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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02510287

Enrollment

128

Registered

2015-07-29

Start date

2015-07-31

Completion date

2016-05-31

Last updated

2016-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

analgesia, epidural, labor pain, patient satisfaction

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.

Interventions

DRUGBupivacaine 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)

DRUGBupivacaine and Fentanyl: Continuous Epidural Infusion

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

DRUGBupivacaine 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

DRUGRescue Bolus

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

DRUGLidocaine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pain level in laboring women measured by the Numeric Analog Scale	one year	to compare pain level in each arm once epidural analgesia is applied until birth

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026