Epidural Loading Prior to Catheter Insertion

Study Overview
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Brief Summary
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This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists.

Detailed Description
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This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists. Investigators propose to conduct a single blinded, randomized controlled trial to determine if a difference exists in the speed of onset and spread of labor analgesia between patients receiving an epidural loading dose through the epidural needle or catheter. Group 1 (Epidural Catheter Administration) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement (current standard practice). Group 2 (Epidural Needle Administration ) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement (experimental group). Various parameters will be measured in the time after drug administration to evaluate blood pressure, heart rate, and fetal heart rate. Following delivery, the total anesthetic dose, total number of doses demanded, total number and dosage of rescue doses, and overall patient satisfaction will be recorded.

Official Title
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Epidural Loading Prior to Catheter Insertion: An Alternative to the Combined Spinal-epidural Technique?

Conditions
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Administration Methods of Labor Analgesia

Intervention / Treatment
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* Procedure: Epidural loading dose
* Device: Epidural catheter
* Device: Epidural needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects who have volunteered and consented to participation in the study upon admission to labor and delivery parturients in active labor requesting epidural analgesia uncomplicated pregnancy with a reassuring fetal heart tracing age≥18 years Exclusion Criteria: contraindication to epidural anesthesia inability to read, comprehend, and sign the informed consent form fetal intrauterine growth retardation (IUGR) non-reassuring fetal heart tracing cervical dilation greater than 7cm intra-uterine fetal demise any spinal pathology or neurologic disease history of chronic pain incarcerated patients any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (>3 attempts, presence of CSF).

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural Catheter Administration<br>Participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement. (Current standard practice) Epidural loading dose via epidural catheter. | Procedure: Epidural loading dose<br>* Labor epidural analgesia loading dose<br>Device: Epidural catheter<br>* Epidural loading dose via epidural catheter<br>|
| Experimental: Epidural Needle Administration<br>Participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement. Epidural loading dose via epidural needle. | Procedure: Epidural loading dose<br>* Labor epidural analgesia loading dose<br>Device: Epidural needle<br>* Epidural loading dose via epidural needle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean VAS pain score | Mean VAS pain score will be determined 20 minutes following epidural loading, including assessments at 5, 10, 15, and 20 minutes. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic level | Analgesic level assessed by pinprick at 10, 15 and 20 minutes following loading | 10, 15, and 20 minutes | 
| Maternal Blood Pressure | Change in maternal blood pressure loading | Baseline and 20 minutes | 
| Fetal Heart Rate | Change in fetal heart rate over 20 minutes following loading | Baseline and 20 minutes | 
| Rescue Bolus Count | Number of rescue bolus doses will be counted | During Labor | 
| Analgesia Satisfaction | Overall patient satisfaction with analgesia following delivery via questionnaire | During labor | 
| Intravascular catheter placement | Incidence of intravascular catheter placement | During labor | 
| Total anesthetic dose required | The total anesthetic dose during labor will be calculated | During Labor | 
| Maternal Heart Rate | Change in maternal heart rate | Baseline and 20 minutes |