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

March 25, 2018 updated by: Laura Rinaldi, University of Modena and Reggio Emilia

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

671

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41100
        • Azienda Ospedaliero-Universitaria Policlinico di Modena
    • MO
      • Carpi, MO, Italy
        • Ospedale Ramazzini di Carpi
    • PR
      • Parma, PR, Italy
        • Azienda Ospedaliero-Universitaria di Parma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of instrumental delivery
Time Frame: 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.
Through labor completion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Investigators

  • Study Director: Massimo Girardis, PhD, University of Modena and Reggio Emilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2014

Primary Completion (Actual)

December 27, 2017

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 25, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 274/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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