The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia (EIEBFLA)

The Effects of Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Fever for Labor Analgesia in Primiparous Women

Epidural analgesia is associated with maternal intra-partum fever during labor. Intermittent epidural injections appear to reduce the incidence of maternal intra-partum fever compared to continuous epidural infusion during labor analgesia. However, the optimal combination of bolus volume and administrating interval has not yet been compared. The purpose of this prospective, randomized, double-blind trial was to determine how intermittent epidural bolus reduced the incidence of maternal intra-partum fever compared with continuous epidural infusion during labor.

Study Overview

• Status: Unknown
• Conditions: Pain; Neurologic Manifestations; Labor Pain; Signs and Symptoms; Pathological Conditions, Signs and Symptoms
• Intervention / Treatment: Procedure: Epidural analgesia; Procedure: Continuous epidural infusion; Procedure: Intermittent epidural bolus; Procedure: Combined spinal-epidural analgesia

• Study Type: Interventional
• Enrollment (Anticipated): 12000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Recruiting
      • Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
      • Contact: Shanwu Feng, M.D.; Phone Number: +86 25 52226112; Email: shanwufeng@163.com
      • Principal Investigator: Shanwu Feng, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Nulliparous women
• Required labor analgesia
• Chinese
• Spontaneous labor

Exclusion Criteria:

• Contraindications for epidural analgesia
• Allergic to opioids and/or local anesthetics
• Failed to performing epidural catheterization
• Organic dysfunction
• Those who were not willing to or could not finish the whole study at any time
• Using or used in the past 14 days of the monoamine oxidase inhibitors
• Alcohol addictive or narcotic dependent patients
• Subjects with a nonvertex presentation or scheduled induction of labor
• Twin gestation and breech presentation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Epidural analgesia (EA) with continuous epidural infusion(CEI)	Procedure: Epidural analgesia; Procedure: Continuous epidural infusion
Active Comparator: 2; Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI)	Procedure: Continuous epidural infusion; Procedure: Combined spinal-epidural analgesia
Active Comparator: 3; Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)	Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus
Active Comparator: 4; Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)	Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus
Active Comparator: 5; Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)	Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus
Active Comparator: 6; Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)	Procedure: Intermittent epidural bolus; Procedure: Combined spinal-epidural analgesia
Active Comparator: 7; Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)	Procedure: Intermittent epidural bolus; Procedure: Combined spinal-epidural analgesia
Active Comparator: 8; Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)	Procedure: Intermittent epidural bolus; Procedure: Combined spinal-epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maternal oral and tympanic temperature	At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of cesarean delivery and instrument-assisted delivery	At time of placental delivery
Duration of analgesia	Initiation of analgesia to 2 h postpartum (approximately 10 hours)
Durations of labor stages	From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
Use of oxytocin after analgesia	At twenty-four hours postpartum
Incidence of maternal side effects	Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
Neonatal Apgar scale	At the first and fifth minutes after baby was born
Fetal heart rate	From initiation of analgesia to delivery (approximately 8 hours)
Neonatal weight	At delivery
Breastfeeding success at 6 weeks after vaginal delivery	At the sixth week after successful delivery
Maternal serum Interleukin-1β	At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-1β	At time of placental delivery
Maternal serum Interleukin-6	At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-6	At time of placental delivery
Maternal serum Interleukin-10	At time of placental delivery and 3, 6 and 12 hours later
Cord serum Interleukin-10	At time of placental delivery
Maternal serum tumor necrosis factor-α	At time of placental delivery and 3, 6 and 12 hours later
Cord serum tumor necrosis factor-α	At time of placental delivery
Regression and correlation analyses between maternal and cord serum cytokines	At twelve hours postpartum
Placental routine pathologic examination	At time of placental delivery
Maternal and cord blood gase analysis	At time of placental delivery
Maternal modified Bromage scale and visual analogue scale	At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture	At two hours postpartum
Indications of cesarean delivery	Initiation of analgesia to placental delivery (approximately 8 hours)
Maternal satisfaction with analgesia	At two hours postpartum
Low back pain at 3 months after vaginal delivery	At the third month after vaginal delivery
Neonatal Neurologic and Adaptive Capacity Score	At 30 min, 2 h, and 24 h after baby was born
Maximal oxytocin dose	At twenty-four hours postpartum
Neonatal sepsis evaluation	At 30 min after baby was born
Neonatal antibiotic treatment	One week after baby was born
Maternal heart rate, respiratory rate, and blood pressure	At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Highest thoracic sensory level to alcohol	At three hours after initiation of analgesia
Uterine contraction	At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Neonatal rectal temperature	At delivery, 30 min after delivery, and 1 h after delivery
Maternal group B streptococcus (GBS) colonization	At time of initiation of analgesia
Number of vaginal examinations, duration from rupture of the membranes to delivery, mode of membranes ruptured	From initiation of analgesia to delivery (approximately 8 hours)
Uterine artery, umbilical artery and vein, fetus middle cerebral artery by ultrasound	At time of initiation of analgesia and hourly thereafter until delivery (approximately 8 hours)
Maternal serum epinephrine, norepinephrine, insulin, glucagon, corticotropin releasing hormone, adrenocorticotropic hormone, cortisol, blood glucose, oxytocin, prostaglandin E2 and prostaglandin F2 alpha	At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Maternal postpartum depression	At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)

Collaborators and Investigators

• Sponsor: ShanWu Feng, M.D.
• Investigators: Study Director: Shanwu Feng, M.D., Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 7, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 17, 2012

Study Record Updates

• Last Update Posted (Estimate): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Epidural analgesia; Labor analgesia; Fever; Patient controlled epidural analgesia; Combined spinal-epidural analgesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Labor Pain; Neurologic Manifestations
• Other Study ID Numbers: NJMCHH-2012-A010; 08NMUM063 (Other Grant/Funding Number: Nanjing Medical University); YKK08119 (Other Grant/Funding Number: Nanjing Department of Health); YKK11058 (Other Grant/Funding Number: Nanjing Department of Health)