Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia

Labor Analgesia Clinical Trial

Official title:

Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02873091
• Other study ID #: NJFY2016002
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: December 27, 2016
• Start date: September 2016
• Est. completion date: October 2017

Study information

• Verified date: December 2016
• Source: Nanjing Maternity and Child Health Care Hospital
• Contact: Caijuan Li, M.A.
• Phone: 025-52226112
• Email: licaijuanyumi1228[@]126.com
• Is FDA regulated: No
• Health authority: China: Nanjing Medical University
• Study type: Interventional

Clinical Trial Summary

Sixteen million babies were born in 2010, approximately half were by cesarean. Labor analgesia should be the first choice for these parturients based on the consideration of security and humanization. However this labor analgesia rate is quite low in China (<5%) while in western country, this rate is up to 60%. Programmed intermittent epidural bolus (PIEB) is the latest technique for labor analgesia which has less neurotoxicity theoretically compared with Continuous Epidural Infusion(CEI) with Patient controlled epidural analgesia (PCEA) which is used most commonly. In that study, they reported less total local anesthetic consumption, fewer manual bolus doses and greater patient satisfaction with the PIEB technique. In China, multiple factors contribute to the reasons of low labor analgesia rate. From the patient's point of view, worrying about unsatisfied analgesia, and not adapted to the symptoms of motor block, such as inability to move their legs distressing, both are important reasons of refusing labor analgesia and preferring to cesarean delivery. Therefore, in this clinical trial, we plan to find a safer and more effective regimen for labor analgesia in Chineseparturients. This clinical trial is designed to prove PIEB used Ropivacaine is safer and more effective than CEI for labor analgesia in Chinese parturients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: October 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 40 Years

Eligibility

Inclusion Criteria:

• Subjects who agree to join this study

• Age: 22y-40y

• American Society of Anesthesiologists (ASA) physical status 1 or 2

• Gestation : 37-41 weeks

• Primipara

• Singleton fetus and head presentation

• In early labor: cervical dilation for 1-3cm

• Requesting labor epidural analgesia

Exclusion Criteria:

• Contraindication for epidural analgesia

• Height less than 150 cm or more than 170 cm

• Morbid obesity (BMI more than 35)

• High-risk pregnancy:(gestational diabetes mellitus, gestational hypertension, placenta previa, placental abruption, preeclampsia)

• Received parenteral opioids

• Unable to perform motor block evaluation tests

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Analgesia

Intervention

Procedure:
• Epidural analgesia

• Continuous epidural infusion

• Intermittent epidural bolus

Drug:
• ropivacaine

• sufentanil

Locations

Country	Name	City	State
China	Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Maternity and Child Health Care Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal visual analogue scale (VAS)	a visual analog scale (VAS) with a 10 cm vertical score ranged from "no pain" to "worst possible pain"	At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours)	No
Secondary	Maternal modified Bromage scale		At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)	No
Secondary	Subject's Satisfaction with labor epidural analgesia		At the time after childbirth	No
Secondary	Total ropivacaine and sufentanil consumption		At two hours postpartum	Yes
Secondary	Proportion of parturients requiring additional PCEA boluses		At two hours postpartum	No
Secondary	Rate of "very satisfied"and/or "satisfied",Proportion of subjects who has experienced Visual analog scale (VAS) score for pain more than 3 scale		At two hours postpartum	No
Secondary	Maternal heart rate		At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)	Yes
Secondary	Rates of cesarean delivery and instrument-assisted delivery		At time of placental delivery	Yes
Secondary	Duration of analgesia		Initiation of analgesia to 2 h postpartum (approximately 10 hours)	Yes
Secondary	Durations of labor stages		From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)	Yes
Secondary	Use of oxytocin after analgesia		At twenty-four hours postpartum	Yes
Secondary	Incidence of maternal side effects		Initiation of analgesia to 2 hour postpartum (approximately 10 hours)	Yes
Secondary	Neonatal Apgar scale		At the first and fifth minutes after baby was born	Yes
Secondary	Fetal heart rate		From initiation of analgesia to delivery (approximately 8 hours)	Yes
Secondary	Neonatal weight		At delivery	No
Secondary	Mean number of PCEA		At two hours postpartum	No
Secondary	Maternal respiratory rate		At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)	Yes
Secondary	Maternal blood pressure		At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)	Yes