Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

Overview

This study aims to establish if programmed intermittent epidural bolus combined to patient controlled analgesia in labour analgesia will lower the hourly bupivacaine consumption when compared to continuous infusion combined with patient controlled analgesia. The investigators' hypothesis is that the use of programmed intermittent epidural bolus will lower the hourly bupivacaine consumption.

Full Title of Study: “Programmed Intermittent Epidural Bolus Versus Continuous Infusion When Added to Patient-controlled Epidural Analgesia on Bupivacaine Consumption in Labour Analgesia: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 30, 2020

Interventions

  • Device: Programmed intermittent epidural bolus
    • Programmed intermittent epidural bolus added to patient controlled epidural analgesia
  • Device: Continuous infusion
    • Continuous infusion added to patient controlled epidural analgesia

Arms, Groups and Cohorts

  • Active Comparator: Control group
    • Continuous infusion + patient controlled epidural analgesia
  • Experimental: Study group
    • Programmed intermittent epidural bolus + patient controlled analgesia

Clinical Trial Outcome Measures

Primary Measures

  • Dose of bupivacaine in milligrams per hour
    • Time Frame: 1 day
    • Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours

Secondary Measures

  • Evaluation of pain
    • Time Frame: 1 day
    • Hourly pain measurement by visual analog scale, 0/10 being no pain and 10/10 being the worst pain imaginable
  • Anesthesiologist manual bolus
    • Time Frame: 1 day
    • Total boluses by the anesthesiologist
  • PCEA boluses received
    • Time Frame: 1 day
    • PCEA boluses received
  • PCEA boluses requested
    • Time Frame: 1 day
    • PCEA boluses requested
  • Time lapse before the first PCEA request after the epidural connection
    • Time Frame: 1 day
    • Time lapse before the first PCEA request after the epidural connection
  • First stage
    • Time Frame: 1 day
    • Duration of the first stage of labour
  • Second stage
    • Time Frame: 1 day
    • Duration of the second stage of labour
  • Assisted vaginal delivery
    • Time Frame: 1 day
    • Number of assisted vaginal delivery (vacuum, forceps)
  • Cesarean section
    • Time Frame: 1 day
    • Number of unplanned cesarean section
  • Motor blockade
    • Time Frame: 1 day
    • Number of patients with a Bromage score ≥1
  • Patient satisfaction
    • Time Frame: 1 day
    • Satisfaction of the analgesia provided by the epidural on a visual analog scale of 0-100, 0/100 being no satisfaction at all and 100/100 being entirely satisfied

Participating in This Clinical Trial

Inclusion Criteria

  • Pregnant nulliparous or multiparous woman in labour
  • Age ≥18 years
  • Obtained consent for epidural analgesia
  • ASA classification I-II-III
  • Early labour (cervical dilation ≤6cm)

Exclusion Criteria

  • Pregnancy-related comorbidities (preeclampsia, eclampsia, gestational diabetes, large for gestational age fetus)
  • Prematurity (<36 weeks of gestation)
  • Multiple gestation
  • Fentanyl allergy or hypersensitivity
  • Patient unable to understand the PCEA
  • Fetal breech position
  • Maternal cardiac pathology and contraindication to Valsalva manoeuvre
  • Patient with a pain visual analog scale (VAS) not ≤1/10 20 minutes after the anesthesiologist's initial bolus
  • Intrathecal catheter or intravascular catheter
  • Accidental dural puncture
  • Patient refusal
  • Patient with a history of chronic pain (pain lasting more than 3 months) or fibromyalgia

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Université de Sherbrooke
  • Provider of Information About this Clinical Study
    • Principal Investigator: Geneviève Rivard, Principal investigator – Université de Sherbrooke
  • Overall Official(s)
    • Geneviève Rivard, Dr., Principal Investigator, Université de Sherbrooke
  • Overall Contact(s)
    • Isabelle Caron, Dr., +1 819 346-1110, isabelle.caron4@usherbrooke.ca

References

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.

Nunes J, Nunes S, Veiga M, Cortez M, Seifert I. A prospective, randomized, blinded-endpoint, controlled study – continuous epidural infusion versus programmed intermittent epidural bolus in labor analgesia. Braz J Anesthesiol. 2016 Sep-Oct;66(5):439-44. doi: 10.1016/j.bjane.2014.12.006. Epub 2015 Nov 19.

Salim R, Nachum Z, Moscovici R, Lavee M, Shalev E. Continuous compared with intermittent epidural infusion on progress of labor and patient satisfaction. Obstet Gynecol. 2005 Aug;106(2):301-6.

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.

Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005 Oct;14(4):305-9.

Lim Y, Chakravarty S, Ocampo CE, Sia AT. Comparison of automated intermittent low volume bolus with continuous infusion for labour epidural analgesia. Anaesth Intensive Care. 2010 Sep;38(5):894-9.

Fettes PD, Moore CS, Whiteside JB, McLeod GA, Wildsmith JA. Intermittent vs continuous administration of epidural ropivacaine with fentanyl for analgesia during labour. Br J Anaesth. 2006 Sep;97(3):359-64. Epub 2006 Jul 18.

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.

Leo S, Ocampo CE, Lim Y, Sia AT. A randomized comparison of automated intermittent mandatory boluses with a basal infusion in combination with patient-controlled epidural analgesia for labor and delivery. Int J Obstet Anesth. 2010 Oct;19(4):357-64. doi: 10.1016/j.ijoa.2010.07.006. Epub 2010 Sep 15.

Tien M, Allen TK, Mauritz A, Habib AS. A retrospective comparison of programmed intermittent epidural bolus with continuous epidural infusion for maintenance of labor analgesia. Curr Med Res Opin. 2016 Aug;32(8):1435-40. doi: 10.1080/03007995.2016.1181619. Epub 2016 May 20.

Sia AT, Lim Y, Ocampo C. A comparison of a basal infusion with automated mandatory boluses in parturient-controlled epidural analgesia during labor. Anesth Analg. 2007 Mar;104(3):673-8.

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.

McKenzie CP, Cobb B, Riley ET, Carvalho B. Programmed intermittent epidural boluses for maintenance of labor analgesia: an impact study. Int J Obstet Anesth. 2016 May;26:32-8. doi: 10.1016/j.ijoa.2015.11.005. Epub 2015 Nov 27.

Epsztein Kanczuk M, Barrett NM, Arzola C, Downey K, Ye XY, Carvalho JC. Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Biased-Coin Up-and-Down Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 10 mL of Bupivacaine 0.0625% With Fentanyl 2 μg/mL. Anesth Analg. 2017 Feb;124(2):537-541. doi: 10.1213/ANE.0000000000001655.

Wong CA, McCarthy RJ, Hewlett B. The effect of manipulation of the programmed intermittent bolus time interval and injection volume on total drug use for labor epidural analgesia: a randomized controlled trial. Anesth Analg. 2011 Apr;112(4):904-11. doi: 10.1213/ANE.0b013e31820e7c2f.

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.

Lee L, Dy J, Azzam H. Management of Spontaneous Labour at Term in Healthy Women. J Obstet Gynaecol Can. 2016 Sep;38(9):843-865. doi: 10.1016/j.jogc.2016.04.093. Epub 2016 Jun 25.

Todd KH, Funk JP. The minimum clinically important difference in physician-assigned visual analog pain scores. Acad Emerg Med. 1996 Feb;3(2):142-6.

Singer AJ, Thode HC Jr. Determination of the minimal clinically significant difference on a patient visual analog satisfaction scale. Acad Emerg Med. 1998 Oct;5(10):1007-11.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.