Skip to main content
OpenTrials
Completed

NCT Number: NCT04141527

Spinal Sufentanil for Obstetric Analgesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Intrathecal sufentanil for labor pain

Exclusion criteria

Demographic, obstetrical or neonatal data is missing

Treatment and study plan

Spinal analgesia

Procedure

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.

Primary outcomes

  1. Maternal hypotension

    Time frame: 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

  2. Fetal bradycardia

    Time frame: During the first hour after spinal analgesia

    A decrease in FHR(fetal heart rate) to 80 beats/ min for duration of 2 or more

  3. Late fetal deceleration

    Time frame: 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

  4. Supplementary spinal analgesia

    Time frame: 24 hours after initial spinal analgesia

    Any use of spinal analgesia after primary spinal analgesia

  5. Supplementary epidural analgesia

    Time frame: 24 hours after initial spinal analgesia

    Any use of epidural analgesia after primary spinal analgesia

  6. Instrumental delivery

    Time frame: During childbirth

    Use of instrumental delivery

  7. Intrapartum Cesarean section

    Time frame: During childbirth

    Use of intrapartum Cesarean section

  8. Third- or fourth-degree perineal tear

    Time frame: During childbirth

    Rate of third- or fourth-degree perineal tear

  9. Oxytocin before spinal analgesia

    Time frame: 24 hours before childbirth

    Any use of oxytocin before spinal analgesia

  10. Oxytocin after spinal analgesia

    Time frame: 24 hours after spinal analgesia

    Any use of oxytocin after spinal analgesia

  11. Maternal satisfaction with pain relief

    Time frame: 24 hours after spinal analgesia

    Defined by parturient after delivery as very god, god, less satisfactory or bad

  12. Postspinal dural puncture headache

    Time frame: 48 hours after spinal analgesia

    Rate of postspinal dural puncture headache

  13. Epidural blood patch

    Time frame: 1 veek after spinal analgesia

    Use of epidural blood patch

Secondary outcomes

  1. Low Apgar score of newborn (Apgar score ≤ 7 )

    Time frame: One minute and 5 minutes after birth

    Number of newborns with Apgar score ≤ 7

  2. Use of neonatal intensive care

    Time frame: 1 week

    Number of newborns requiring intensive care unit

  3. Breastfeeding

    Time frame: 1 week

    Number of infants with breastfeeding

  4. Time from maternal arrival until request for SA

    Time frame: During childbirth

    Time in minutes

  5. Time from request for SA until arrival of anaesthesiologist

    Time frame: During childbirth

    Time in minutes

  6. Time from arrival of anaesthesiologist until SA

    Time frame: During childbirth

    Time in minutes

  7. Time from SA until maximal cervical dilation

    Time frame: During childbirth

    Time in minutes

  8. Time from maximal cervical dilation until delivery

    Time frame: During childbirth

    Time in minutes

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Oct 28, 2019
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.