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

Labor Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510287
• Other study ID #: CCEI-3413-2015
• Status: Completed
• Phase: N/A
• First received: July 22, 2015
• Last updated: May 19, 2016
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Fundación Santa Fe de Bogota
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Labor Pain

Intervention

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)
• Bupivacaine and Fentanyl: Continuous Epidural Infusion
0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour)
• 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
• Rescue Bolus
Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
• 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.

Locations

Country	Name	City	State
Colombia	Hospital Universitario Fundación Santa Fe	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Santa Fe de Bogota

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No