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

NCT02510287 | Completed

• 1 other identifier: CCEI-3413-2015
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

analgesia, epidural; labor pain; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Continuous Epidural Infusion

ACTIVE COMPARATOR

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; Drug: Bupivacaine and Fentanyl: Continuous Epidural Infusion; Drug: Rescue Bolus; Drug: Lidocaine

Programmed Intermittent Epidural Bolus

EXPERIMENTAL

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; Drug: Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus; Drug: Rescue Bolus; Drug: Lidocaine

Interventions

Bupivacaine and Fentanyl Initial Dose DRUG

10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution)

Continuous Epidural Infusion; Programmed Intermittent Epidural Bolus

Bupivacaine and Fentanyl: Continuous Epidural Infusion DRUG

0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour)

Continuous Epidural Infusion

Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus DRUG

A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour

Programmed Intermittent Epidural Bolus

Rescue Bolus DRUG

Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.

Continuous Epidural Infusion; Programmed Intermittent Epidural Bolus

Lidocaine DRUG

If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.

Continuous Epidural Infusion; Programmed Intermittent Epidural Bolus

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At term pregnancy
• Laboring patients requiring epidural analgesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

Study Sites (1)

Hospital Universitario Fundación Santa Fe

Bogotá, Bogota D.C., Colombia

Location

MeSH Terms

Conditions

Labor Pain; Agnosia; Patient Satisfaction

Interventions

Bupivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD anesthesiologist

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 29, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

CO (1)