Clinical trial NCT02710877: Intermittent Automated Devices for Labor Analgesia in Emilia Romagna
Official title: Pain Management During Labor: Use of Intermittent Drug Delivery Devices for Obstetric and Neonatal Outcome Improvement and Health-care Burden Reduction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Labor Pain
Keywords: epidural analgesia
patient controlled analgesia
obstetric outcome
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 671
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of instrumental delivery
timeFrame: Through labor completion
Secondary outcomes:
measure: Adequate analgesia
timeFrame: Labor length since peridural catheter insertion until delivery
measure: Total amount of local anesthetic
timeFrame: Labor length since peridural catheter insertion until delivery
measure: Time-related amount of local anesthetic
timeFrame: Labor length since peridural catheter insertion until delivery
measure: Motor block episodes
timeFrame: Labor length since peridural catheter insertion until delivery
measure: Anesthesiologist working time
timeFrame: Labor length since peridural catheter insertion until delivery
measure: Health economic assessment
timeFrame: Labor length since peridural catheter insertion until delivery
Other outcomes:
Locations:
city: Carpi
country: Italy
facility: Ospedale Ramazzini di Carpi
state: MO
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
state: PR
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico di Modena
Study officials:
affiliation: University of Modena and Reggio Emilia
name: Massimo Girardis, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.