Effect of Sufentanil and Ropivacaine

NCT ID: NCT02488291

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-06-30

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).

Conditions

Anesthesia Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

0.5 sufentanil

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

Group Type: EXPERIMENTAL

0.5µg/ml sufentanil

Intervention Type: DRUG

0.5µg/ml sufentanil

0.1% ropivacaine

Intervention Type: DRUG

0.1% ropivacaine

0.25 sufentanil

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

Group Type: EXPERIMENTAL

0.25 sufentanil

Intervention Type: DRUG

with different dosage

0.1% ropivacaine

Intervention Type: DRUG

0.1% ropivacaine

Interventions

0.25 sufentanil

with different dosage

Intervention Type: DRUG

0.5µg/ml sufentanil

0.5µg/ml sufentanil

Intervention Type: DRUG

0.1% ropivacaine

0.1% ropivacaine

Intervention Type: DRUG

Other Intervention Names

opiods; opiods; Local Anesthetics

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zeyong Yang

Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeyong Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University, Shanghai Jiaotong University

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IPMCH

Identifier Type: -

Identifier Source: org_study_id