Spinal Sufentanil for Relief of Labor Pain in Primi- and Multiparous Parturients
Conditions: Labor Pain
Sponsor: Lund University

Title:                                                                                            
Spinal sufentanil for relief of labor pain in primi- and multiparous parturients 
NCT ID not yet assigned 
Document Date: 05/29/2019 
 
1 INTRODUCTION 
Any parturient should be offered safe and effective analgesia at short notice during 
labor, and therapeutic options are pharmacological (nitrous oxide, non-opioid and 
opioid analgesics, regional and neuraxial nerve blocks) and non-pharmacological 
(hypnosis, biofeedback, intra- or subcutaneous sterile water injection, immersion in 
water, aromatherapy, relaxation techniques, acupuncture or acupressure, massage, 
transcutaneous electrical nerve stimulation) interventions 1. Neuraxial (epidural and/or 
spinal) nerve block is the most effective method of intrapartum pain relief in 
contemporary clinical practice 2. Intrathecal administration of local anaesthetic and/or 
opioid provides effective, although transient, pain relief during spontaneous vaginal 
delivery. However, although spinal opioid is being used more for obstetric analgesia, 
effects and adverse effects of intrathecal sufentanil alone for relief of labor pain have 
not been compared between primi- and multiparous parturients.  
This descriptive study was designed to evaluate effects and potential adverse 
effects of spinal sufentanil for obstetrical pain relief in primi- and multiparous 
parturients.  
 
 
2  MATERIAL AND METHODS 
 
2.1  Ethical approval 
The study design was approved by the regional Human Research Ethics Review 
Board, Lund, Sweden (Dnr 2015/687).  
 
2.2  Study design and setting 
This descriptive study is based on retrospective data on obstetrical management 
of patients at the maternity ward of the Central Hospital in Kristianstad, Sweden, 
between 7th January 2013 and 29th July 2016. 
 

2.3  Patients 
We included 164 (82 primi- and 82 multiparous) obstetrical patients given 
intrathecal sufentanil for labor pain. Demographic, obstetrical, and neonatal 
information in patients admitted to the maternity ward was obtained from the local 
obstetrical hospital database (ObstetrixTM, Cerner Sverige AB, Stockholm, 
Sweden).   
 
2.4  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 blood pressure by more than 30 % from the baseline level despite 
infusion of crystalloid was defined to indicate maternal hypotension.  
 
2.5  Study data 
Maternal demographics (age, height, weight, body mass index), obstetrical 
(medical history, gestational age, cervical dilation, progress of labor, indication 
and time for SA, hypotension, use of oxytocin, fetal bradycardia or late 
deceleration during the first hour after SA, supplementary analgesia, instrumental 
delivery, intrapartum Cesarean section (CS), third- or fourth-degree perineal tear, 
maternal satisfaction with pain relief, postdural puncture headache, use of epidural 
blood patch), and neonatal (time of birth, fetal heart rate (FHR), Apgar score, 
weight at birth, use of neonatal intensive care, feeding) data was obtained as 
reported above. 
 
2.6  Statistical analysis 
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 
proportions in percent with 95 % confidence interval (CI).  
Parametric data was compared with two-tailed unpaired student’s t-test, and 
proportions analyzed with Fisher’s exact test.  
Probability (P) values < 0.05 were considered statistically significant.