NCT02710877

Intermittent Automated Devices for Labor Analgesia in Emilia Romagna

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 671 (actual)
• Sponsor: University of Modena and Reggio Emilia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Labor Pain

Interventions

Type	Name	Description
DEVICE	Programmed Intermittent bolus	Programmed epidural bolus of 10 ml mixture every 75 minutes, plus patient controlled bolus of 5 ml same mixture; lock-out 15 minutes.
OTHER	Manual epidural bolus	Epidural bolus of 15 ml levobupivacaine and sufentanyl 10 mcg or 5 mcg administered by anesthesist on maternal request.
DRUG	Levobupivacaine	Levobupivacaine 0,0625% through peridural catheter
DRUG	Sufentanil 4 mcg	Sufentanil 0,4 mcg/ml through peridural catheter
DRUG	Sufentanil 5 mcg	Sufentanil 5 mcg through peridural catheter

Timeline

• Start date: 2014-12-23
• Primary completion: 2017-12-27
• Completion: 2018-02-28
• First posted: 2016-03-17
• Last updated: 2018-03-27

Locations

3 sites across 1 country: Italy