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

Fundación Santa Fe de Bogota

Status: Completed

Conditions: Labor Pain

Treatments: Drug: Bupivacaine and Fentanyl: Continuous Epidural Infusion; Drug: Rescue Bolus; Drug: Bupivacaine and Fentanyl Initial Dose; Drug: Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02510287

CCEI-3413-2015

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Continuous Epidural Infusion

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine

Drug: Rescue Bolus

Drug: Bupivacaine and Fentanyl: Continuous Epidural Infusion

Drug: Bupivacaine and Fentanyl Initial Dose

Programmed Intermittent Epidural Bolus

Experimental group

Description:

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 .

Treatment:

Drug: Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus

Drug: Lidocaine

Drug: Rescue Bolus

Drug: Bupivacaine and Fentanyl Initial Dose