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

ShanWu Feng, M.D.

Status: Unknown

Conditions: Signs and Symptoms; Neurologic Manifestations; Labor Pain; Pathological Conditions, Signs and Symptoms; Pain

Treatments: Procedure: Epidural analgesia; Procedure: Combined spinal-epidural analgesia; Procedure: Continuous epidural infusion; Procedure: Intermittent epidural bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT01708668

NJMCHH-2012-A010

YKK08119 (Other Grant/Funding Number)

08NMUM063 (Other Grant/Funding Number)

YKK11058 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 12,000 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12,000 participants in 8 patient groups

1

Active Comparator group

Description:

Epidural analgesia (EA) with continuous epidural infusion(CEI)

Treatment:

Procedure: Continuous epidural infusion

Procedure: Epidural analgesia

2

Active Comparator group

Description:

Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI)

Treatment:

Procedure: Combined spinal-epidural analgesia

Procedure: Continuous epidural infusion

3

Active Comparator group

Description:

Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)

Treatment:

Procedure: Intermittent epidural bolus

Procedure: Epidural analgesia

4

Active Comparator group

Description:

Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)

Treatment:

Procedure: Intermittent epidural bolus

Procedure: Epidural analgesia

5

Active Comparator group

Description:

Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)

Treatment:

Procedure: Intermittent epidural bolus

Procedure: Epidural analgesia

6

Active Comparator group

Description:

Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)

Treatment:

Procedure: Combined spinal-epidural analgesia

Procedure: Intermittent epidural bolus

7

Active Comparator group

Description:

Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)

Treatment:

Procedure: Combined spinal-epidural analgesia

Procedure: Intermittent epidural bolus

8

Active Comparator group

Description:

Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)

Treatment:

Procedure: Combined spinal-epidural analgesia

Procedure: Intermittent epidural bolus