous Parturients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 主要终点
- Instrumental delivery
研究概览
简要总结
Background: This descriptive study was designed to evaluate effects and adverse effects of spinal sufentanil for relief of labor pain in primi- and multiparous women.
Methods: The retrospective study design was approved by the regional Human Research Ethics Review Board, Lund, Sweden (Dnr 2015/687). The investigators included 164 (82 primi- and 82 multiparous) obstetrical patients given 10 µg of intrathecal sufentanil for labor pain. Any maternal hypotension, third- or fourth-degree perineal tear, intrapartum Cesarean section, abnormal fetal heart rate, low Apgar score, use of neonatal intensive care, postdural puncture headache, epidural blood patch, and breastfeeding problem was recorded. Major outcome measures were maternal satisfaction with pain relief, and provision of supplementary analgesia.
详细描述
A total sample size of 150 parturients had been calculated to enable differences of at least 20 % versus 5.0 % in proportions of obstetrical and neonatal problems between (equal numbers of) primi- and multiparous mothers to be statistically confirmed with 80 % power and 95 % probability.
Descriptive parametric data is reported as mean ± standard deviation (SD), and descriptive non-parametric data as median with interquartile range (IQR). Proportions are reported in percent with 95 % confidence interval (CI).
Parametric data was compared with two-tailed unpaired student's t-test, and non-parametric data with the Mann-Whitney U-test. Proportions were analyzed with two-tailed Fisher's exact test.
Probability (P) values at < 0.05 were considered statistically significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Intrathecal sufentanil for labor pain
排除标准
- •Demographic, obstetrical or neonatal data is missing
结局指标
主要结局
Instrumental delivery
时间窗: During childbirth
Use of instrumental delivery
Late fetal deceleration
时间窗: During the first hour after spinal analgesia
FHR(fetal heart rate)\<FHR 40 min beats/ min below the baseline or less than 90/beats min for duration of 2 minutes or more
Supplementary spinal analgesia
时间窗: 24 hours after initial spinal analgesia
Any use of spinal analgesia after primary spinal analgesia
Maternal hypotension
时间窗: During the first 20 minutes after spinal analgesia with 5 minutes intervals
Any fall in systolic pressure to \<100 mmHg or a decrease \>20% from the baseline level
Fetal bradycardia
时间窗: During the first hour after spinal analgesia
A decrease in FHR(fetal heart rate) to 80 beats/ min for duration of 2 or more
Supplementary epidural analgesia
时间窗: 24 hours after initial spinal analgesia
Any use of epidural analgesia after primary spinal analgesia
Maternal satisfaction with pain relief
时间窗: 24 hours after spinal analgesia
Defined by parturient after delivery as very god, god, less satisfactory or bad
Postspinal dural puncture headache
时间窗: 48 hours after spinal analgesia
Rate of postspinal dural puncture headache
Intrapartum Cesarean section
时间窗: During childbirth
Use of intrapartum Cesarean section
Third- or fourth-degree perineal tear
时间窗: During childbirth
Rate of third- or fourth-degree perineal tear
Oxytocin before spinal analgesia
时间窗: 24 hours before childbirth
Any use of oxytocin before spinal analgesia
Oxytocin after spinal analgesia
时间窗: 24 hours after spinal analgesia
Any use of oxytocin after spinal analgesia
Epidural blood patch
时间窗: 1 veek after spinal analgesia
Use of epidural blood patch
次要结局
- Breastfeeding(1 week)
- Time from maternal arrival until request for SA(During childbirth)
- Time from request for SA until arrival of anaesthesiologist(During childbirth)
- Time from maximal cervical dilation until delivery(During childbirth)
- Low Apgar score of newborn (Apgar score ≤ 7 )(One minute and 5 minutes after birth)
- Use of neonatal intensive care(1 week)
- Time from arrival of anaesthesiologist until SA(During childbirth)
- Time from SA until maximal cervical dilation(During childbirth)