Trials / Completed
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
| Type | Name | Description |
|---|---|---|
| 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. |
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.