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

Study Overview
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Brief Summary
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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
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Labor Pain

Intervention / Treatment
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* Drug: Bupivacaine and Fentanyl Initial Dose
* Drug: Bupivacaine and Fentanyl: Continuous Epidural Infusion
* Drug: Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus
* Drug: Rescue Bolus
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Epidural Infusion<br>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. A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered. | Drug: Bupivacaine and Fentanyl Initial Dose<br>* 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution)<br>Drug: Bupivacaine and Fentanyl: Continuous Epidural Infusion<br>* 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour)<br>Drug: Rescue Bolus<br>* Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.<br>Drug: Lidocaine<br>* If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.<br>|
| Experimental: Programmed Intermittent Epidural Bolus<br>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. A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered . | Drug: Bupivacaine and Fentanyl Initial Dose<br>* 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution)<br>Drug: Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus<br>* A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour<br>Drug: Rescue Bolus<br>* Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.<br>Drug: Lidocaine<br>* If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, epidural, labor pain, patient satisfaction