Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03730753
• Other study ID #: 2018 - 2686
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Université de Sherbrooke
• Contact: Isabelle Caron, Dr.
• Phone: +1 819 346-1110
• Email: isabelle.caron4[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients are randomised to receive either a programmed bolus of 6ml each 45 minutes or a continuous infusion of 8ml/h. In each group, they have the possibility to add a PCEA bolus of 6ml every 20min as needed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

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

Locations

Country	Name	City	State
Canada	CHUS	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

References & Publications (19)

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

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. — View Citation

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. — View Citation

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. — 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. Erratum In: Anesth Analg. 2013 Jun;116(6):1385. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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. doi: 10.1136/bmj.38097.590810.7C. Epub 2004 May 28. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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. doi: 10.1213/01.ane.0000197778.57615.1a. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of pain	Hourly pain measurement by visual analog scale, 0/10 being no pain and 10/10 being the worst pain imaginable	1 day
Secondary	Anesthesiologist manual bolus	Total boluses by the anesthesiologist	1 day
Secondary	PCEA boluses received	PCEA boluses received	1 day
Secondary	PCEA boluses requested	PCEA boluses requested	1 day
Secondary	Time lapse before the first PCEA request after the epidural connection	Time lapse before the first PCEA request after the epidural connection	1 day
Secondary	First stage	Duration of the first stage of labour	1 day
Secondary	Second stage	Duration of the second stage of labour	1 day
Secondary	Assisted vaginal delivery	Number of assisted vaginal delivery (vacuum, forceps)	1 day
Secondary	Cesarean section	Number of unplanned cesarean section	1 day
Secondary	Motor blockade	Number of patients with a Bromage score =1	1 day
Secondary	Patient satisfaction	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	1 day