NCT04141527

Spinal Sufentanil for Obstetric Analgesia

Spinal Sufentanil for Relief of Labor Pain in Primi- and Multiparous Parturients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 164 (actual)
• Sponsor: Lund University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Labor Pain

Interventions

Type	Name	Description
PROCEDURE	Spinal 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.

Timeline

• Start date: 2016-06-15
• Primary completion: 2016-08-25
• Completion: 2017-06-21
• First posted: 2019-10-28
• Last updated: 2020-09-03