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

NCT02510287 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2016-05-20

No results posted yet for this study

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

Interventions

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

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

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.

Sponsors & Collaborators

  • Fundación Santa Fe de Bogota

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02510287 on ClinicalTrials.gov