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

NCT ID: NCT02510287

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-05-31

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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Continuous Epidural Infusion

1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.

2. A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered.

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

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine and Fentanyl Initial Dose

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Rescue Bolus

Intervention Type: DRUG

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

Lidocaine

Intervention Type: DRUG

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

Programmed Intermittent Epidural Bolus

1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.

2. A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour.

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

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

Group Type: EXPERIMENTAL

Bupivacaine and Fentanyl Initial Dose

Intervention Type: DRUG

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: Programmed Intermittent Epidural Bolus

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Lidocaine

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Bupivacaine and Fentanyl: Continuous Epidural Infusion

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

Intervention Type: 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

Intervention Type: DRUG

Rescue Bolus

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación Santa Fe de Bogota

OTHER

Sponsor Role: lead

Responsible Party

Leopoldo Ferrer

MD anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Fundación Santa Fe

Bogotá, Bogota D.C., Colombia

Countries

Colombia

Other Identifiers

CCEI-3413-2015

Identifier Type: -

Identifier Source: org_study_id