Status:
COMPLETED
Combined Implementation of Dural Puncture Epidural and Programmed Intermittent Epidural Bolus for Labor Analgesia
Lead Sponsor:
Shanghai First Maternity and Infant Hospital
Conditions:
Labor Pain
Labor Analgesia
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief Summary
This study intends to carry out a prospective, randomized double-blind study to evaluate the safety and efficacy of the combined implementation of Dural puncture epidural (DPE) technique and Programme...
Detailed Description
Epidural (EPL) technique is the standard technique for labor analgesia, but can be associated with slow onset and inadequate sacral spread, unilateral or patchy sensory blockade, motor impairment. The...
Eligibility Criteria
Inclusion
- women requeste labor analgesia
- ASA I or II
- at 37-42 weeks' gestation
- nulliparous
- singleton pregnancy, vertex presentation
- visual Numerical Rating Scale (VNRS) at requesting analgesia \> 5 (NRPS 0-10)
- cervical dilatation \< 5 cm
Exclusion
- patient refusal to participate in the study
- age \<20 years or \>40 years
- body mass Index(BMI)\>50 (Kg/m2)
- clinically significant diseases of pregnancy (i.e.,gestational hypertension, preeclampsia, gestational placenta previa, placental abruption diabetes)
- contraindications to neuraxial analgesia
- drug abuse
- conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity) and known anomalies
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03366935
Start Date
October 10 2017
End Date
June 30 2018
Last Update
August 1 2018
Active Locations (1)
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1
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Shanghai, China