Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients

Study Overview
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Brief Summary
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To test the efficacy of different recipes of epidural infusions used for providing pain relief during labor in parturients.

Detailed Description
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In this prospective trial, the investigators would like to examine the efficacy of several different PCEA protocols in 250 parturients who receive CSE for labor pain. Any patient with failed epidural, delivery within 2 hours of epidural insertion, or Cesarean section will be excluded from the study. Each patient will be assigned to one of five groups (A - E), depending on the day of admission for delivery, excluding Friday and Saturday (observed religious holidays). Each group will have 50 patients.

Official Title
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Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients Receiving Combined Spinal and Epidural Analgesia (CSE)

Conditions
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LABOR PAIN

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parturients receiving Combined Spinal epidural analgesia for labor pain relief. Exclusion Criteria: Any patient with failed epidural, delivery within 2 hours of epidural insertion, or Cesarean section will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GROUP A<br>The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 8ml Lockout ( number of doses per hour) 2 Lock out interval 30 minutes | |
| GROUP B<br>The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 5ml Lockout ( number of doses per hour) 4 Lock out interval 15 minutes | |
| GROUP C<br>The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 3ml Lockout ( number of doses per hour) 6 Lock out interval 10 minutes | |
| GROUP D<br>The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 14 ml/hour Demand dose 0 ml Lockout ( number of doses per hour) 0 Lock out interval 0 minutes | |
| GROUP E<br>The PCEA solution will contain 0.1% Bupivacaine + 2.85 mcg/cc of Fentanyl. Basal infusion 7 ml/hour Demand dose 7ml Lockout ( number of doses per hour) 3 Lock out interval 20 minutes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | From each patient investigators will collect pain scores to assess the severity of labor pain, using the Visual Analog Scale (VAS) scale, 1-10. VAS score of 1 is considered minimal pain and VAS score of 10 is considered as the maximum pain. | 24 to 48 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of boluses | From each patient the investigators will obtain information on total number of boluses of the epidural medication used | 24 to 48 hours | 
| Amount of medication used | From each patient the investigators will obtain information regarding the total amount of medications used in mls from reviewing the history on the PCEA pump. | 24 to 48 hours | 
| Motor block | For each patient, the investigators will obtain information regarding degree of motor block using the Modified Bromage scale. Modified Bromage score: Complete block (unable to move feet or knees) Almost complete block (able to move feet only) Partial block (just able to move knees) Detectable weakness of hip flexion while supine (full flexion of knees) No detectable weakness of hip flexion while supine Able to perform partial knee bend | 24 to 48 hours. | 
| Height of the patient | From each patient the investigators will obtain information on height in inches. | At recruitment of the patient in to the study | 
| Weight of the patient | From each patient the investigators will obtain information on weight in pounds | At recruitment of the patient in to the study | 
| Overall patient satisfaction | From each patient investigators will collect satisfaction scores to assess degree of satisfaction, using the Visual Analog Scale (VAS) scale, 1-10. VAS score of 1 is considered minimal satisfaction and VAS score of 10 is considered as the maximum satisfaction. | 24 to 48 hours | 
| Mode of delivery | From each patient the investigators will obtain information regarding mode of delivery- vaginal delivery or C-Section | 24 to 48 hours |