NCT02488291

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

June 20, 2015

Last Update Submit

August 10, 2020

Conditions

Anesthesia Complications

Keywords

EpiduralAnalgesia laborPerinatalanesthesia

Outcome Measures

Primary Outcomes (1)

  • VAS(visual analog pain score)

    comparison with two groups

    1 year

Study Arms (2)

0.5 sufentanil

EXPERIMENTAL

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

Drug: 0.5µg/ml sufentanilDrug: 0.1% ropivacaine

0.25 sufentanil

EXPERIMENTAL

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

Drug: 0.25 sufentanilDrug: 0.1% ropivacaine

Interventions

0.25 sufentanilDRUG

with different dosage

Also known as: opiods
0.25 sufentanil
0.5µg/ml sufentanilDRUG

0.5µg/ml sufentanil

Also known as: opiods
0.5 sufentanil
0.1% ropivacaineDRUG

0.1% ropivacaine

Also known as: Local Anesthetics
0.25 sufentanil0.5 sufentanil

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

SufentanilRopivacaineAnesthetics, Local

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Zeyong Yang, M.D.

    Fudan University, Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hospital

Study Record Dates

First Submitted

June 20, 2015

First Posted

July 2, 2015

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 12, 2020

Record last verified: 2020-08