Spinal Sufentanil for Relief of Labor Pain in Primi- and Multiparous Parturients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Labor Pain
- Sponsor
- Lund University
- Enrollment
- 164
- Primary Endpoint
- Instrumental delivery
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Intrathecal sufentanil for labor pain
Exclusion Criteria
- •Demographic, obstetrical or neonatal data is missing
Outcomes
Primary Outcomes
Instrumental delivery
Time Frame: During childbirth
Use of instrumental delivery
Late fetal deceleration
Time Frame: 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
Time Frame: 24 hours after initial spinal analgesia
Any use of spinal analgesia after primary spinal analgesia
Maternal hypotension
Time Frame: 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
Time Frame: 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
Time Frame: 24 hours after initial spinal analgesia
Any use of epidural analgesia after primary spinal analgesia
Maternal satisfaction with pain relief
Time Frame: 24 hours after spinal analgesia
Defined by parturient after delivery as very god, god, less satisfactory or bad
Postspinal dural puncture headache
Time Frame: 48 hours after spinal analgesia
Rate of postspinal dural puncture headache
Intrapartum Cesarean section
Time Frame: During childbirth
Use of intrapartum Cesarean section
Third- or fourth-degree perineal tear
Time Frame: During childbirth
Rate of third- or fourth-degree perineal tear
Oxytocin before spinal analgesia
Time Frame: 24 hours before childbirth
Any use of oxytocin before spinal analgesia
Oxytocin after spinal analgesia
Time Frame: 24 hours after spinal analgesia
Any use of oxytocin after spinal analgesia
Epidural blood patch
Time Frame: 1 veek after spinal analgesia
Use of epidural blood patch
Secondary Outcomes
- 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)