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CompletedNCT02510287

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
128 (actual)
Sponsor
Fundación Santa Fe de Bogota · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGBupivacaine and Fentanyl Initial Dose10 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 Infusion0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour)
DRUGBupivacaine and Fentanyl: Programmed Intermittent Epidural BolusA 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour
DRUGRescue BolusUpon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
DRUGLidocaineIf needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.

Timeline

Start date
2015-07-01
Primary completion
2016-05-01
Completion
2016-05-01
First posted
2015-07-29
Last updated
2016-05-20

Locations

1 site across 1 country: Colombia

Source: ClinicalTrials.gov record NCT02510287. Inclusion in this directory is not an endorsement.

A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses (NCT02510287) · Clinical Trials Directory