Epidural Analgesia During Labour

Analgesia, Epidural Clinical Trial

— PIEBvsPCEA  

Official title:

Epidural Analgesia During Labour Randomized Clinical Trial Comparing Patient Controlled Epidural Analgesia Versus Patient Intermittent Epidural Boluses With Levobupivacaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133091
• Other study ID #: 290587
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: August 2018
• Source: Hospital del Río Hortega
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized single blind trial based on comparing the way the local anesthetic is dosificated during labour. The pain control is evaluated and compared with both dosage techniques (PCEA vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and secondary effects of local anesthetic.

Description:

There is a protocol where every healthy primiparous women have the chance to join the study after the explanation and the informed consent is signed. There are blind envelopes with the two kinds of treatment and the investigator only has to follow the protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 20- 40 years-old women

• Primiparous women

• Dilatation 3- 7 cm

• No risk illnesses for epidural block

• No risk pregnancy

• Signed informed consent

Exclusion Criteria:

• Illnesses which are a risk for pregnancy

• Multiparous women

• Contraindicated diseases for epidural block

• Women who can not understand the procedure

• Women who do not want to sign the informed consent

• Patients with drug´s allergy

Related Conditions & MeSH terms

• Analgesia, Epidural
• Anesthesia, Obstetrical

Intervention

Drug:
• PIEB: Patient Intermittent Epidural Boluses
Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).
• PCEA: Patient Controlled Epidural Analgesia
Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).

Locations

Country	Name	City	State
Spain	Hospital Universitario Rio Hortega	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Río Hortega

Country where clinical trial is conducted

Spain, 

References & Publications (14)

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. — View Citation

Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. — View Citation

Eriksen LM, Nohr EA, Kjaergaard H. Mode of delivery after epidural analgesia in a cohort of low-risk nulliparas. Birth. 2011 Dec;38(4):317-26. doi: 10.1111/j.1523-536X.2011.00486.x. Epub 2011 Sep 6. — 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. Re — View Citation

Gizzo S, Noventa M, Fagherazzi S, Lamparelli L, Ancona E, Di Gangi S, Saccardi C, D'Antona D, Nardelli GB. Update on best available options in obstetrics anaesthesia: perinatal outcomes, side effects and maternal satisfaction. Fifteen years systematic lit — View Citation

Halpern SH, Carvalho B. Patient-controlled epidural analgesia for labor. Anesth Analg. 2009 Mar;108(3):921-8. doi: 10.1213/ane.0b013e3181951a7f. Review. — View Citation

Hiltunen P, Raudaskoski T, Ebeling H, Moilanen I. Does pain relief during delivery decrease the risk of postnatal depression? Acta Obstet Gynecol Scand. 2004 Mar;83(3):257-61. — View Citation

Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for asse — 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. — View Citation

Lieberman E, Lang JM, Cohen A, D'Agostino R Jr, Datta S, Frigoletto FD Jr. Association of epidural analgesia with cesarean delivery in nulliparas. Obstet Gynecol. 1996 Dec;88(6):993-1000. — View Citation

Lin Y, Li Q, Liu J, Yang R, Liu J. Comparison of continuous epidural infusion and programmed intermittent epidural bolus in labor analgesia. Ther Clin Risk Manag. 2016 Jul 14;12:1107-12. doi: 10.2147/TCRM.S106021. eCollection 2016. — View Citation

Melzack R. The myth of painless childbirth (the John J. Bonica lecture). Pain. 1984 Aug;19(4):321-37. Review. — View Citation

Patel RR, Peters TJ, Murphy DJ; ALSPAC Study Team. Prenatal risk factors for Caesarean section. Analyses of the ALSPAC cohort of 12,944 women in England. Int J Epidemiol. 2005 Apr;34(2):353-67. Epub 2005 Jan 19. — View Citation

Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Change from baseline in Visual Analog Scale	4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery
Secondary	Satisfaction (Likert Scale)	1 (very satisfied), 2 (satisfied), 3 (no comments), 4 (not very satisfied), 5 (not satisfied at all)	1 hour after delivery
Secondary	Bromage Scale		15 minutes after Epidural Block and 1 hour after epidural block
Secondary	Labour Outcome	Eutocic	Delivery
Secondary	Labour Outcome	instrumental	Delivery
Secondary	Labour Outcome	cesarean section	Delivery
Secondary	Expulsive time		From 10 cm of dilatation until delivery
Secondary	Apgar at birth	Apgar measured in 1 minute	1 minute after birth
Secondary	Apgar at birth	Apgar measured in 5 minutes	5 minutes after birth
Secondary	fetal pH at birth	0 minutes after delivery	0 minutes after delivery
Secondary	Total Dosis of Levobupivacaine	miligrams	0 minutes after delivery