Intermittent Automated Devices for Labor Analgesia in Emilia Romagna
NCT ID: NCT02710877
Last Updated: 2018-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
671 participants
INTERVENTIONAL
2014-12-23
2018-02-28
Brief Summary
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Moreover it will evaluate if automated devices can allow a reduction of health-care burden.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Levobupivacaine
Levobupivacaine 0,0625% through peridural catheter
Sufentanil 4 mcg
Sufentanil 0,4 mcg/ml through peridural catheter
Manuale epidural bolus (TOP-UP)
Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request.
Manual epidural bolus
Epidural bolus of 15 ml levobupivacaine and sufentanyl 10 mcg or 5 mcg administered by anesthesist on maternal request.
Levobupivacaine
Levobupivacaine 0,0625% through peridural catheter
Sufentanil 5 mcg
Sufentanil 5 mcg through peridural catheter
Interventions
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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.
Manual epidural bolus
Epidural bolus of 15 ml levobupivacaine and sufentanyl 10 mcg or 5 mcg administered by anesthesist on maternal request.
Levobupivacaine
Levobupivacaine 0,0625% through peridural catheter
Sufentanil 4 mcg
Sufentanil 0,4 mcg/ml through peridural catheter
Sufentanil 5 mcg
Sufentanil 5 mcg through peridural catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Numeric Rate Scale \> 5
Exclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Responsible Party
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Laura Rinaldi
Medical Doctor
Principal Investigators
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Massimo Girardis, PhD
Role: STUDY_DIRECTOR
University of Modena and Reggio Emilia
Locations
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Ospedale Ramazzini di Carpi
Carpi, MO, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CE 274/13
Identifier Type: -
Identifier Source: org_study_id
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