Intermittent Automated Devices for Labor Analgesia in Emilia Romagna

NCT02710877 | Terminated

• 1 other identifier: CE 274/13
• Study Type: interventional
• Target: 671
• Locations: 1 country
• Sites: 3

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.

Conditions

Labor Pain

Keywords

epidural analgesia; patient controlled analgesia; obstetric outcome

Outcome Measures

Primary Outcomes (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.

  Through labor completion

Secondary Outcomes (6)

• Adequate analgesia

  Labor length since peridural catheter insertion until delivery

• Total amount of local anesthetic

  Labor length since peridural catheter insertion until delivery

• Time-related amount of local anesthetic

  Labor length since peridural catheter insertion until delivery

• Motor block episodes

  Labor length since peridural catheter insertion until delivery

• Anesthesiologist working time

  Labor length since peridural catheter insertion until delivery

Study Arms (2)

Programmed Intermittent bolus (PIEB)

EXPERIMENTAL

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; Drug: Levobupivacaine; Drug: Sufentanil 4 mcg

Manuale epidural bolus (TOP-UP)

ACTIVE COMPARATOR

Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request.

Other: Manual epidural bolus; Drug: Levobupivacaine; Drug: Sufentanil 5 mcg

Interventions

Programmed Intermittent bolus DEVICE

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

Also known as: PIEB

Programmed Intermittent bolus (PIEB)

Manual epidural bolus OTHER

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

Also known as: TOP-UP

Manuale epidural bolus (TOP-UP)

Levobupivacaine DRUG

Levobupivacaine 0,0625% through peridural catheter

Also known as: CHIROCAINE

Manuale epidural bolus (TOP-UP); Programmed Intermittent bolus (PIEB)

Sufentanil 4 mcg DRUG

Sufentanil 0,4 mcg/ml through peridural catheter

Also known as: FENTATIENIL

Programmed Intermittent bolus (PIEB)

Sufentanil 5 mcg DRUG

Sufentanil 5 mcg through peridural catheter

Also known as: FENTATIENIL

Manuale epidural bolus (TOP-UP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (3)

Ospedale Ramazzini di Carpi

Carpi, MO, Italy

Location

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, 41100, Italy

Location

Related Publications (8)

• 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.

  PMID: 16738188 BACKGROUND

• 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.

  PMID: 22161362 BACKGROUND

• 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.

  PMID: 22419342 BACKGROUND

• 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.

  PMID: 15169744 BACKGROUND

• 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.

  PMID: 17126475 BACKGROUND

• 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.

  PMID: 21788309 BACKGROUND

• 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.

  PMID: 23223119 BACKGROUND

• 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.

  PMID: 15676314 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Levobupivacaine; Sufentanil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Massimo Girardis, PhD

  University of Modena and Reggio Emilia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 17, 2016
• Study Start: December 23, 2014
• Primary Completion: December 27, 2017
• Study Completion: February 28, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)