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Spinal Sufentanil for Obstetric Analgesia

NCT04141527 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 164

Last updated 2020-09-03

No results posted yet for this study

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.

Conditions

  • Labor Pain

Interventions

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.

Sponsors & Collaborators

  • Lund University

    lead OTHER

Principal Investigators

  • Jonas Åkeson, Professor · Lund University Skåne University Hospital

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-15
Primary Completion
2016-08-25
Completion
2017-06-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141527 on ClinicalTrials.gov