Effect of Sufentanil and Ropivacaine

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia Complications
• Intervention / Treatment: Drug: 0.5µg/ml sufentanil; Drug: 0.1% ropivacaine; Drug: 0.25 sufentanil

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).

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.5 sufentanil; 0.5µg/ml sufentanil, 0.1% ropivacaine for 6ml/h	Drug: 0.5µg/ml sufentanil; 0.5µg/ml sufentanil; Other Names: opiods; Drug: 0.1% ropivacaine; 0.1% ropivacaine; Other Names: Local Anesthetics
Experimental: 0.25 sufentanil; 0.25µg/ml sufentanil, 0.1% ropivacaine for 6ml/h	Drug: 0.1% ropivacaine; 0.1% ropivacaine; Other Names: Local Anesthetics; Drug: 0.25 sufentanil; with different dosage; Other Names: opiods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS(visual analog pain score)	comparison with two groups	1 year

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Zeyong Yang, M.D., Fudan University, Shanghai Jiaotong University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 20, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: anesthesia; Epidural; Analgesia labor; Perinatal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics; Anesthetics, Local; Ropivacaine; Sufentanil; Dsuvia
• Other Study ID Numbers: IPMCH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No