Intermittent Automated Devices for Labor Analgesia in Emilia Romagna

Study Overview
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Brief Summary
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The study aims to determine whether the use of automated intermittent devices for labor analgesia could prevent the increase of instrumental deliveries, with same analgesia. Moreover it will evaluate if automated devices can allow a reduction of health-care burden.

Detailed Description
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Epidural analgesia is recognized as the most effective technique to control labor pain, although its possible adverse events. Continuous epidural administration of local anesthetics can stabilize the analgesic block and reduce the anesthesiologists' workload but is associated with an increase in operative vaginal delivery. Epidural intermittent boluses performed by anesthetist are associated to reduction of dosages, but they could provide insufficient analgesia and they involve the constant anesthetist's presence in the operating room. This is a multicenter randomized controlled trial with two arms, funded by grant of Regione Emilia Romagna, in which we will compare two different epidural analgesia protocols: anesthesiologist's supervised versus intermittent boluses with PCEA.

Official Title
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Pain Management During Labor: Use of Intermittent Drug Delivery Devices for Obstetric and Neonatal Outcome Improvement and Health-care Burden Reduction

Conditions
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Labor Pain

Intervention / Treatment
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* Device: Programmed Intermittent bolus
* Other: Manual epidural bolus
* Drug: Levobupivacaine
* Drug: Sufentanil 4 mcg
* Drug: Sufentanil 5 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous women at full-term pregnancy single fetus and vertex presentation, hospitalized for harbingers of labor and cervical dilation less than 5 cm Numeric Rate Scale > 5 Exclusion Criteria: patients aged under 18 years patients with ongoing administration of oxytocin patients with no indications to epidural analgesia patients with inability to place the epidural catheter for technical difficulty patients with parenteral administration of opioids multiparous women patients unable to understand the objectives and procedures of the study

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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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Programmed Intermittent bolus (PIEB)<br>Intervention: epidural analgesia through administration of a mixture of levobupivacaine 0,0625% and sufentanil 4 mcg. Intermittent bolus of 10 ml mixture every 75 minutes. Patient controlled bolus of 5 ml same mixture, lock-out 15 minutes. | Device: Programmed Intermittent bolus<br>* Programmed epidural bolus of 10 ml mixture every 75 minutes, plus patient controlled bolus of 5 ml same mixture; lock-out 15 minutes.<br>* Other names: PIEB;Drug: Levobupivacaine<br>* Levobupivacaine 0,0625% through peridural catheter<br>* Other names: CHIROCAINE;Drug: Sufentanil 4 mcg<br>* Sufentanil 0,4 mcg/ml through peridural catheter<br>* Other names: FENTATIENIL;|
| Active Comparator: Manuale epidural bolus (TOP-UP)<br>Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request. | Other: Manual epidural bolus<br>* Epidural bolus of 15 ml levobupivacaine and sufentanyl 10 mcg or 5 mcg administered by anesthesist on maternal request.<br>* Other names: TOP-UP;Drug: Levobupivacaine<br>* Levobupivacaine 0,0625% through peridural catheter<br>* Other names: CHIROCAINE;Drug: Sufentanil 5 mcg<br>* Sufentanil 5 mcg through peridural catheter<br>* Other names: FENTATIENIL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of instrumental delivery | Vaginal delivery obtained through vacuum device intervention decided independently by the obstetrician on duty, according to defined local protocols and according to the conditions of the mother and fetus. | Through labor completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate analgesia | Mean Numeric Rate Scale values < 5 through labor analgesia | Labor length since peridural catheter insertion until delivery | 
| Total amount of local anesthetic | Total amount of levobupivacaine (mg) | Labor length since peridural catheter insertion until delivery | 
| Time-related amount of local anesthetic | Amount of levobupivacaine for minute of analgesia (mg/min) | Labor length since peridural catheter insertion until delivery | 
| Motor block episodes | Number of patients with motor block episodes, defined by modified Bromage score >1 | Labor length since peridural catheter insertion until delivery | 
| Anesthesiologist working time | Total time spent in labor room by anesthesiologist (minutes) | Labor length since peridural catheter insertion until delivery | 
| Health economic assessment | Total epidural analgesia charge | Labor length since peridural catheter insertion until delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural analgesia, patient controlled analgesia, obstetric outcome