Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

Study Overview
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Brief Summary
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Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia.

Detailed Description
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The optimal PIEB and patient controlled epidural administered (PCEA) bolus settings are still unknown. Therefore, in this study, the investigators aim to compare analgesia outcomes both high and low PIEB flow rate settings.

Official Title
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Effect of Programmed Intermittent Epidural Bolus Delivery Rate on the Quality of Labour Analgesia: A Randomized Clinical Trial

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Bupivacaine 0.08% - fentanyl 2mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton, vertex presentations at term (37-42 weeks gestational age) </= 5cm cervical dilation at the time of epidural anesthesia request ASA 2-3 patients aged 19 or over who are able to provide informed consent Exclusion Criteria: Contraindications to neuraxial analgesia or risk factors likely to affect placement or function of the epidural History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids Current or historical evidence of any significant medical conditions Clinical settings in which continuous epidural infusion may be preferable Risk factors significantly increasing the need for Cesarean delivery Anticipated fetal abnormalities

Ages Eligible for Study
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Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings: PIEB flow rate = high; interval = 60 min | Drug: Bupivacaine 0.08% - fentanyl 2mcg<br>* In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.<br>|
| Experimental: Group B<br>Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min | Drug: Bupivacaine 0.08% - fentanyl 2mcg<br>* In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.<br>|
| Experimental: Group C<br>Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min | Drug: Bupivacaine 0.08% - fentanyl 2mcg<br>* In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breakthrough pain | Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain | Duration of labor with epidural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor analgesia, Programmed intermittent epidural bolus