Intermittent Automated Devices for Labor Analgesia in Emilia Romagna

University of Modena and Reggio Emilia671 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

671

Conditions

Labor Pain

Interventions

Programmed Intermittent bolusDEVICE

Programmed epidural bolus of 10 ml mixture every 75 minutes, plus patient controlled bolus of 5 ml same mixture; lock-out 15 minutes.

Manual epidural bolusOTHER

Epidural bolus of 15 ml levobupivacaine and sufentanyl 10 mcg or 5 mcg administered by anesthesist on maternal request.

LevobupivacaineDRUG

Levobupivacaine 0,0625% through peridural catheter

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Ospedale Ramazzini di Carpi

Carpi, MO, Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, Italy

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, Italy

Outcomes

Primary Outcomes

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.

Time frame: Through labor completion