Labor Pain
Conditions
Keywords
Labor, Intrathecal sufentanil, Obstetrical, Spinal analgesia
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.
Interventions
PROCEDURESpinal analgesia
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.
Sponsors
Lund University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Intrathecal sufentanil for labor pain
Exclusion criteria
Demographic, obstetrical or neonatal data is missing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epidural blood patch | 1 veek after spinal analgesia | Use of epidural blood patch |
| Maternal hypotension | 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 | During the first hour after spinal analgesia | A decrease in FHR(fetal heart rate) to 80 beats/ min for duration of 2 or more |
| Late fetal deceleration | 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 | 24 hours after initial spinal analgesia | Any use of spinal analgesia after primary spinal analgesia |
| Supplementary epidural analgesia | 24 hours after initial spinal analgesia | Any use of epidural analgesia after primary spinal analgesia |
| Maternal satisfaction with pain relief | 24 hours after spinal analgesia | Defined by parturient after delivery as very god, god, less satisfactory or bad |
| Postspinal dural puncture headache | 48 hours after spinal analgesia | Rate of postspinal dural puncture headache |
| Instrumental delivery | During childbirth | Use of instrumental delivery |
| Intrapartum Cesarean section | During childbirth | Use of intrapartum Cesarean section |
| Third- or fourth-degree perineal tear | During childbirth | Rate of third- or fourth-degree perineal tear |
| Oxytocin before spinal analgesia | 24 hours before childbirth | Any use of oxytocin before spinal analgesia |
| Oxytocin after spinal analgesia | 24 hours after spinal analgesia | Any use of oxytocin after spinal analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low Apgar score of newborn (Apgar score ≤ 7 ) | One minute and 5 minutes after birth | Number of newborns with Apgar score ≤ 7 |
| Use of neonatal intensive care | 1 week | Number of newborns requiring intensive care unit |
| Breastfeeding | 1 week | Number of infants with breastfeeding |
| Time from maternal arrival until request for SA | During childbirth | Time in minutes |
| Time from request for SA until arrival of anaesthesiologist | During childbirth | Time in minutes |
| Time from arrival of anaesthesiologist until SA | During childbirth | Time in minutes |
| Time from SA until maximal cervical dilation | During childbirth | Time in minutes |
| Time from maximal cervical dilation until delivery | During childbirth | Time in minutes |
Outcome results
None listed