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

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: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Bupivacaine and Fentanyl Initial Dose; Drug: Bupivacaine and Fentanyl: Continuous Epidural Infusion; Drug: Rescue Bolus; Drug: Lidocaine; Drug: Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Continuous Epidural Infusion; 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.	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; 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 .	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

Outcome Measure	Measure Description	Time Frame
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	one year

Collaborators and Investigators

• Sponsor: Fundación Santa Fe de Bogota

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (ESTIMATE): July 29, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: patient satisfaction; labor pain; analgesia, epidural
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Fentanyl; Lidocaine; Bupivacaine
• Other Study ID Numbers: CCEI-3413-2015