Intermittent Automated Devices for Labor Analgesia in Emilia Romagna

Not Applicable

Terminated

• Conditions: Labor Pain
• Interventions: Device: Programmed Intermittent bolus; Other: Manual epidural bolus; Drug: Levobupivacaine; Drug: Sufentanil 4 mcg; Drug: Sufentanil 5 mcg

• Registration Number: NCT02710877
• Lead Sponsor: University of Modena and Reggio Emilia

Brief 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.

Study Timeline

• Study Start: 2014-12-23
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-17
• Primary Completion: 2017-12-27
• Study Completion: 2018-02-28
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-25
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 671

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Programmed Intermittent bolus (PIEB)	Sufentanil 4 mcg	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.
Programmed Intermittent bolus (PIEB)	Programmed Intermittent bolus	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.
Manuale epidural bolus (TOP-UP)	Sufentanil 5 mcg	Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request.
Manuale epidural bolus (TOP-UP)	Manual epidural bolus	Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request.
Programmed Intermittent bolus (PIEB)	Levobupivacaine	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.
Manuale epidural bolus (TOP-UP)	Levobupivacaine	Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request.

Primary Outcome Measures

Name	Time	Method
Rate of instrumental delivery	Through labor completion	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.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Azienda Ospedaliero-Universitaria Policlinico di Modena; 🇮🇹 Modena, Italy

Azienda Ospedaliero-Universitaria di Parma; 🇮🇹 Parma, PR, Italy

Ospedale Ramazzini di Carpi; 🇮🇹 Carpi, MO, Italy