Intermittent Ropivacaine Bolus for Epidural Labor Analgesia

Study Overview
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Brief Summary
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Enhanced patient safety and satisfaction have contributed to growing use of epidural labor analgesia. Epidural analgesia appears to be currently the most effective technique in reducing pain during labor. However, reduction in total dose of local anesthetic and thus motor blockade is crucial to improve the obstetric outcome. This technique has evolved from intermittent boluses by anesthesiologists to the current standard labor epidural analgesic regimens in many institutions in North America and Europe that consist of a local anesthetic in combination with an opioid delivered via continuous epidural infusion (CEI) with or without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of administration has been used: regular bolus of low concentration local anesthetic + intermittent bolus (PIEB). This technique would offer safe and superior quality labor analgesia and greater maternal satisfaction by reducing total amount of the drug combination. The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes, total drug dose and incidence of pain that required top-up administration (breakthrough pain)

Detailed Description
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Patients were explained about the procedure and written informed consent was obtained. Healthy term primi or second gravid parturients (aged >18 years) with a singleton, live fetus in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm were recruited in the study after they requested epidural for pain relief. PIEB epidural analgesia was used. Primary outcome was maternal satisfaction during labor and delivery. Our hypothesis was that patients would have a greater level of satisfaction when using PIEB technique. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes.

Official Title
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Intermittent Bolus Administration of Ropivacaine for Epidural Labor Analgesia : an Observational Study

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy term primi or second gravid parturients aged 18-30 years singleton, live fetus vertex presentation active stage of labor with cervical dilation of 3-5 cm parturients Exclusion Criteria: Hypertension no vertex presentation contraindications to neuraxial blockade

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Epidural group<br>Epidural : automatic intermittent boluses ( 8-12 mL per hour) + patient controlled bolus (4 mL evrey 20 min) using ropivacaine | Drug: Ropivacaine<br>* Epidural : automatic intermittent boluses associated with patient controlled bolus using ropivacaine<br>* Other names: ropivacaine 2 mg/ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Analogue Satisfaction Score | VASS: 0-10: 0 = no satisfaction to 10 (total satisfaction) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal hypotension | Evaluation of adverse events over epidural infusion (mean arterial pressure< 65 mmHg) | 1 day | 
| Apgar score | The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's: Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. | 1 day | 
| Anesthetic rescue | Evaluation of the rescue performed by anesthesist over infusion | 1 day | 
| nausea | Number of maternal nausea event | 1 day | 
| fetal heart rate | Fetal heart sounds were monitored with a continuous Doppler machine | 1 day | 
| Motor blockade | Bromage score for maternal motor block | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnant, Labor, Epidural, Analgesia, Intermittent