Clinical trial NCT04141527: Spinal Sufentanil for Obstetric Analgesia
Official title: Spinal Sufentanil for Relief of Labor Pain in Primi- and Multiparous Parturients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: Labor
Intrathecal sufentanil
Obstetrical
Spinal analgesia
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 164
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primi- and multiparous obstetrical patients at the maternity ward of the Central Hospital in Kristianstad, Sweden, between 7th January 2013 and 29th July 2016

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.

Eligibility criteria: Inclusion Criteria:

Intrathecal sufentanil for labor pain

Exclusion Criteria:

Demographic, obstetrical or neonatal data is missing

Primary outcomes:
measure: Maternal hypotension
timeFrame: During the first 20 minutes after spinal analgesia with 5 minutes intervals
measure: Fetal bradycardia
timeFrame: During the first hour after spinal analgesia
measure: Late fetal deceleration
timeFrame: During the first hour after spinal analgesia
measure: Supplementary spinal analgesia
timeFrame: 24 hours after initial spinal analgesia
measure: Supplementary epidural analgesia
timeFrame: 24 hours after initial spinal analgesia
measure: Instrumental delivery
timeFrame: During childbirth
measure: Intrapartum Cesarean section
timeFrame: During childbirth
measure: Third- or fourth-degree perineal tear
timeFrame: During childbirth
measure: Oxytocin before spinal analgesia
timeFrame: 24 hours before childbirth
measure: Oxytocin after spinal analgesia
timeFrame: 24 hours after spinal analgesia
measure: Maternal satisfaction with pain relief
timeFrame: 24 hours after spinal analgesia
measure: Postspinal dural puncture headache
timeFrame: 48 hours after spinal analgesia
measure: Epidural blood patch
timeFrame: 1 veek after spinal analgesia
Secondary outcomes:
measure: Low Apgar score of newborn (Apgar score ≤ 7 )
timeFrame: One minute and 5 minutes after birth
measure: Use of neonatal intensive care
timeFrame: 1 week
measure: Breastfeeding
timeFrame: 1 week
measure: Time from maternal arrival until request for SA
timeFrame: During childbirth
measure: Time from request for SA until arrival of anaesthesiologist
timeFrame: During childbirth
measure: Time from arrival of anaesthesiologist until SA
timeFrame: During childbirth
measure: Time from SA until maximal cervical dilation
timeFrame: During childbirth
measure: Time from maximal cervical dilation until delivery
timeFrame: During childbirth
Other outcomes:
Locations:
Study officials:
affiliation: Lund University Skåne University Hospital
name: Jonas Åkeson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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