Epidural Loading: High Volume, Low Concentration

Study Overview
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Brief Summary
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This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter.

Detailed Description
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This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter. Control patients will receive local anesthetic in lower volume more concentrated solution via the epidural catheter which is current standard practice. Outcome measures will include quantifying pain relief with respect to time using VAS scores. In addition, post delivery patient satisfaction regarding anesthesia regimen, blood pressure changes, heart rate, anesthetic level, total dose of epidural used during labor, rescue doses and incidence of fetal bradycardia will be assessed. 35 patients will be recruited for each of the three arms of the study, totaling 105 patients, in order to obtain significance when performing statistical analyses following complete enrollment in the study. The impetus of this study involves investigation of the effects of loading the epidural space with high volume, low concentration local anesthetic via two different modalities and studying which method is more efficacious.

Official Title
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Epidural Loading With High Volume, Low Concentration Prior to Catheter Insertion: is How You Administer the Volume Important?

Conditions
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Labor and Delivery

Intervention / Treatment
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* Procedure: Epidural needle
* Procedure: Catheter Administration
* Procedure: Standard of Care Epidural Administration


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 greater than or equal to 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 History of chronic pain other than in the back Incarcerated patients I. Any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (>3 attempts, presence of CSF) j. Any evidence of high spinal after initial bolus or continuous infusion of high volume, low concentration local anesthetic solution k. Women undergoing cesarean section

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Volume, Low Concentration via Epidural Needle<br>Epidural loading: Participants will receive 20ml of 0.0625% bupivacaine with fentanyl 1mcg/ml epidural loading dose in 10ml increments five minutes apart via epidural needle followed by catheter placement. For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.03125% bupivacaine with 1mcg/ml fentanyl. The infusion rate will be set at 20ml/hr basal rate and 8ml every 15 minutes on demand with lockout of 52ml/hr. For inadequate analgesia: One additional 10ml boluses of the experimental 0.0625% bupivacaine with 1mcg/ml will be provided spaced 5 minutes apart via the epidural catheter. | Procedure: Epidural needle<br>* Medication administration via epidural needle.<br>|
| Experimental: High Volume, Low Concentration via Epidural Catheter<br>Epidural loading: Participants will receive 20ml of 0.0625% bupivacaine with fentanyl 1mcg/ml epidural loading dose in 10ml increments five minutes apart via the epidural catheter administration following catheter placement. For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.03125% bupivacaine with 1mcg/ml fentanyl. The infusion rate will be set at 20ml/hr basal rate and 8ml every 15 minutes on demand with lockout of 52ml/hr. For inadequate analgesia: One additional 10ml boluses of the experimental 0.0625% bupivacaine with 1mcg/ml will be provided spaced 5 minutes apart via the epidural catheter. | Procedure: Catheter Administration<br>* Medication administration via epidural catheter.<br>|
| Active Comparator: Low Volume, High Concentration via Epidural Catheter<br>Standard of Care Epidural Administration Epidural loading: Participants will receive 10ml of 0.125% bupivacaine with fentanyl 2mcg/ml in 5 ml increments 5 minutes apart via the epidural catheter following epidural catheter placement, per standard of care. For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.0625% bupivacaine with 2mcg/ml fentanyl. The infusion rate will be set at 10ml/hr basal rate and 4ml every 15 minutes on demand with lockout of 26ml/hr. For inadequate analgesia: One additional 5ml boluses of the standard 0.125% bupivacaine with 2mcg/ml will be provided spaced 5 minutes apart via the epidural catheter. | Procedure: Standard of Care Epidural Administration<br>* Medication administered at higher concentration, lower volume via epidural catheter.<br>* Other names: Epidural catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Pain Levels (VAS Assessment) | Patients will be assessed for pain levels on the VAS scale after analgesia administration in both arms | During Labor | 
| Patient Satisfaction | Patient satisfaction with analgesia using a Likert rating of patient satisfaction with anesthetic care. | During labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic level | Pinprick every 10, 15, and 20 minutes following loading | 20 minutes | 
| Maternal Vital Signs | Measure change in maternal blood pressure and heart rate over 20 minutes following loading. | 20 minutes | 
| Fetal Heart Rate | Measure change in fetal heart rate following loading. | 20 minutes | 
| Rescue Bolus | Measure number of rescue bolus doses and total anesthetic dose | During Labor | 
| Intravascular Catheter Placement | Measure incidence of intravascular catheter placement. | During labor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Effects of; Anesthesia, spinal and epidural