CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 164 enrolled
Drug / intervention
Spinal analgesiaprocedure
Likely dose
Not stated in record
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Search/NCT04141527
NCT04141527N/ACompleted

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

Lund University·observational·Posted Oct 28, 2019·Updated Sep 3, 2020

In Brief

An observational study evaluating Spinal analgesia for Labor Pain. Completed, enrolled 164 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLabor Pain
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 28, 2019
Enrollment StartJun 15, 2016
Primary CompletionAug 25, 2016
Study CompletionJun 21, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.7 years ago

Interventions

Spinal analgesiaprocedure

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.