Back to resultsA Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Bupivacaine and Fentanyl Initial Dose
Bupivacaine and Fentanyl: Continuous Epidural Infusion
Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus
Rescue Bolus
Lidocaine
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain focused on measuring analgesia, epidural, labor pain, patient satisfaction
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario Fundación Santa Fe
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Continuous Epidural Infusion
Programmed Intermittent Epidural Bolus
Arm Description
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. A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
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. A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered .
Outcomes
Primary Outcome Measures
Pain level in laboring women measured by the Numeric Analog Scale
to compare pain level in each arm once epidural analgesia is applied until birth
Secondary Outcome Measures
Full Information
NCT ID
NCT02510287
First Posted
July 22, 2015
Last Updated
May 19, 2016
Sponsor
Fundación Santa Fe de Bogota
1. Study Identification
Unique Protocol Identification Number
NCT02510287
Brief Title
A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Santa Fe de Bogota
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
analgesia, epidural, labor pain, patient satisfaction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Epidural Infusion
Arm Type
Active Comparator
Arm Description
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.
A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered.
Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
Arm Title
Programmed Intermittent Epidural Bolus
Arm Type
Experimental
Arm Description
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.
A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour.
Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered .
Intervention Type
Drug
Intervention Name(s)
Bupivacaine and Fentanyl Initial Dose
Intervention Description
10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine and Fentanyl: Continuous Epidural Infusion
Intervention Description
0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus
Intervention Description
A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour
Intervention Type
Drug
Intervention Name(s)
Rescue Bolus
Intervention Description
Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
Primary Outcome Measure Information:
Title
Pain level in laboring women measured by the Numeric Analog Scale
Description
to compare pain level in each arm once epidural analgesia is applied until birth
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Universitario Fundación Santa Fe
City
Bogota
Country
Colombia
12. IPD Sharing Statement
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A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses
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