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Stopped funding by Regional Healthcare System.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Manuale epidural bolus (TOP-UP) | Active Comparator | Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adequate analgesia | Mean Numeric Rate Scale values < 5 through labor analgesia | Labor length since peridural catheter insertion until delivery |
| Total amount of local anesthetic | Total amount of levobupivacaine (mg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Girardis, PhD | University of Modena and Reggio Emilia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Ramazzini di Carpi | Carpi | MO | Italy | |||
| Azienda Ospedaliero-Universitaria di Parma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16738188 | Background | 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. | |
| 22161362 | 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. |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Manual epidural bolus | Other | Epidural bolus of 15 ml levobupivacaine and sufentanyl 10 mcg or 5 mcg administered by anesthesist on maternal request. |
|
|
| Levobupivacaine | Drug | Levobupivacaine 0,0625% through peridural catheter |
|
|
| Sufentanil 4 mcg | Drug | Sufentanil 0,4 mcg/ml through peridural catheter |
|
|
| Sufentanil 5 mcg | Drug | Sufentanil 5 mcg through peridural catheter |
|
|
| Labor length since peridural catheter insertion until delivery |
| Time-related amount of local anesthetic | Amount of levobupivacaine for minute of analgesia (mg/min) | Labor length since peridural catheter insertion until delivery |
| Motor block episodes | Number of patients with motor block episodes, defined by modified Bromage score >1 | Labor length since peridural catheter insertion until delivery |
| Anesthesiologist working time | Total time spent in labor room by anesthesiologist (minutes) | Labor length since peridural catheter insertion until delivery |
| Health economic assessment | Total epidural analgesia charge | Labor length since peridural catheter insertion until delivery |
| Parma |
| PR |
| Italy |
| Azienda Ospedaliero-Universitaria Policlinico di Modena | Modena | 41100 | Italy |
| 22419342 | 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. |
| 15169744 | 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. |
| 17126475 | 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. |
| 21788309 | 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. |
| 23223119 | 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. |
| 15676314 | 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. |
| Aniline Compounds |
| D000588 | Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |