Effect of Sufentanil and Ropivacaine

Anesthesia Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488291
• Other study ID #: IPMCH
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia Complications

Intervention

Drug:
• 0.25 sufentanil
with different dosage
• 0.5µg/ml sufentanil
0.5µg/ml sufentanil
• 0.1% ropivacaine
0.1% ropivacaine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS(visual analog pain score)	comparison with two groups	1 year