Intermittent Automated Devices for Labor Analgesia in Emilia Romagna (PA-RER)

University of Modena and Reggio Emilia

Status: Terminated

Conditions: Labor Pain

Treatments: Device: Programmed Intermittent bolus; Drug: Sufentanil 4 mcg; Other: Manual epidural bolus; Drug: Levobupivacaine; Drug: Sufentanil 5 mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT02710877

CE 274/13

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 671 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Nulliparous women at full-term pregnancy single fetus and vertex presentation, hospitalized for harbingers of labor and cervical dilation less than 5 cm
2. Numeric Rate Scale > 5

Exclusion criteria

1. patients aged under 18 years
2. patients with ongoing administration of oxytocin
3. patients with no indications to epidural analgesia
4. patients with inability to place the epidural catheter for technical difficulty
5. patients with parenteral administration of opioids
6. multiparous women
7. patients unable to understand the objectives and procedures of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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671 participants in 2 patient groups

Programmed Intermittent bolus (PIEB)

Experimental group

Description:

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.

Treatment:

Drug: Levobupivacaine

Drug: Sufentanil 4 mcg

Device: Programmed Intermittent bolus

Manuale epidural bolus (TOP-UP)

Active Comparator group

Description:

Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request.

Treatment:

Drug: Sufentanil 5 mcg

Drug: Levobupivacaine

Other: Manual epidural bolus