The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia

NCT01708668 | Unknown DMC

• 4 other identifiers: NJMCHH-2012-A01008NMUM063YKK08119YKK11058
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Fever; Patient controlled epidural analgesia; Labor analgesia; Epidural analgesia; Combined spinal-epidural analgesia

Outcome Measures

Primary Outcomes (1)

• Maternal oral and tympanic temperature

  At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)

Secondary Outcomes (38)

• 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

Study Arms (8)

1

ACTIVE COMPARATOR

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

Procedure: Epidural analgesia; Procedure: Continuous epidural infusion

2

ACTIVE COMPARATOR

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

Procedure: Combined spinal-epidural analgesia; Procedure: Continuous epidural infusion

3

ACTIVE COMPARATOR

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

Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus

4

ACTIVE COMPARATOR

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

Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus

5

ACTIVE COMPARATOR

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

Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus

6

ACTIVE COMPARATOR

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

Procedure: Combined spinal-epidural analgesia; Procedure: Intermittent epidural bolus

7

ACTIVE COMPARATOR

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

Procedure: Combined spinal-epidural analgesia; Procedure: Intermittent epidural bolus

8

ACTIVE COMPARATOR

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

Procedure: Combined spinal-epidural analgesia; Procedure: Intermittent epidural bolus

Interventions

Epidural analgesia PROCEDURE

1; 3; 4; 5

Combined spinal-epidural analgesia PROCEDURE

2; 6; 7; 8

Continuous epidural infusion PROCEDURE

1; 2

Intermittent epidural bolus PROCEDURE

3; 4; 5; 6; 7; 8

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ShanWu Feng, M.D.: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210004, China

RECRUITING

MeSH Terms

Conditions

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

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Nervous System Diseases; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Shanwu Feng, M.D.

  Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Shanwu Feng, M.D.

CONTACT

+86 25 52226112; shanwufeng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology, Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu, China, 210004

Study Record Dates

• First Submitted: October 7, 2012
• First Posted: October 17, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: June 1, 2017
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

CN (1)