Spinal Sufentanil for Obstetric Analgesia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Procedure: Spinal analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intrathecal sufentanil for labor pain Exclusion Criteria: Demographic, obstetrical or neonatal data is missing
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primiparous women<br>82 primiparous obstetrical patients given intrathecal sufentanil for labor pain. | Procedure: Spinal analgesia<br>* 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.<br>|
| Multiparous women<br>82 multiparous obstetrical patients given intrathecal sufentanil for labor pain. | Procedure: Spinal analgesia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal hypotension | Any fall in systolic pressure to <100 mmHg or a decrease >20% from the baseline level | During the first 20 minutes after spinal analgesia with 5 minutes intervals | 
| Fetal bradycardia | A decrease in FHR(fetal heart rate) to 80 beats/ min for duration of 2 or more | During the first hour after spinal analgesia | 
| Late fetal deceleration | 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 | During the first hour after spinal analgesia | 
| Supplementary spinal analgesia | Any use of spinal analgesia after primary spinal analgesia | 24 hours after initial spinal analgesia | 
| Supplementary epidural analgesia | Any use of epidural analgesia after primary spinal analgesia | 24 hours after initial spinal analgesia | 
| Instrumental delivery | Use of instrumental delivery | During childbirth | 
| Intrapartum Cesarean section | Use of intrapartum Cesarean section | During childbirth | 
| Third- or fourth-degree perineal tear | Rate of third- or fourth-degree perineal tear | During childbirth | 
| Oxytocin before spinal analgesia | Any use of oxytocin before spinal analgesia | 24 hours before childbirth | 
| Oxytocin after spinal analgesia | Any use of oxytocin after spinal analgesia | 24 hours after spinal analgesia | 
| Maternal satisfaction with pain relief | Defined by parturient after delivery as very god, god, less satisfactory or bad | 24 hours after spinal analgesia | 
| Postspinal dural puncture headache | Rate of postspinal dural puncture headache | 48 hours after spinal analgesia | 
| Epidural blood patch | Use of epidural blood patch | 1 veek after spinal analgesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Apgar score of newborn (Apgar score ≤ 7 ) | Number of newborns with Apgar score ≤ 7 | One minute and 5 minutes after birth | 
| Use of neonatal intensive care | Number of newborns requiring intensive care unit | 1 week | 
| Breastfeeding | Number of infants with breastfeeding | 1 week | 
| Time from maternal arrival until request for SA | Time in minutes | During childbirth | 
| Time from request for SA until arrival of anaesthesiologist | Time in minutes | During childbirth | 
| Time from arrival of anaesthesiologist until SA | Time in minutes | During childbirth | 
| Time from SA until maximal cervical dilation | Time in minutes | During childbirth | 
| Time from maximal cervical dilation until delivery | Time in minutes | During childbirth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor, Intrathecal sufentanil, Obstetrical, Spinal analgesia