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Labor PainPA-RERNCT02710877

Intermittent Automated Devices for Labor Analgesia in Emilia Romagna

A study testing Programmed Intermittent bolus, Manual epidural bolus and Levobupivacaine in people with Labor Pain, run by University of Modena and Reggio Emilia at 3 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Labor Pain
What is being tested?
Programmed Intermittent bolus, Manual epidural bolus and Levobupivacaine
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
671 participants
Where
3 sitesItaly
Study dates
23 Dec 2014to 28 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • patients aged under 18 years
  • patients with ongoing administration of oxytocin
  • patients with no indications to epidural analgesia
  • patients with inability to place the epidural catheter for technical difficulty
  • patients with parenteral administration of opioids
  • multiparous women
  • patients unable to understand the objectives and procedures of the study

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • Ospedale Ramazzini di Carpi

    Carpi, MO

  • Azienda Ospedaliero-Universitaria Policlinico di Modena

    Modena, 41100

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, PR

Other trials in Italy

About this study

Official title: 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.

Read the 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
Being tested
Programmed Intermittent bolus, Manual epidural bolus, Levobupivacaine, Sufentanil 4 mcg, Sufentanil 5 mcg
Keywords
epidural analgesia, patient controlled analgesia, obstetric outcome
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Programmed Intermittent bolusDevice

    Also called PIEB

    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

    Also called TOP-UP

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

  • LevobupivacaineDrug

    Also called CHIROCAINE

    Levobupivacaine 0,0625% through peridural catheter

  • Sufentanil 4 mcgDrug

    Also called FENTATIENIL

    Sufentanil 0,4 mcg/ml through peridural catheter

  • Sufentanil 5 mcgDrug

    Also called FENTATIENIL

    Sufentanil 5 mcg through peridural catheter

Study groups in NCT02710877
Study groupRoleWhat they receive
Programmed Intermittent bolus (PIEB)ExperimentalIntervention: 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.
Receives: Device: Programmed Intermittent bolus; Drug: Levobupivacaine; Drug: Sufentanil 4 mcg
Manuale epidural bolus (TOP-UP)Active comparatorIntervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request.
Receives: Other: Manual epidural bolus; Drug: Levobupivacaine; Drug: Sufentanil 5 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through labor completion

Secondary outcomes (6)

  1. Adequate analgesia

    Mean Numeric Rate Scale values < 5 through labor analgesia

    Measured: Labor length since peridural catheter insertion until delivery

  2. Total amount of local anesthetic

    Total amount of levobupivacaine (mg)

    Measured: Labor length since peridural catheter insertion until delivery

  3. Time-related amount of local anesthetic

    Amount of levobupivacaine for minute of analgesia (mg/min)

    Measured: Labor length since peridural catheter insertion until delivery

  4. Motor block episodes

    Number of patients with motor block episodes, defined by modified Bromage score >1

    Measured: Labor length since peridural catheter insertion until delivery

  5. Anesthesiologist working time

    Total time spent in labor room by anesthesiologist (minutes)

    Measured: Labor length since peridural catheter insertion until delivery

  6. Health economic assessment

    Total epidural analgesia charge

    Measured: Labor length since peridural catheter insertion until delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2016 (estimated)
  2. Study start23 Dec 2014
  3. Primary completion27 Dec 2017
  4. Study completion28 Feb 2018

Why it stopped: Stopped funding by Regional Healthcare System.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
671 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02710877
Sponsor's protocol ID
CE 274/13
Acronym
PA-RER
Status last verified
Mar 2018
First submitted
8 Mar 2016
Last updated
27 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • American College of Obstetricians and Gynecologists Committee on Obstetric Practice. ACOG committee opinion. No. 339: Analgesia and cesarean delivery rates. Obstet Gynecol. 2006 Jun;107(6):1487-8. doi: 10.1097/00006250-200606000-00060.

    PubMed 16738188

  • Anim-Somuah M, Smyth RM, Jones L. Epidural versus non-epidural or no analgesia in labour. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD000331. doi: 10.1002/14651858.CD000331.pub3.

    PubMed 22161362

  • Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.

    PubMed 22419342

  • Liu EH, Sia AT. Rates of caesarean section and instrumental vaginal delivery in nulliparous women after low concentration epidural infusions or opioid analgesia: systematic review. BMJ. 2004 Jun 12;328(7453):1410. doi: 10.1136/bmj.38097.590810.7C. Epub 2004 May 28.

    PubMed 15169744

  • Benedetto C, Marozio L, Prandi G, Roccia A, Blefari S, Fabris C. Short-term maternal and neonatal outcomes by mode of delivery. A case-controlled study. Eur J Obstet Gynecol Reprod Biol. 2007 Nov;135(1):35-40. doi: 10.1016/j.ejogrb.2006.10.024. Epub 2006 Nov 28.

    PubMed 17126475

  • Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25.

    PubMed 21788309

  • George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.

    PubMed 23223119

  • Usha Kiran TS, Thakur MB, Bethel JA, Bhal PS, Collis RE. Comparison of continuous infusion versus midwife administered top-ups of epidural bupivacaine for labour analgesia: effect on second stage of labour and mode of delivery. Int J Obstet Anesth. 2003 Jan;12(1):9-11. doi: 10.1016/s0959-289x(02)00158-9.

    PubMed 15676314

Questions about this trial

What is this clinical trial studying?

A study testing Programmed Intermittent bolus, Manual epidural bolus and Levobupivacaine in people with Labor Pain, run by University of Modena and Reggio Emilia at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Stopped funding by Regional Healthcare System.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of instrumental delivery (time frame: Through labor completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02710877, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.

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