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Completed

NCT Number: NCT02488291

Effect of Sufentanil and Ropivacaine

The investigators study the efficacy of epidural sufentanil/ropivacaine for analgesia labor in primiparas so as to decrease perinatal complications of analgesia labor.

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Key information

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

A prospective study of 120 full-term parturients receiving labor analgesia were randomly assigned into 2 groups: the 0.5Sufen group (N=60), the 0.25Sufen group (N=60).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients had regular prenatal examinations at the outpatient clinic;
  • They were between 25 to 35 years of age)
  • They had a gestational age ≥37 weeks and < 42 weeks;
  • They had an estimated fetal weight ≥ 2,500 g and < 4,200 g.

Exclusion criteria

  • a history of spinal surgery,
  • platelet count <100×109 /L ,
  • coagulation disorder,
  • sensorimotor disorder of lower extremity,
  • leg pain,
  • puncture point infection,
  • heart disease history,
  • pulmonary disease,
  • liver and renal function disorder and
  • a history of neuropsychiatry drugs.

Treatment and study plan

0.25 sufentanil

Drug

with different dosage

Other names: opiods

0.5µg/ml sufentanil

Drug

0.5µg/ml sufentanil

Other names: opiods

0.1% Ropivacaine

Drug

0.1% ropivacaine

Other names: Local Anesthetics

Primary outcomes

  1. VAS(visual analog pain score)

    Time frame: 1 year

    comparison with two groups

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

Effect of 0.5µg/ml Sufentanil and Ropivacaine Towards Pregnant Women and Fetus in Analgesia Labor

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2015
Registry last updated
Aug 12, 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.

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