A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses

May 19, 2016 updated by: Leopoldo Ferrer, Fundación Santa Fe de Bogota
The analgesic approach in labor can be done in different ways, among which the neuraxial approach has shown the best analgesic results and fetal outcomes. Currently, programmed epidural intermittent bolus has been included in the neuraxial approach for a better distribution of the solution into the epidural space as compared with the continuous infusion strategy. In this study, the investigators seek to compare both strategies in 132 laboring women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia
        • Hospital Universitario Fundación Santa Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • At term pregnancy
  • Laboring patients requiring epidural analgesia

Exclusion Criteria:

  • American Society of Anesthesiologists physical status > or equal than 3
  • allergy to local anesthesics
  • Neuraxial contraindications
  • Hemodynamic instability
  • Systemic disease such as diabetes mellitus or hypertension
  • Chronic usage of analgesics
  • Disease associated to pregnancy such as gestational diabetes, preeclampsia, fetal malformations among others

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Continuous Epidural Infusion
  1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.
  2. A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered.
  3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
  4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
Drug: Bupivacaine and Fentanyl Initial Dose
10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution)
Drug: Bupivacaine and Fentanyl: Continuous Epidural Infusion
0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour)
Drug: Rescue Bolus
Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
Drug: Lidocaine
If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
EXPERIMENTAL: Programmed Intermittent Epidural Bolus
  1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.
  2. A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour.
  3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
  4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered .
Drug: Bupivacaine and Fentanyl Initial Dose
10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution)
Drug: Rescue Bolus
Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
Drug: Lidocaine
If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
Drug: Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus
A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain level in laboring women measured by the Numeric Analog Scale
Time Frame: one year
to compare pain level in each arm once epidural analgesia is applied until birth
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Santa Fe de Bogota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCEI-3413-2015

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