Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

NCT03730753 | Unknown FDA Device

• 1 other identifier: 2018 - 2686
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• Dose of bupivacaine in milligrams per hour

  Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours

  1 day

Secondary Outcomes (11)

• Evaluation of pain

  1 day

• Anesthesiologist manual bolus

  1 day

• PCEA boluses received

  1 day

• PCEA boluses requested

  1 day

• Time lapse before the first PCEA request after the epidural connection

  1 day

Study Arms (2)

Control group

ACTIVE COMPARATOR

Continuous infusion + patient controlled epidural analgesia

Device: Continuous infusion

Study group

EXPERIMENTAL

Programmed intermittent epidural bolus + patient controlled analgesia

Device: Programmed intermittent epidural bolus

Interventions

Programmed intermittent epidural bolus DEVICE

Programmed intermittent epidural bolus added to patient controlled epidural analgesia

Study group

Continuous infusion DEVICE

Continuous infusion added to patient controlled epidural analgesia

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

CHUS

Sherbrooke, Quebec, J1H5N4, Canada

RECRUITING

Related Publications (19)

• 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.

  PMID: 15169744 BACKGROUND

• 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.

  PMID: 27591455 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000171109.53832.8d.

  PMID: 16055579 BACKGROUND

• 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. doi: 10.1007/BF03018402.

  PMID: 15197122 BACKGROUND

• 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. doi: 10.1016/j.ijoa.2005.05.004.

  PMID: 16154735 BACKGROUND

• 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. doi: 10.1177/0310057X1003800514.

  PMID: 20865875 BACKGROUND

• 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. doi: 10.1093/bja/ael157. Epub 2006 Jul 18.

  PMID: 16849382 BACKGROUND

• 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. doi: 10.1213/01.ane.0000197778.57615.1a.

  PMID: 16492849 BACKGROUND

• 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.

  PMID: 20832282 BACKGROUND

• 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.

  PMID: 27100210 BACKGROUND

• 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. doi: 10.1213/01.ane.0000253236.89376.60.

  PMID: 17312228 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.

  PMID: 21788309 BACKGROUND

• 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.

  PMID: 26775896 BACKGROUND

• 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 mug/mL. Anesth Analg. 2017 Feb;124(2):537-541. doi: 10.1213/ANE.0000000000001655.

  PMID: 27755057 BACKGROUND

• 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.

  PMID: 21430035 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.

  PMID: 23223119 BACKGROUND

• 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.

  PMID: 27670710 BACKGROUND

• 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. doi: 10.1111/j.1553-2712.1996.tb03402.x.

  PMID: 8808375 BACKGROUND

• 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. doi: 10.1111/j.1553-2712.1998.tb02781.x.

  PMID: 9862594 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Geneviève Rivard, Dr.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Caron, Dr.

CONTACT

+1 819 346-1110; isabelle.caron4@usherbrooke.ca

Geneviève Rivard, Dr.

CONTACT

+1 819 346-1110; genevieve.rivard2@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 27, 2018
• First Posted: November 5, 2018
• Study Start: June 1, 2019
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication for 5 years
• Access Criteria: All access requests and criteria will be reviewed by the investigators of this study.

Locations

CA (1)