Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor

Study Overview
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Brief Summary
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Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered with a pump that could only provide continuous infusion of the freezing medication in combination of pushes of medication activated by the patient, a technique called patient controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested that this continuous infusion of medication is not as effective as previously thought, and suggested that instead of continuous infusion, intermittent programmed pushes should be used. The investigators now have devices that are able to do that. Programmed intermittent epidural bolus (PIEB) is a new technological advance based on the concept that boluses of freezing medication in the epidural space are superior to continuous epidural infusion (CEI). The new pumps are able to deliver bolus of medication at regular intervals (PIEB), in addition to what the patient can deliver herself (PCEA). Studies have shown that delivering analgesia in this manner can prolong the duration of analgesia, diminish motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption. Based on the information already available in the literature, this study aims to determine the best regimen of PIEB achievable with our standard epidural mixture. The hypothesis of this study is that there is an optimal interval time between PIEB boluses of 30 to 60 minutes at a fixed volume of 10 ml of our standard epidural mixture that will provide women the necessary drug requirements, thus avoiding breakthrough pain and need for PCEA or physician intervention.

Detailed Description
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All studies involving PIEB to date have provided an analgesic regimen that delivered an amount of local anesthetic that was below the patient's requirement per hour, as the studies were done in the context of an association with PCEA (Patient controlled epidural anesthesia) as a rescue technique. As a result, PCEA requests were frequent and therefore these studies have not been able to truly understand the pharmacology of the bolus technique in the PIEB regimen, as the PCEA utilized by patients added an extra component to the regimen. The ideal volume and interval time between PIEB bolus has not yet been established in the literature. Most likely the ideal volume and interval time between PIEB bolus will be specific for each epidural mixture. At Mount Sinai Hospital, PIEB devices have been recently introduced. Currently our standard epidural mixture is bupivacaine 0.0625% with fentanyl 2mcg/ml. Our current epidural regimen consists of 10 ml continuous infusion per hour, with PCEA boluses of 5 ml and a lock out interval of 10 minutes, for a maximum of 20 ml of the epidural mixture per hour. In this study, the investigators will offer patients 10mL PIEBs of bupivacaine 0.0625% with fentanyl 2mcg/ml at 4 different intervals. PCEA bolus of 5mL of the same solution will also be available. The goal is to establish the ideal PIEB regimen that will be effective for our patient population with our standard epidural mixture. Finding the best way of using the new device that will be able to provide analgesia for 90% of the parturients will represent a great improvement in labor analgesia. Moreover, there are expectations of having fewer side effects since the PIEB is more effective than CEI.

Official Title
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Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 10 ml of Bupivacaine 0.0625% Plus Fentanyl 2 mcg/ml.

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Fentanyl
* Device: Infusion pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I or II Full term (≥ 37 weeks gestation) nulliparous Singleton pregnancy, vertex presentation Regular painful contractions occurring at least every 5 minutes VAS Pain score at requesting analgesia > 5 (VNPS 0-10) Cervical dilatation < 5 cm Exclusion Criteria: Refusal to provide written informed consent. Any contraindication to epidural anesthesia Accidental dural puncture Allergy or hypersensitivity to bupivacaine or fentanyl Use of opioids or sedatives within the last 4 hours.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 60 minutes<br>The infusion pump will deliver programmed intermittent epidural boluses at a 60-minute interval. The bolus will consist of 10mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available. | Drug: Bupivacaine<br>* 0.0625% Bupivacaine plus fentanyl 2mcg/ml<br>* Other names: Marcaine;Drug: Fentanyl<br>* 0.0625% Bupivacaine plus fentanyl 2mcg/ml<br>Device: Infusion pump<br>* Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).<br>* Other names: CADD-Solis Ambulatory Infusion Pump;|
| Experimental: 50 minutes<br>The infusion pump will deliver programmed intermittent epidural boluses at a 50-minute interval. The bolus will consist of 10mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available. | Drug: Bupivacaine<br>* 0.0625% Bupivacaine plus fentanyl 2mcg/ml<br>* Other names: Marcaine;Drug: Fentanyl<br>* 0.0625% Bupivacaine plus fentanyl 2mcg/ml<br>Device: Infusion pump<br>* Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).<br>* Other names: CADD-Solis Ambulatory Infusion Pump;|
| Experimental: 40 minutes<br>The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 10mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available. | Drug: Bupivacaine<br>* 0.0625% Bupivacaine plus fentanyl 2mcg/ml<br>* Other names: Marcaine;Drug: Fentanyl<br>* 0.0625% Bupivacaine plus fentanyl 2mcg/ml<br>Device: Infusion pump<br>* Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).<br>* Other names: CADD-Solis Ambulatory Infusion Pump;|
| Experimental: 30 minutes<br>The infusion pump will deliver programmed intermittent epidural boluses at a 30-minute interval. The bolus will consist of 10mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available. | Drug: Bupivacaine<br>* 0.0625% Bupivacaine plus fentanyl 2mcg/ml<br>* Other names: Marcaine;Drug: Fentanyl<br>* 0.0625% Bupivacaine plus fentanyl 2mcg/ml<br>Device: Infusion pump<br>* Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).<br>* Other names: CADD-Solis Ambulatory Infusion Pump;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No request for supplemental analgesia | No request for supplemental analgesia (PCEA bolus or clinician administered bolus) until the completion of the first stage of labor or until 6 hours following initiation of the programmed intermittent epidural bolus (PIEB). | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block level | Sensory block to ice will be assessed bilaterally at the mid axillary lines, and the level of block will be the level at which the patient still does not feel cold sensation as compared to a control site (frontal part of the head) | 6 hours | 
| Motor block level assessed using Bromage score | Motor block will be assessed with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle. | 6 hours | 
| Hypotension | A decrease in systolic blood pressure greater than 20% from baseline (defined as an average of 3 readings prior to epidural). | 6 hours | 
| Pain score | Pain score measured hourly using VNRS (0-10) | 6 hours | 

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