Effect of Sufentanil and Ropivacaine

Fudan University

Status: Completed

Conditions: Anesthesia Complications

Treatments: Drug: 0.1% ropivacaine; Drug: 0.5µg/ml sufentanil; Drug: 0.25 sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02488291

IPMCH

Details and patient eligibility

About

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

Full 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).

Enrollment: 120 patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

0.5 sufentanil

Experimental group

Description:

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

Treatment:

Drug: 0.5µg/ml sufentanil

Drug: 0.1% ropivacaine

0.25 sufentanil

Experimental group

Description:

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

Treatment:

Drug: 0.25 sufentanil

Drug: 0.1% ropivacaine