Intermittent Automated Devices for Labor Analgesia in Emilia Romagna

Labor Pain Clinical Trial

— PA-RER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02710877
• Other study ID #: CE 274/13
• Status: Terminated
• Phase: N/A
• First received: March 8, 2016
• Last updated: March 25, 2018
• Start date: December 23, 2014
• Est. completion date: February 28, 2018

Study information

• Verified date: March 2018
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 671
• Est. completion date: February 28, 2018
• Est. primary completion date: December 27, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

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

Drug:
• 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

Locations

Country	Name	City	State
Italy	Ospedale Ramazzini di Carpi	Carpi	MO
Italy	Azienda Ospedaliero-Universitaria Policlinico di Modena	Modena
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma	PR

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

References & 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. — View 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. Review. — View 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. Epub 2006 Nov 28. — View 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. — View 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. Review. Erratum in: Anesth Analg. 2013 Jun;116(6):1385. — View 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;(3):CD009234. doi: 10.1002/14651858.CD009234.pub2. Review. — View 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. Epub 2004 May 28. Review. — View 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. — View Citation

Outcome

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