Spinal Sufentanil for Obstetric Analgesia

Completed

• Conditions: Labor Pain
• Interventions: Procedure: Spinal analgesia

• Registration Number: NCT04141527
• Lead Sponsor: Lund University

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.

Study Timeline

• Study Start: 2016-06-15
• Primary Completion: 2016-08-25
• Study Completion: 2017-06-21
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

Inclusion Criteria

Intrathecal sufentanil for labor pain

Exclusion Criteria

Demographic, obstetrical or neonatal data is missing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primiparous women	Spinal analgesia	82 primiparous obstetrical patients given intrathecal sufentanil for labor pain.
Multiparous women	Spinal analgesia	82 multiparous obstetrical patients given intrathecal sufentanil for labor pain.

Primary Outcome Measures

Name	Time	Method
Instrumental delivery	During childbirth	Use of instrumental delivery
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
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
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
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
Epidural blood patch	1 veek after spinal analgesia	Use of epidural blood patch

Secondary Outcome Measures

Name	Time	Method
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 maximal cervical dilation until delivery	During childbirth	Time in minutes
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
Time from arrival of anaesthesiologist until SA	During childbirth	Time in minutes
Time from SA until maximal cervical dilation	During childbirth	Time in minutes