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CompletedNCT02488291Updated Aug 12, 2020

Effect of Sufentanil and Ropivacaine

An interventional study of 0.25 sufentanil and 0.5µg/ml sufentanil in Anesthesia Complications, sponsored by Fudan University. Completed. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2020-08-12.

Sponsored by Fudan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
25 Years to 35 Years
Sex
Female
01

Study summary

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

Read the 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).

02

Conditions studied

  • Anesthesia Complications

Keywords

  • Epidural
  • Analgesia labor
  • Perinatal
  • anesthesia
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    0.5 sufentanil

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

    Drug: 0.5µg/ml sufentanil · Drug: 0.1% ropivacaine

  • Experimental
    0.25 sufentanil

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

    Drug: 0.25 sufentanil · Drug: 0.1% ropivacaine

Interventions

  • Drug0.25 sufentanil

    with different dosage

    Also known as: opiods

  • Drug0.5µg/ml sufentanil

    0.5µg/ml sufentanil

    Also known as: opiods

  • Drug0.1% ropivacaine

    0.1% ropivacaine

    Also known as: Local Anesthetics

06

What researchers measure

Primary outcomes

  1. VAS(visual analog pain score)

    comparison with two groups

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Statistical analysis plan · Jun 30, 2016

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02488291
Lead sponsor
Fudan University
Collaborators
Shanghai Jiao Tong University School of Medicine
Responsible party
Zeyong Yang (Hospital, Fudan University) — Principal investigator
First posted
Jul 2, 2015
Start date
Apr 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Aug 12, 2020

Study contacts

Zeyong Yang, M.D.
principal investigator · Fudan University, Shanghai Jiaotong University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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