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.
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.
Study Type
OBSERVATIONAL
Enrollment
164
Spinal analgesia (SA) was provided by a resident or specialist anaesthesiologist with the patient in a sitting or a recumbent position. A pencil-point needle, primarily 27 G (0.4 mm), otherwise 25 G (0.5 mm), was used for transdermal intrathecal administration of 2.0 ml of sufentanil 5 µg/ml (Sufenta®, Janssen-Cilag AB, Solna, Sweden) at low-lumbar level. Blood pressure was recorded before, immediately after, and at five-minute intervals for 20 minutes after the block. Any decrease in systolic pressure to \<100 mmHg or a decrease \>20% from the baseline level despite infusion of crystalloid was defined to indicate maternal hypotension.
Maternal hypotension
Any fall in systolic pressure to \<100 mmHg or a decrease \>20% from the baseline level
Time frame: During the first 20 minutes after spinal analgesia with 5 minutes intervals
Fetal bradycardia
A decrease in FHR(fetal heart rate) to 80 beats/ min for duration of 2 or more
Time frame: During the first hour after spinal analgesia
Late fetal deceleration
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
Time frame: During the first hour after spinal analgesia
Supplementary spinal analgesia
Any use of spinal analgesia after primary spinal analgesia
Time frame: 24 hours after initial spinal analgesia
Supplementary epidural analgesia
Any use of epidural analgesia after primary spinal analgesia
Time frame: 24 hours after initial spinal analgesia
Instrumental delivery
Use of instrumental delivery
Time frame: During childbirth
Intrapartum Cesarean section
Use of intrapartum Cesarean section
Time frame: During childbirth
Third- or fourth-degree perineal tear
Rate of third- or fourth-degree perineal tear
Time frame: During childbirth
Oxytocin before spinal analgesia
Any use of oxytocin before spinal analgesia
Time frame: 24 hours before childbirth
Oxytocin after spinal analgesia
Any use of oxytocin after spinal analgesia
Time frame: 24 hours after spinal analgesia
Maternal satisfaction with pain relief
Defined by parturient after delivery as very god, god, less satisfactory or bad
Time frame: 24 hours after spinal analgesia
Postspinal dural puncture headache
Rate of postspinal dural puncture headache
Time frame: 48 hours after spinal analgesia
Epidural blood patch
Use of epidural blood patch
Time frame: 1 veek after spinal analgesia
Low Apgar score of newborn (Apgar score ≤ 7 )
Number of newborns with Apgar score ≤ 7
Time frame: One minute and 5 minutes after birth
Use of neonatal intensive care
Number of newborns requiring intensive care unit
Time frame: 1 week
Breastfeeding
Number of infants with breastfeeding
Time frame: 1 week
Time from maternal arrival until request for SA
Time in minutes
Time frame: During childbirth
Time from request for SA until arrival of anaesthesiologist
Time in minutes
Time frame: During childbirth
Time from arrival of anaesthesiologist until SA
Time in minutes
Time frame: During childbirth
Time from SA until maximal cervical dilation
Time in minutes
Time frame: During childbirth
Time from maximal cervical dilation until delivery
Time in minutes
Time frame: During childbirth
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