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Clinical Trials/NCT02488291
NCT02488291
Completed
Not Applicable

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

Fudan University0 sites120 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
0.5µg/ml sufentanil
Conditions
Anesthesia Complications
Sponsor
Fudan University
Enrollment
120
Primary Endpoint
VAS(visual analog pain score)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
June 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zeyong Yang

Hospital

Fudan University

Eligibility Criteria

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.

Arms & Interventions

0.5 sufentanil

0.5µg/ml sufentanil, 0.1% ropivacaine for 6ml/h

Intervention: 0.5µg/ml sufentanil

0.5 sufentanil

0.5µg/ml sufentanil, 0.1% ropivacaine for 6ml/h

Intervention: 0.1% ropivacaine

0.25 sufentanil

0.25µg/ml sufentanil, 0.1% ropivacaine for 6ml/h

Intervention: 0.25 sufentanil

0.25 sufentanil

0.25µg/ml sufentanil, 0.1% ropivacaine for 6ml/h

Intervention: 0.1% ropivacaine

Outcomes

Primary Outcomes

VAS(visual analog pain score)

Time Frame: 1 year

comparison with two groups

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