The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia

NCT ID: NCT01708668

Last Updated: 2015-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type PROCEDURE

Continuous epidural infusion

Intervention Type PROCEDURE

2

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

Group Type ACTIVE_COMPARATOR

Combined spinal-epidural analgesia

Intervention Type PROCEDURE

Continuous epidural infusion

Intervention Type PROCEDURE

3

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

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type PROCEDURE

Intermittent epidural bolus

Intervention Type PROCEDURE

4

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

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type PROCEDURE

Intermittent epidural bolus

Intervention Type PROCEDURE

5

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

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type PROCEDURE

Intermittent epidural bolus

Intervention Type PROCEDURE

6

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

Group Type ACTIVE_COMPARATOR

Combined spinal-epidural analgesia

Intervention Type PROCEDURE

Intermittent epidural bolus

Intervention Type PROCEDURE

7

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

Group Type ACTIVE_COMPARATOR

Combined spinal-epidural analgesia

Intervention Type PROCEDURE

Intermittent epidural bolus

Intervention Type PROCEDURE

8

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

Group Type ACTIVE_COMPARATOR

Combined spinal-epidural analgesia

Intervention Type PROCEDURE

Intermittent epidural bolus

Intervention Type PROCEDURE

Interventions

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Epidural analgesia

Intervention Type PROCEDURE

Combined spinal-epidural analgesia

Intervention Type PROCEDURE

Continuous epidural infusion

Intervention Type PROCEDURE

Intermittent epidural bolus

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ShanWu Feng, M.D.

OTHER

Sponsor Role lead

Responsible Party

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ShanWu Feng, M.D.

Department of Anesthesiology, Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu, China, 210004

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shanwu Feng, M.D.

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

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Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shanwu Feng, M.D.

Role: CONTACT

+86 25 52226112

Facility Contacts

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Shanwu Feng, M.D.

Role: primary

+86 25 52226112

Other Identifiers

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08NMUM063

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

YKK08119

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

YKK11058

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NJMCHH-2012-A010

Identifier Type: -

Identifier Source: org_study_id

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