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Spinal Sufentanil for Obstetric Analgesia

L

Lund University

Status

Completed

Conditions

Labor Pain

Treatments

Procedure: Spinal analgesia

Study type

Observational

Funder types

Other

Identifiers

NCT04141527
DNR2015/687

Details and patient eligibility

About

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.

Full description

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.

Enrollment

164 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

Intrathecal sufentanil for labor pain

Exclusion criteria

Demographic, obstetrical or neonatal data is missing

Trial design

164 participants in 2 patient groups

Primiparous women
Description:
82 primiparous obstetrical patients given intrathecal sufentanil for labor pain.
Treatment:
Procedure: Spinal analgesia
Multiparous women
Description:
82 multiparous obstetrical patients given intrathecal sufentanil for labor pain.
Treatment:
Procedure: Spinal analgesia

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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